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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
  • open for enrollment

    Phase IIB TL + YCWP + DC in Melanoma

    Protocol: OSU-14184

    Eligibility:

    Inclusion Criteria:

    18 years or older

    Eastern Cooperative Oncology Group (ECOG) performance status 0,1 (Appendix D)

    AJCC stage III or IV completely resectable melanoma identified before surgery

    Approximately 1 mg (1 cm3) of accessible and dispensable tumor that will not

    interfere with pathologic staging

    Clinically disease-free after surgery

    Completing SoC adjuvant therapy per NCCN guidelines to include chemotherapy,

    radiation therapy, and/or biologic therapy as clinically indicated. (Consent #2

    should be signed as close to completion of SoC as possible but may overlap completion

    by up to one month.)

    Vaccinations initiated between 3 weeks and 3 months from completion of SoC

    multi-modality cancer care

    Adequate organ function as determined by the following laboratory values:

    ANC ≥ 1,000/μL

    Platelets ≥ 75,000/μL

    Hgb ≥ 9 g/dL

    Creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥ 50%

    Total bilirubin ≤ 1.5 ULN

    ALT and AST ≤ 1.5 ULN

    For women of child-bearing potential, agreement to use adequate birth control

    (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral

    contraception, IUD, or use of condoms or diaphragms)

    Signed informed consent

    Exclusion Criteria:

    Evidence of residual disease after surgery and SoC adjuvant therapies

    Insufficient tumor available to produce vaccine

    ECOG >2 performance status (Appendix D)

    Immune deficiency disease or known history of HIV, HBV, HCV

    Receiving immunosuppressive therapy including chronic steroids, methotrexate, or

    other known immunosuppressive agents

    Pregnancy (assessed by urine HCG)

    Breast feeding

    Active pulmonary disease requiring medication to include multiple inhalers (>2

    inhalers and one containing steroids)

    Involved in other experimental protocols (except with permission of the other study

    PI)

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  • open for enrollment

    The OSU Comprehensive Cancer Center Malignant Melanoma Tissue Bank

    Protocol: OSU-18143

    Principal Investigator: William E Carson, III, MD

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  • open for enrollment

    Ph II Trial of Intermittent Versus Continuous Dosing of Dabrafenib/Trametinib Mutant Melanoma

    Protocol: SWOG-S1320

    Eligibility:

    Inclusion Criteria:

    Patients must have histologically or cytologically confirmed stage IV or unresectable stage III BRAF V600E or BRAF V600K mutant melanoma

    Patients must have BRAF V600E or BRAF V600K mutation identified by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory; acceptable analytic techniques include but are not restricted to deoxyribonucleic acid (DNA) sequencing, pyrosequencing, polymerase chain reaction (PCR), melting point assays, and immunohistochemistry

    Contrast-enhanced computed tomography (CT) scans of the neck, chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the neck, chest, abdomen and pelvis; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; all measurable lesions must be assessed within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)

    Patients must not have received a prior BRAF or mitogen-activated protein kinase kinase (MEK) inhibitor

    Patients must not have brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 7 days prior to registration

    Patients must not have received any anti-cancer drug within 28 days prior to registration, and must not have received any nitrosoureas or mitomycin C within 42 days prior to registration

    Patients must not have received any major surgery or immunotherapy within 28 days prior to registration

    Patients must not have any unresolved toxicity greater than National Cancer Institute (NCI)-CTCAE version (v) 4.0 grade 1 from previous anti-cancer therapy except alopecia within 7 days prior to registration

    Absolute neutrophil count (ANC) >= 1,200/ul

    Platelets >= 100,000/ul

    Hemoglobin >= 9 g/dL

    Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x upper limit of normal [ULN] with Gilbert’s syndrome)

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or < 5 x IULN for patients with known liver metastases)

    Serum albumin >= 2.5 g/dL

    Serum creatinine =< 1.5 x mg/dL OR measured or calculated creatinine clearance >= 50 mL/min; creatinine measurements must be obtained within 28 days prior to registration

    Patients must have lactate dehydrogenase (LDH) obtained within 28 days prior to registration in order to obtain baseline stratification information

    Patients must have a left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (ILLN) by echocardiogram (ECHO) or multi gated acquisition scan (MUGA) within 28 days prior to registration

    Patients must have corrected QT (QTc) =< 480 msec by electrocardiogram (ECG) (corrected using the Bazett’s formula) within 28 days prior to registration

    Patients with known history or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR) are not eligible:

    History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)

    Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:

    • Evidence of new optic disc cupping
    • Evidence of new visual field defects
    • Intraocular pressure > 21 mmHg

    NOTE: ophthalmic exam is required for all patients; exam must be obtained within 28 days prior to registration

    Patients must be able to take oral medications; patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of protocol treatment (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)

    Patients receiving anticoagulation treatment are allowed to participate with international normalized ratio (INR) established within the therapeutic range

    Patients must not have a history of pneumonitis or interstitial lung disease

    Patients must not have any grade II/III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia; abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis]) can be entered on study; patients with a history of atrial fibrillation must have atrial fibrillation controlled for at least 30 days prior to registration

    Patients with known hepatitis B or hepatitis C are not eligible, regardless of concomitant antiretroviral therapy or current viral load

    Patients with known human immunodeficiency virus (HIV) may be eligible providing they meet the following additional criteria:

    Cluster of differentiation (CD)4 cells >= 500/uL

    Serum HIV viral load of < 25,000 IU/ml

    No current antiretroviral therapy

    • Tests must be obtained within 28 days prior to registration; patients who are HIV positive (+) and do not meet all of these criteria are not eligible for this study (HIV/hepatitis testing are not required for patients without known infection)

    Prestudy history and physical must be obtained with 28 days prior to registration

    Patients must have dermatology exam obtained within 28 days prior to registration to obtain baseline measurement; exam to be performed by treating physician or designated dermatologist

    Patients must have Zubrod performance status of 0 or 1

    No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years; exception: patients with known history of colon cancer, cancer of the pancreas, or any cancer known to harbor an activating retrovirus-associated deoxyribonucleic acid (DNA) sequence (RAS) mutation are ineligible regardless of stage or time since diagnosis

    Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures; hormonal contraception is not allowed

    Patients must be offered the opportunity to participate in specimen banking

    Patients with cutaneous or superficial lesions that do not require imaging guidance for biopsy must be willing to undergo biopsies for tissue submission and blood draws for translational medicine

    Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

    As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

    STEP 2: RANDOMIZATION

    After completing one cycle of therapy, patients will be registered for randomization between intermittent and continuous dosing, provided that they were eligible for the initial step 1 registration and satisfy the following criteria

    Patients must not have unequivocal disease progression (by RECIST v1.1) during the first cycle; patients must have disease assessed using the same method as baseline within +/- 5 days of the day 56 scheduled assessment (between days 51-55 of cycle 1, or days 1-5 of cycle 2); all disease must be assessed and documented on the follow-up tumor assessment form (RECIST 1.1)

    Patients must be registered to step 2: randomization within +/- 5 days of starting cycle 2; patients MUST NOT be registered prior to the day 56 disease assessment

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  • open for enrollment

    Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients with Stage III-IV BRAFV600 Melanoma

    Protocol: ECOG-EA6134

    Eligibility:

    Inclusion Criteria:

    STEP 1

    Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1

    Women must not be pregnant or breast-feeding

    All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy

    A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

    Women of child-bearing potential and sexually active males must agree to use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for the duration of their participation in the study, and for 4 weeks after treatment with dabrafenib or for 4 months after dabrafenib in combination with trametinib; women of child-bearing potential must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 5 months after the last dose of nivolumab and/or ipilimumab and sexually active males must use at least two other accepted and effective methods of contraception and/or abstain from sexual intercourse for at least 7 months after the last dose of nivolumab and/or ipilimumab; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately

    Patients must have unresectable stage III or stage IV disease

    Patients must have measurable disease; all sites of disease must be evaluated within 4 weeks prior to randomization

    Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive

    NOTE: Any patient with BRAFV600 E or K mutant melanoma (whether cutaneous, acral or mucosal primary) who meets the eligibility criteria is eligible for participation in this trial; patients with uveal melanoma are not eligible for this trial

    Patients must have BRAFV600E or BRAFV600K mutations, identified by a Food and Drug Administration (FDA)-approved test at a Clinical Laboratory Improvement Amendments (CLIA)-certified lab; if test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test)

    Patients may have had prior systemic therapy in the adjuvant setting; however this adjuvant treatment must not have included a CTLA4 or PD1 pathway blocking antibody or a BRAF/MEK inhibitor; also, patients may not have had any prior systemic treatment for advanced (measurable metastatic) disease

    Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting >= 4 weeks prior to entering the study and recovered from adverse events due to those agents; mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study; patients must have discontinued radiation therapy >= 2 weeks prior to entering the study and recovered from any adverse events associated with treatment; prior surgery must be >= 4 weeks from registration and patients must be fully recovered from post-surgical complications

    Patients must not receive any other investigational agents while on study or within four weeks prior to registration

    Patients are ineligible if they have any currently active central nervous system (CNS) metastases; patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery [SRS]) that have been stable on head magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan for at least 4 weeks following treatment and within 4 weeks of randomization could be eligible; patients must not have taken any steroids =< 14 days prior to randomization for the purpose of managing their brain metastases; patients with only whole brain irradiation for treatment of CNS metastases will be ineligible

    Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for > 3 years prior to the time of registration; patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; Note: prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility

    White blood count >= 3,000/uL

    Absolute neutrophil count (ANC) >= 1,500/uL

    Platelet count >= 100,000/uL

    Hemoglobin > 9 g/dL

    Serum creatinine =< 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) >= 40 ml/min

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x ULN for patients with documented liver metastases)

    Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement)

    Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert’s syndrome

    Serum lactate dehydrogenase (LDH) < 10 X ULN (patients with LDH > 10 X ULN are felt to have aggressive disease and should be considered for BRAF inhibitor therapy off protocol)

    Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, history of bleeding diathesis or need for concurrent anticoagulation (international normalized ratio [INR] =< 1.5 and partial thromboplastin time [PTT] within 1.1 x ULN), or psychiatric illness/social situations that would limit compliance with study requirements, interfere with subject’s safety, or obtaining informed consent; therapeutic level dosing of warfarin can be used with close monitoring of prothrombin time (PT)/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency

    Patients must not have a history of or evidence of cardiovascular risks including any of the following:

    QT interval corrected for heart rate using the Bazett’s formula (QTcB) >= 480 msec. at baseline

    History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to registration

    History prior to registration or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system

    Left ventricular ejection fraction (LVEF) =< lower limit of normal on cardiac echocardiogram (echo) or multi gated acquisition scan (MUGA)

    Intra-cardiac defibrillator

    History of abnormal cardiac valve morphology (>= grade 2) documented by ECHO (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study

    History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible

    Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy

    Individuals who are known to be human immunodeficiency virus (HIV) infected are eligible (note: HIV testing is not required for entry into the study)

    Patients with evidence of active hepatitis B virus (HBV) or hepatitis C Virus (HCV) infection are not eligible; patients with cleared HBV and HCV infection will be allowed

    Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), should be evaluated for the presence of target organ involvement and potential need for systemic treatment; if no systemic immune suppression is deemed necessary they can be eligible

    The following medications or non-drug therapies are also prohibited while on treatment in this study:

    Other anti-cancer therapies

    Other investigational drugs

    Patients taking any medications or substances that are strong inhibitors or inducers of CYP3A or CYP2C8 are ineligible

    Patients must not have history of retinal vein occlusion (RVO)

    Patients must not have evidence of interstitial lung disease or pneumonitis

    Patients must not have malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib

    STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE)

    The patient must have met all eligibility criteria (except as detailed below) at the time of crossover

    RECIST defined measurable disease is not required

    Only prior systemic therapy as part of step 1 is allowed; patients who received allowed systemic therapy in the adjuvant setting prior to Step 1 and were eligible for Step 1 are not excluded from proceeding to Step 2 if they meet other eligibility criteria

    Malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib, or history of retinal vein occlusion are acceptable for patients crossing over to ipilimumab + nivolumab treatment

    History of autoimmune disease, excluding interstitial lung disease or pneumonitis, is allowed in patients crossing over to dabrafenib/trametinib therapy

    Patients can be less than 4 weeks from surgery or SRS to CNS metastases

    There is no restriction on serum LDH at crossover

    Patients with a history of cardiovascular risks that developed during step 1 of therapy should be discussed with study principal investigator (PI) at time of crossover

    Patients must have melanoma that is metastatic and clearly progressive on prior therapy

    Patients must be at least 2 weeks and within 12 weeks from documented progressive disease (PD) on Step 1 of current study; all sites of disease must be evaluated within 4 weeks prior to registration

    Patients must have recovered from adverse events (toxicities resolved to grade 1 or less) of prior therapy; patients with immune related toxicities from ipilimumab + nivolumab may continue onto Step 2 even if still on steroids to control side effects, so long as toxicity has resolved to grade 1 or less

    Patients must have discontinued radiation therapy >= 2 weeks prior to registering to Step 2 of the study and recovered from any adverse events associated with treatment; prior surgery must be >= 2 weeks from registration to Step 2 and patients must be fully recovered from post-surgical complications

    Patients are ineligible if they have any currently active CNS metastases; patients who have treated brain metastases (with either surgical resection or SRS) that have been stable on head MRI or contrast CT scan for at least 4 weeks following treatment and within 4 weeks prior to Step 2 registration are eligible; patients crossing over to ipilimumab + nivolumab must not have taken any steroids =< 14 days prior to registration for the purpose of managing their brain metastases; this exclusion does not apply for patients crossing over to dabrafenib + trametinib; patients with only whole brain irradiation for treatment of CNS metastases are ineligible

    Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast

    Principal Investigator: Joanne Jeter, MD

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  • open for enrollment

    Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

    Protocol: OSU-15172

    Eligibility:

    Inclusion Criteria:

    Histologically- or cytologically-confirmed diagnosis of locally advanced or

    metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement

    Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a

    gene rearrangement of interest may be eligible provided they meet all other

    inclusion/exclusion criteria

    For patients enrolled via local molecular testing, an archival or fresh tumor tissue

    (unless medically contraindicated) is required to be submitted for independent

    central molecular testing at Ignyta's CLIA laboratory post-enrollment

    Measurable or evaluable disease

    Patients with CNS involvement, including leptomeningeal carcinomatosis, which is

    either asymptomatic or previously-treated and controlled, are allowed

    Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1,

    or ALK inhibitors in patients who have tumors that harbor those respective gene

    rearrangements)

    Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged

    NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are

    prohibited.

    At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior

    chemotherapy or small molecule targeted therapy

    At least 4 weeks must have elapsed since completion of antibody-directed therapy

    Prior radiotherapy is allowed if more than 14 days have elapsed since the end of

    treatment

    Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life

    expectancy of 4 weeks

    Adequate organ function as defined per protocol

    Ability to swallow entrectinib intact

    Other protocol specified criteria

    Exclusion Criteria:

    Current participation in another therapeutic clinical trial

    Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in

    patients who have tumors that harbor those respective gene rearrangements

    Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged

    NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are

    prohibited.

    History of other previous cancer that would interfere with the determination of

    safety or efficacy

    Incomplete recovery from any surgery

    History of non-pharmacologically induced prolonged QTc interval

    History of additional risk factors for torsade de pointes

    Peripheral neuropathy Grade ≥ 2

    Known active infections

    Active gastrointestinal disease or other malabsorption syndromes

    Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase

    inhibitor-induced pneumonitis

    Other protocol specified criteria

    Principal Investigator: Gregory A Otterson, MD

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