Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970 in Combination With Cytotoxic Chemotherapy

Protocol: OSU-13211

Full Title

An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970 in Combination With Cytotoxic Chemotherapy in Subjects With Advanced Solid Tumors

Purpose

An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics (PK) of VX-970 in Combination With Cytotoxic Chemotherapy in Subjects With Advanced Solid Tumors

Are you eligible?

Inclusion Criteria:

Disease status

  • Parts A and B: Histologically confirmed advanced solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective, or for whom regimens containing gemcitabine, cisplatin, and/or etoposide might be considered, and with measurable disease according to RECIST criteria
  • Part C1:
  • Advanced (Stage IIIB or IV, not eligible for resection or definitive radiotherapy), histologically confirmed squamous non-small cell lung cancer (NSCLC) and who have not previously received chemotherapy for metastatic disease.
  • Either has lesion amenable to biopsy before Day 1 or available archived tumor sample
  • Measurable disease according to RECIST criteria
  • Part C2:
  • Advanced (locally-advanced incurable or metastatic) histologically confirmed estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) negative breast cancer.
  • Received a prior taxane-based regimen and no more than 1 additional regimen in the metastatic setting
  • Either has lesion amenable to biopsy before Day 1 or available archived tumor sample d. Measurable disease according to RECIST criteria
  • Part C3:
  • Histologically confirmed SCLC that has relapsed from, or was refractory to, prior chemotherapy. Refractory disease is defined as relapse within 90 days of completing chemotherapy, or lack of tumor response while on therapy.
  • Either has lesion amenable to biopsy before Day 1 or available archived tumor sample
  • Measurable disease according to RECIST criteria
  • Hematological and biochemical indices within protocol specified ranges at screening.

Exclusion Criteria:

  • Radiotherapy (except for palliative reasons) endocrine therapy, immunotherapy, or chemotherapy during the previous 4 weeks
  • Parts A and B:
  • Greater than 6 cycles of prior treatment with cisplatin and/or carboplatin.

(a) History of prior dose reductions or dose interruptions while receiving cisplatin or carboplatin due to toxicity from the platinum or intolerance to either agent.

  • More than 2 prior distinct chemotherapy regimens used for treatment of advanced stage disease containing DNA damaging agents:
  • Subjects with a history of Grade 3 or 4 thrombocytopenia or Grade 4 neutropenia while receiving prior therapy with cisplatin, carboplatin, or any of the DNA damaging agents listed above.
  • Part C1:
  • prior platinum therapy for squamous NSCLC
  • Received prior treatment for metastatic NSCLC
  • Part C2:
  • More than 2 prior chemotherapy regimens for the treatment of metastatic breast cancer
  • Any prior platinum therapy for breast cancer in any setting
  • Part C3:
  • In relapsed SCLC, more than 2 prior chemotherapy regimens or, in refractory SCLC, more than 1 prior chemotherapy regimen
  • Has not received at least 1 cycle of platinum based chemotherapy for SCLC
  • Unresolved toxicity of Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater from previous anti-cancer therapy or radiotherapy
  • History of brain or leptomeningeal metastases
  • Female subjects who are already pregnant or lactating, or plan to become pregnant within 6 months of the last dose of study drug are excluded. Female subjects of childbearing potential must adhere to contraception guidelines
  • Male subjects with partners of child-bearing potential must agree to adhere to contraception guidelines. Men with pregnant or lactating partners or partners who plan to become pregnant during the study or within 6 months of the last dose of study drug are excluded
  • Major surgery ≤2 weeks before starting study drug, or incomplete recovery from a prior major surgical procedure
  • Serious cardiac or other co-morbid disease, as specified in the protocol
  • Prior bone marrow transplant or extensive radiotherapy to greater than 15% of bone marrow
  • Part C:
  • Current malignancies of other types, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin