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Protocol No. NCI9944

Principal Investigator Barroilhet, Lisa

Phase II

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title Phase 2 Study of M6620 (VX-970) in Combination with gemcitabine versus gemcitabine alone in Subjects with Platinum-Resistant Recurrent Ovarian or Primary Peritoneal Fallopian Tube Cancer

Objective The purpose of this study is to compare any good and bad effects of using a VX-970 along with the usual chemotherapy to using the usual chemotherapy, surgery or radiation approach alone. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Treatment People who are not in a study are usually treated with chemotherapy such as weekly gemcitabine or Doxil which is FDA approved. VX-970 given with gemcitabine is considered investigational. VX-970 has not been approved by the US Food and Drug Administration (FDA) for the treatment of ovarian or fallopian tube or primary peritoneal cancer and can only be given in a research study.

Description This study has two study groups. A computer will by chance assign you to treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the others. All participants receive treatment on a 3 week cycle. Group 1 will get the usual chemotherapy drug, gemcitabine. Group 2 will get the usual chemotherapy drug, gemcitabine, then VX-970. No drugs are given on the third week of a treatment cycle.

Key Eligibility
  • Patients must have histologically confirmed high grade serous ovarian or primary peritoneal or fallopian tube cancer. Platinum Resistant disease is defined as progression within 6 months after last platinum regimen
  • Patients must have measurable disease
  • Prior therapy: No line limit but no more than 1 prior regimens in the platinum resistant setting. No prior treatment targeting the ATR/CHK1 pathway and no prior gemcitabine as single agent. PARP-inhibitors count as line of therapy. Prior carboplatin/gemcitabine is allowed provided that there was no disease progression within 12 months after completion of the carboplatin/gemcitabine regimen
  • Age ≥18 years
  • At least 4 weeks since major surgery or radiation therapy
  • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 6 months after completion of study
  • Patients with primary platinum refractory disease, defined as progression while first line platinum based chemotherapy are excluded
  • Patients who have had radiotherapy within 4 weeks are excluded
  • Patients with known brain metastases are excluded
  • HIV-positive patients on combination antiretroviral therapy are ineligible

Applicable Disease Sites Ovary

Drugs Involved VX-970 (M6620); gemcitabine; gemzar (gemcitabine)

Status Open

Participating Institutions UW Hospital and Clinics