This study is currently recruiting participants.
Number
001886-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Children;Pregnant Women
Keywords
Endometrial Cancer; Ovarian Cancer; Pelcitoclax; Cotellic
Recruitment Keyword(s)
None
Condition(s)
Advanced Endometrial Carcinoma; Metastatic Endometrial Carcinoma; Metastatic Fallopian Tube Carcinoma; Metastatic Platinum-Resistant Ovarian Carcinoma; Metastatic Primary Peritoneal Carcinoma; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Platinum-Resistant Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Stage III Uterine Corpus Cancer AJCC v8; Stage IV Uterine Corpus Cancer AJCC v8
Investigational Drug(s)
APG-1252 (peclitoclax)
Investigational Device(s)
Intervention(s)
Drug: Cobimetinib Drug: APG-1252
Supporting Site
National Cancer Institute
Epithelial ovarian cancer and uterine cancer are the 5th and 6th leading causes of cancer death for women in the United States. Better treatments are needed, especially for cancers that either fail to respond to treatment or return after treatment.
Objective:
To test a combination of two study drugs, APG-1252 and cobimetinib , in people with advanced endometrial or ovarian cancer.
Eligibility:
Adults aged 18 years and older with ovarian cancer that failed to respond or came back after treatment. Adults aged 18 years and older with endometrial cancer that has spread to other parts of the body or cannot be surgically removed.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have an eye exam and tests of their heart function. They will have imaging scans. Some will have biopsies: A sample of tissue will be removed from their tumor before receiving the study drugs and again 10 days later.
Treatment will be administered in 28-day cycles.
APG-1252 is given through a tube attached to a needle inserted into a vein in the arm. Participants will receive APG-1252 once a week.
Cobimetinib is a tablet taken by mouth. Participants will take this pill on the 1st day through the 21st day of each cycle. They will write down the times they take this drug in a medication diary.
Imaging scans, blood tests, and other tests will be repeated at intervals throughout the study. Some participants may have a third, optional biopsy. Some samples will be used for genetic testing.
Participants may remain in the study as long as the treatment is helping them. Follow-up will continue for 30 days after the final treatment.
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Abbreviated Eligibility Criteria: - Age >= 18 years; ECOG <= 2 and adequate organ and marrow function. - Dose escalation patients must have histologically or cytologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, or endometrial cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. - Dose expansion patients must have histologically or cytologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. - Patients must have received at least one prior line of platinum-based systemic therapy. Platinum received together with radiation as a sensitizing agent is not considered a systemic line of therapy. - Patients with low grade serous ovarian cancer must have received a prior MEK inhibitor at a demonstrated therapeutic dose (i.e., trametinib 1mg daily or higher; binimetinib 30mg twice daily or higher). Patients who have had prior cobimetinib must have been able to tolerate cobimetinib at the dose and schedule they would receive it on study. - Patients with MSI or dMMR endometrial cancer must have received prior PD-1 or PD- L1 directed IO therapy or be considered medically ineligible to receive such therapy. - Patients with ovarian cancer must have platinum-resistant disease (progression within 6 months of last receipt of platinum). - Patients should be able to swallow oral therapy. - Patients on Dose Level 2 or higher in the escalation cohort and patients in the expansion cohort must have measurable and biopsiable disease (in a lesion that is not being utilized as a target lesion for RECIST assessment). - Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Patients who have previously received cancer-directed therapeutic agents with the potential for CYP3A4 interaction will be eligible if at least 5 half-lives have elapsed before enrollment. - Patients with evidence of retinal pathology on ophthalmologic examination; or neurosensory retinal detachment, RVO, or neovascular macular degeneration; are ineligible. - Patients with prior exposure to BCL family inhibitors are ineligible. - Patients with a gastrointestinal disorder that may affect absorption of cobimetinib and other oral medications are ineligible. - Patients who have a dependence on IV fluids or total parenteral nutrition are ineligible.
- Age >= 18 years; ECOG <= 2 and adequate organ and marrow function.
- Dose escalation patients must have histologically or cytologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, or endometrial cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Dose expansion patients must have histologically or cytologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Patients must have received at least one prior line of platinum-based systemic therapy. Platinum received together with radiation as a sensitizing agent is not considered a systemic line of therapy.
- Patients with low grade serous ovarian cancer must have received a prior MEK inhibitor at a demonstrated therapeutic dose (i.e., trametinib 1mg daily or higher; binimetinib 30mg twice daily or higher). Patients who have had prior cobimetinib must have been able to tolerate cobimetinib at the dose and schedule they would receive it on study.
- Patients with MSI or dMMR endometrial cancer must have received prior PD-1 or PD- L1 directed IO therapy or be considered medically ineligible to receive such therapy.
- Patients with ovarian cancer must have platinum-resistant disease (progression within 6 months of last receipt of platinum).
- Patients should be able to swallow oral therapy.
- Patients on Dose Level 2 or higher in the escalation cohort and patients in the expansion cohort must have measurable and biopsiable disease (in a lesion that is not being utilized as a target lesion for RECIST assessment).
- Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Patients who have previously received cancer-directed therapeutic agents with the potential for CYP3A4 interaction will be eligible if at least 5 half-lives have elapsed before enrollment.
- Patients with evidence of retinal pathology on ophthalmologic examination; or neurosensory retinal detachment, RVO, or neovascular macular degeneration; are ineligible.
- Patients with prior exposure to BCL family inhibitors are ineligible.
- Patients with a gastrointestinal disorder that may affect absorption of cobimetinib and other oral medications are ineligible.
- Patients who have a dependence on IV fluids or total parenteral nutrition are ineligible.
Principal Investigator
Referral Contact
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