Liposomal Irinotecan + Veliparib for Cancer

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Antiretrovirals, CYP3A4 inhibitors

Disqualifiers: Brain metastases, Lung disease, GI disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of veliparib when given together with liposomal irinotecan in treating patients with solid tumors. Liposomal irinotecan and veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Susan E Bates

Principal Investigator

Yale University Cancer Center LAO

Eligibility Criteria

Adults with solid tumor cancers lacking life-extending standard therapies can join this trial. Prior PARP inhibitor therapy is okay, except for ovarian cancer patients with a BRCA mutation who must have had olaparib. Participants need normal bilirubin levels, acceptable blood counts, and organ function; they should not be pregnant or breastfeeding and must agree to use contraception. Excluded are those with recent chemo/radiotherapy, severe allergies to similar drugs, HIV on antiretrovirals, symptomatic brain metastases, interstitial lung disease, GI disorders preventing pill swallowing.

Inclusion Criteria

Hemoglobin >= 10 g/dL (within 28 days prior to administration of ABT-888)

Leukocytes >= 3,000/mcL (within 28 days prior to administration of ABT-888)

Platelets >= 100,000/mcL (within 28 days prior to administration of ABT-888)

Exclusion Criteria

I have been diagnosed with interstitial lung disease.

I have no major GI issues, except for a past treated bowel blockage.

I have no allergies to veliparib, MM-398, or similar drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive liposomal irinotecan IV over 90 minutes on days 1 and 15 and veliparib PO BID on days 5-12 and 19-25 or 3-12 and 17-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Liposomal Irinotecan
• Veliparib

Trial Overview The trial tests the combination of liposomal irinotecan and veliparib for treating solid tumors by blocking enzymes that promote cell growth. It aims to determine the safest doses while monitoring side effects using MRI scans and biomarker analysis in participants without standard treatment options.

Participant Groups

Group I: Treatment (liposomal irinotecan, veliparib) Experimental Treatment 5 Interventions

Patients receive liposomal irinotecan IV over 90 minutes on days 1 and 15 and veliparib PO BID on days 5-12 and 19-25 or 3-12 and 17-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Within 2-6 days prior to beginning liposomal irinotecan treatment, patients may optionally receive FMX IV and undergo MRI at baseline and 24 hours after FMX infusion.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+