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Topoisomerase I inhibitor
Veliparib and Irinotecan Hydrochloride in Treating Patients With Cancer That Is Metastatic or Cannot Be Removed by Surgery
Phase 1
Waitlist Available
Led By Patricia M LoRusso
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at days 1, 2, and 3 of course 1 and days 1, 8, 9, and 10 of course 2
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the side effects and best dose of veliparib when given with irinotecan hydrochloride to treat patients with cancer.
Eligible Conditions
- Cancer
- Non-Hodgkin's Lymphoma
- Malignant Tumor
- Hodgkin's Lymphoma
- Colon Cancer
- Ovarian Cancer
- Lung Cancer
- Breast cancer
- Breast Cancer
- Pancreatic Cancer
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at days 1, 2, and 3 of course 1 and days 1, 8, 9, and 10 of course 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at days 1, 2, and 3 of course 1 and days 1, 8, 9, and 10 of course 2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximally tolerated dose (MTD) of study drugs
Maximum administered dose of study drugs
Optimal biologic dose (OBD)
+1 moreSecondary study objectives
Incidence of adverse events (AEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Tumor response
Other study objectives
Change in gamma-H2AX foci and/or Rad51 levels
Change in poly(ADP-ribose) polymerase (PARP) levels in peripheral blood mononuclear cells (PBMCs)
Circulating tumor cell (CTC) counts
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Intermittent dose escalation (irinotecan, ABT-888)Experimental Treatment4 Interventions
Patients receive irinotecan hydrochloride IV over 90 minutes on days 3 and 10 and veliparib PO BID on days 1 to 4 and 8-11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Expansion portion (irinotecan hydrochloride and veliparib)Experimental Treatment4 Interventions
Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and veliparib PO BID on days 1-15 (days 2-15 of course 1 only). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group III: Dose escalation (irinotecan hydrochloride and veliparib)Experimental Treatment4 Interventions
Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and veliparib PO BID on days -1 to 14 (days 3-14 of course 1 only). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Veliparib
2012
Completed Phase 3
~4820
Irinotecan Hydrochloride
2010
Completed Phase 3
~2050
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,143 Total Patients Enrolled
Patricia M LoRussoPrincipal InvestigatorYale University Cancer Center LAO
5 Previous Clinical Trials
306 Total Patients Enrolled