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Topoisomerase I inhibitor

Irinotecan Hydrochloride for Breast Cancer

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

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
  • Breast Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Cancer
  • Non-Hodgkin's Lymphoma
  • Colon Cancer
  • Solid Tumors
  • Hodgkin's Lymphoma
  • Malignant Tumor
  • Ovarian Cancer

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at days 1, 2, and 3 of course 1 and days 1, 8, 9, and 10 of course 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximally tolerated dose (MTD) of study drugs
Maximum administered dose of study drugs
Optimal biologic dose (OBD)
+1 more
Secondary outcome measures
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 outcome measures
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 more

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
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Veliparib
2012
Completed Phase 3
~4780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,365 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
Patricia M LoRussoPrincipal InvestigatorYale University Cancer Center LAO
5 Previous Clinical Trials
306 Total Patients Enrolled
~2 spots leftby Jul 2025
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