Pharmacological Study for Stage IIIA Ovarian Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stage IIIA Ovarian Cancer+28 MorePharmacological Study - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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
  • Stage IIIA Ovarian Cancer
  • Non-Hodgkin's Lymphoma
  • Triple Negative Breast Cancer
  • Unresectable Malignant Tumor
  • Stage III Breast Cancer
  • Unresectable Solid Tumor
  • Stage IIIB Breast Cancer
  • Stage IV Breast Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IVB Colon Cancer
  • Stage III Ovarian Cancer
  • Hodgkin's Lymphoma
  • Stage IV Colon Cancer
  • Cancer
  • Stage III Lung Cancer
  • Stage III Pancreatic Cancer
  • Metastatic Cancer
  • Stage III Colon Cancer
  • Stage IV Pancreatic Cancer
  • Stage IIIA Breast Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Lung Cancer
  • Stage IVA Colon Cancer
  • Stage IIIB Colon Cancer

Treatment Effectiveness

Study Objectives

4 Primary · 2 Secondary · Reporting Duration: Baseline and at days 1, 2, and 3 of course 1 and days 1, 8, 9, and 10 of course 2

Day 1
Pharmacokinetic (PK) profile of veliparib
Day 10
Change in poly(ADP-ribose) polymerase (PARP) levels in peripheral blood mononuclear cells (PBMCs)
Day 9
Change in gamma-H2AX foci and/or Rad51 levels
Hour 28
Irinotecan hydrochloride
Up to 10 days
Poly(ADP-ribose) (PAR) activity inhibition in peripheral blood mononuclear cells and tumor cells
Up to 21 days
Maximally tolerated dose (MTD) of study drugs
Maximum administered dose of study drugs
Recommended phase II dose (RP2D) of study drugs
Up to 30 days
Incidence of adverse events (AEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Pharmacodynamic (PD) parameters
Tumor response
Up to day 15
Circulating tumor cell (CTC) counts
Up to day 8
Excision repair cross-complementation group 1 (ERCC1) expression levels
Day 9
Optimal biologic dose (OBD)

Trial Safety

Trial Design

3 Treatment Groups

Intermittent dose escalation (irinotecan, ABT-888)
1 of 3
Dose escalation (irinotecan hydrochloride and veliparib)
1 of 3
Expansion portion (irinotecan hydrochloride and veliparib)
1 of 3

Experimental Treatment

36 Total Participants · 3 Treatment Groups

Primary Treatment: Pharmacological Study · No Placebo Group · Phase 1

Intermittent dose escalation (irinotecan, ABT-888)Experimental Group · 4 Interventions: Laboratory Biomarker Analysis, Pharmacological Study, Veliparib, Irinotecan Hydrochloride · Intervention Types: Other, Other, Drug, Drug
Dose escalation (irinotecan hydrochloride and veliparib)Experimental Group · 4 Interventions: Laboratory Biomarker Analysis, Pharmacological Study, Veliparib, Irinotecan Hydrochloride · Intervention Types: Other, Other, Drug, Drug
Expansion portion (irinotecan hydrochloride and veliparib)Experimental Group · 4 Interventions: Laboratory Biomarker Analysis, Pharmacological Study, Veliparib, Irinotecan Hydrochloride · Intervention Types: Other, Other, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Veliparib
Not yet FDA approved
Camptothecin
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and at days 1, 2, and 3 of course 1 and days 1, 8, 9, and 10 of course 2

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,070 Previous Clinical Trials
41,128,786 Total Patients Enrolled
21 Trials studying Stage IIIA Ovarian Cancer
5,829 Patients Enrolled for Stage IIIA Ovarian Cancer
Patricia M LoRussoPrincipal InvestigatorYale University Cancer Center LAO
4 Previous Clinical Trials
256 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients enrolled on the expansion portion of the study will consist of two cohorts: those patients who are triple-negative, BRCA-mutant positive and those patients who have triple-negative, non-BRCA mutated breast cancer.
Patient must have measurable disease per RECIST guidelines.
You have received prior experimental (non-FDA approved) therapies and immunotherapies and have full recovery from any acute effects of these therapies.