← Back to Search

Topoisomerase I inhibitor

Pharmacological Study for Hodgkin's Lymphoma

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

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

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

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

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 more

Secondary 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 more

Awards & 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

~4780

Irinotecan Hydrochloride

2010

Completed Phase 3

~2050