NCT01012817|Active Not RecruitingPhase 1Results

Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer

A Phase 1/2 Trial of ABT-888, an Inhibitor of Poly(ADP-ribose) Polymerase (PARP), and Topotecan (TPT) in Patients With Solid Tumors (Phase 1) and Relapsed Ovarian Cancer or Primary Peritoneal Cancer (Phase 2) After Prior Platinum Containing First-Line Chemotherapy

National Cancer Institute (NCI)ClinicalTrials.gov

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9 other identifiers

NCI-2011-0031209-000742MC0861MAYO-MC0861CDR00006579768329P50CA136393U01CA069912UM1CA186686

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredNov 2009

StartedNov 2009

CompletionMar 2027

Brief Summary

This phase I/II trial studies the side effects and best dose of veliparib and topotecan hydrochloride and to see how well they work in treating patients with solid tumors, ovarian cancer that has come back or does not respond to treatment, or primary peritoneal cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib with chemotherapy may kill more tumor cells.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

10mo left

Started Nov 2009

Longer than P75 for phase_1

Geographic Reach

1 country

15 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

17.4 years study duration

Study Progress95%

Nov 2009Mar 2027

Study Start

First participant enrolled

November 3, 2009

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2009

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed

9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2019

Completed

4.5 years until next milestone

Results Posted

Study results publicly available

July 19, 2023

Completed

3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2027

Expected

Last Updated

April 29, 2026

Status Verified

March 1, 2026

Enrollment Period

9.2 years

First QC Date

November 11, 2009

Results QC Date

June 29, 2023

Last Update Submit

April 9, 2026

Conditions

Metastatic Malignant Solid Neoplasm Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Unresectable Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)
The number of patients with a dose limiting toxicity will be reported. Dose-limiting toxicity (DLT) will be defined as a cycle 1 adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria: Grade 4 anemia, grade 4 neutrophil count decrease, grade 4 platelet count decrease, Serum creatinine \>= 2 times baseline or ≥ 2 times the upper limit of normal if baseline is \< the upper limit of normal, or other \>= Grade 3 as per NCI Common Terminology Criteria for Adverse Events CTCAE version 4.0. \>= Grade 3 nausea, vomiting, or diarrhea with maximal supportive treatment(s) will be considered dose-limiting. Grade 3 fatigue or anorexia will not be considered dos
4 weeks
Percent of Patients With Tumor Response, Defined as Complete Response or Partial Response as Assessed Using Response Evaluation Criteria In Solid Tumors
The proportion of successes will be estimated by the number of successes(CR or PR) divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987). Complete Response (CR) is defined as disappearance of all target lesions and, if non target lesions exist, the disappearance of all non-target lesions and normalization of tumor maker level. At least 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum.
Up to 48 weeks (12 courses)

Secondary Outcomes (5)

Overall Survival
The time from registration to death due to any cause, assessed up to 5 years
Progression Free Survival
The time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
Duration of Response
Up to 5 years
Time to Treatment Failure
The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, assessed up to 5 years
Adverse Events, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Up to 5 years

Study Arms (1)

Treatment (veliparib and topotecan hydrochloride)

EXPERIMENTAL

Patients receive veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisOther: Pharmacogenomic StudyOther: Pharmacological StudyDrug: Topotecan HydrochlorideDrug: Veliparib