Active Not Recruiting INTERVENTIONAL NCT01012817

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

Sponsor: National Cancer Institute (NCI)

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

Interventions Laboratory Biomarker Analysis Pharmacogenomic Study Pharmacological Study Topotecan Hydrochloride Veliparib

Updated 47 times since 2017 Last updated: Apr 9, 2026 Started: Nov 3, 2009 Primary completion: Jan 13, 2019 Completion: Mar 10, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01012817, this observational or N/A phase trial focuses on Metastatic Malignant Solid Neoplasm and Recurrent Fallopian Tube Carcinoma and remains ongoing. Sponsored by National Cancer Institute (NCI), it has been updated 47 times since 2009, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of the combination of veliparib (ABT-888) and weekly topotecan (topotecan hydrochloride) in adult patients with advanced solid tumors. (Phase I) II. To identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors. (Phase I) III. To assess the confirmed response rate for patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma treated with the combination of ABT-888 and weekly topotecan. IV. To assess the progression free response (PFS) for patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma treated with the combination of ABT-888 and weekly topotecan. (Phase II) SECONDARY OBJECTIVES: I. To identify any pharmacokinetic interactions between ABT-888 and topotecan. (Phase I) II. To determine whether topotecan stimulates adenosine diphosphate (ADP)-ribose polymer formation in circulating peripheral blood mononuclear cells. (Phase I) III. To determine whether ABT-888 inhibits basal or topotecan-stimulated ADP-ribose polymer formation. (Phase I) IV. To assess differences in the toxicity and/or efficacy of this regimen based on BRCA 1/2 mutational status. (Phase II) V. To determine whether pretreatment tumor cell levels of topoisomerase I, poly ADP-ribose polymerase (PARP), BRCA1, BRCA2, XRCC1, tyrosyl-deoxyribonucleic acid...

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose of the combination of veliparib (ABT-888) and weekly topotecan (topotecan hydrochloride) in adult patients with advanced solid tumors. (Phase I) II. To identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors. (Phase I) III. To assess the confirmed response rate for patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma treated with the combination of ABT-888 and weekly topotecan.

IV. To assess the progression free response (PFS) for patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma treated with the combination of ABT-888 and weekly topotecan. (Phase II)

SECONDARY OBJECTIVES:

I. To identify any pharmacokinetic interactions between ABT-888 and topotecan. (Phase I) II. To determine whether topotecan stimulates adenosine diphosphate (ADP)-ribose polymer formation in circulating peripheral blood mononuclear cells. (Phase I) III. To determine whether ABT-888 inhibits basal or topotecan-stimulated ADP-ribose polymer formation. (Phase I) IV. To assess differences in the toxicity and/or efficacy of this regimen based on BRCA 1/2 mutational status. (Phase II) V. To determine whether pretreatment tumor cell levels of topoisomerase I, poly ADP-ribose polymerase (PARP), BRCA1, BRCA2, XRCC1, tyrosyl-deoxyribonucleic acid (DNA) phosphodiesterase 1 (TDP1), P-glycoprotein or breast cancer resistance protein (BCRP) predict response to this regimen. (Phase II) VI. To identify, in an exploratory manner, any transcriptional profiles that may predict response to this regimen. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of veliparib and topotecan hydrochloride followed by a phase II study. (PHASE I DOSE-ESCALATION PART IS COMPLETED)

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

After completion of study treatment, patients are followed up at 3 months (Phase I) or every 3 or 6 months for 5 years (Phase II).

Status Flow

Change History

47 versions recorded

May 4, 2026 — Present [daily]

Active Not Recruiting

Phase: PHASE1/PHASE2 → None
Oct 2025 — May 2026 [monthly]

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▶ Show 42 earlier versions

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Feb 2019 — Mar 2019 [monthly]

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Status: Suspended → Active Not Recruiting
Jan 2019 — Feb 2019 [monthly]

Suspended PHASE1_PHASE2
Dec 2018 — Jan 2019 [monthly]

Suspended PHASE1_PHASE2
Sep 2018 — Dec 2018 [monthly]

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Suspended PHASE1_PHASE2

Status: Recruiting → Suspended
Jun 2018 — Jul 2018 [monthly]

Recruiting PHASE1_PHASE2
Dec 2017 — Jun 2018 [monthly]

Recruiting PHASE1_PHASE2
Oct 2017 — Dec 2017 [monthly]

Recruiting PHASE1_PHASE2
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Apr 2017 — Jun 2017 [monthly]

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Feb 2017 — Apr 2017 [monthly]

Recruiting PHASE1_PHASE2
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE1_PHASE2

First recorded

Nov 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aurora, United States , Chicago, United States , Dallas, United States , Dallas, United States , Fairway, United States , Jacksonville, United States , Lexington, United States , New Lenox, United States , Orland Park, United States , Phoenix, United States and 5 more locations