Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01012817 · ClinicalTrials.gov registry record · Phase 1
Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Recurrent Ovarian Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
- 15
- Study locations
NCT01012817: Active Phase 1 study of Metastatic Malignant Solid Neoplasm and Recurrent Ovarian Carcinoma, sponsored by National Cancer Institute (NCI).
NCT01012817 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Recurrent Ovarian Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 88 participants, below the 205-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (57% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01012817, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Recurrent Ovarian Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
- 15
- Study locations
Study 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.
Primary Outcome
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 Termin
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
- DRUG Veliparib
- DRUG Topotecan Hydrochloride
- OTHER Pharmacogenomic Study
Study Locations (15)
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- UC Comprehensive Cancer Center at Silver Cross - New Lenox
- University of Chicago Medicine-Orland Park - Orland Park
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Texas
- Parkland Memorial Hospital - Dallas
- UT Southwestern/Simmons Cancer Center-Dallas - Dallas
California
- University of California Davis Comprehensive Cancer Center - Sacramento
Colorado
- UCHealth University of Colorado Hospital - Aurora
Florida
- Mayo Clinic in Florida - Jacksonville
Kansas
- University of Kansas Clinical Research Center - Fairway
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2009-11-03 |
| Est. Completion | 2026-08-27 |
| Phase | Phase 1 |
What the registry record for NCT01012817 still lists
NCT01012817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 205-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (57% lower).
The record links to 5 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01012817 lists 15 locations in 11 states (Illinois, Arizona, Texas).
Frequently Asked Questions
What is clinical trial NCT01012817 about?
NCT01012817 is a clinical study titled "Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer". 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 ...
What is the current status of trial NCT01012817?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2009-11-03. Estimated completion is 2026-08-27.
What conditions does trial NCT01012817 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable Solid Neoplasm.
What interventions are being tested in trial NCT01012817?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Veliparib (DRUG), Topotecan Hydrochloride (DRUG), Pharmacogenomic Study (OTHER).
Who is sponsoring clinical trial NCT01012817?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01012817 being conducted?
This trial has 15 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01012817's enrollment target sits among peer trials
88 33rd of 92 higher than 59 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
RECRUITING · Phase 1
-
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors
RECRUITING · Phase 1
-
Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes
RECRUITING · Phase 1
-
Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
RECRUITING · Phase 1
-
Studying TAK-243 in Patients With Advanced Cancer
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03843463 · 88 participants · Phase 2
Escitalopram and Language Intervention for Subacute Aphasia
- NCT04066348 · 88 participants · Phase 2
TNF-α Treatment of Blast-Induced Tinnitus
- NCT04331704 · 88 participants · Phase 4
ANCHORS Alcohol & Sexual Health Study: UH3 Project
- NCT04536103 · 88 participants
Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI