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NCT01366144 · ClinicalTrials.gov registry record · Phase 1
Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction
A Phase 1 study of Melanoma and Breast Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
- 17
- Study locations
NCT01366144: Active Phase 1 study of Melanoma and Breast Carcinoma, sponsored by National Cancer Institute (NCI).
NCT01366144 is a Phase 1 study of Melanoma and Breast Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 94 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (87% lower). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01366144, a Phase 1 study of Melanoma and Breast Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
- 17
- Study locations
Study Summary
This phase I trial studies the side effects and the best dose of veliparib when given together with paclitaxel and carboplatin in treating patients with solid tumors that are metastatic or cannot be removed by surgery and liver or kidney dysfunction. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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 together with paclitaxel and carboplatin may kill more tumor cells.
Primary Outcome
Standard quantitative and graphical statistical summaries of the derived PK parameters (e.g. area under curve and clearance) will be produced for each organ function cohort. The effect of dysfunction on pharmacokinetics will be explored by comparing each pharmacokinetic parameter across all cohorts using one-way analysis (analysis of variance) or Kruskal-Wallis test. The level of each protein will be compared between responders and non-responders using the Wilcoxon signed rank test.
Conditions Studied
Interventions
- DRUG Carboplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- OTHER Pharmacological Study
- DRUG Veliparib
Study Locations (17)
California
- City of Hope Comprehensive Cancer Center - Duarte
- University of California Davis Comprehensive Cancer Center - Sacramento
- City of Hope South Pasadena - South Pasadena
New York
- Memorial Sloan Kettering Cancer Center - New York
- Montefiore Medical Center-Weiler Hospital - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
Pennsylvania
- Penn State Milton S Hershey Medical Center - Hershey
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2011-06-20 |
| Est. Completion | 2027-03-03 |
| Phase | Phase 1 |
What the registry record for NCT01366144 still lists
NCT01366144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (87% lower).
The record links to 10 conditions, with Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT01366144 lists 17 locations in 12 states (California, New York, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT01366144 about?
NCT01366144 is a clinical study titled "Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction". This phase I trial studies the side effects and the best dose of veliparib when given together with paclitaxel and carboplatin in treating patients with solid tumors that are metastatic or cannot be removed by surgery and liver or kidney dysfunction. Veliparib may stop the growth of tumor cells by b...
What is the current status of trial NCT01366144?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2011-06-20. Estimated completion is 2027-03-03.
What conditions does trial NCT01366144 study?
This clinical trial studies the following conditions: Melanoma, Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Lung Carcinoma, Endometrial Carcinoma.
What interventions are being tested in trial NCT01366144?
The interventions under investigation include: Carboplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Pharmacological Study (OTHER), Veliparib (DRUG).
Who is sponsoring clinical trial NCT01366144?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01366144 being conducted?
This trial has 17 study locations across California, Florida, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
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 NCT01366144's enrollment target sits among peer trials
94 116th of 266 higher than 150 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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
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