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NCT01266447 · ClinicalTrials.gov registry record · Phase 2
Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase 2 study of Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 20
- Study locations
NCT01266447: Completed Phase 2 study of Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT01266447 is a Phase 2 study of Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 121-participant average among 13 other Cervical Squamous Cell Carcinoma trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01266447, a Phase 2 study of Cervical Squamous Cell Carcinoma and Cervical Adenocarcinoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II clinical trial is studying the how well veliparib, topotecan hydrochloride, and filgrastim or pegfilgrastim work in treating patients with persistent or recurrent cervical 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 or by blocking them from dividing. Giving veliparib with chemotherapy may kill more tumor cells. Filgrastim or pegfilgrastim may cause the body to make more blood cells and help it recover from the side effects of chemotherapy.
Primary Outcome
Complete and Partial Tumor Response as Assessed by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Filgrastim
- BIOLOGICAL Pegfilgrastim
- DRUG Veliparib
- DRUG Topotecan Hydrochloride
Study Locations (20)
Michigan
- Saint Joseph Mercy Hospital - Ann Arbor
- Michigan Cancer Research Consortium CCOP - Ann Arbor
- Oakwood Hospital and Medical Center - Dearborn
- Saint John Hospital and Medical Center - Detroit
- Hurley Medical Center - Flint
- Genesys Regional Medical Center - Grand Blanc
- Allegiance Health - Jackson
Illinois
- Decatur Memorial Hospital - Decatur
- Sudarshan K Sharma MD Limted-Gynecologic Oncology - Hinsdale
- Memorial Medical Center - Springfield
Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- The Hospital of Central Connecticut - New Britain
California
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Colorado
- University of Colorado Cancer Center - Anschutz Cancer Pavilion - Aurora
Florida
- Florida Hospital Orlando - Orlando
Georgia
- Memorial University Medical Center - Savannah
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-02 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT01266447 record still lists
NCT01266447 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 121-participant average among 13 other Cervical Squamous Cell Carcinoma trials with a reported enrollment target (78% lower).
The record links to 8 conditions, with Cervical Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01266447 names 20 study sites across 11 states, led by Michigan, Illinois, Connecticut.
Frequently Asked Questions
What is clinical trial NCT01266447 about?
NCT01266447 is a clinical study titled "Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer". This phase II clinical trial is studying the how well veliparib, topotecan hydrochloride, and filgrastim or pegfilgrastim work in treating patients with persistent or recurrent cervical cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs...
What is the current status of trial NCT01266447?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2011-02. Estimated completion is 2016-01.
What conditions does trial NCT01266447 study?
This clinical trial studies the following conditions: Cervical Squamous Cell Carcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Recurrent Cervical Carcinoma, Cervical Small Cell Carcinoma.
What interventions are being tested in trial NCT01266447?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Filgrastim (BIOLOGICAL), Pegfilgrastim (BIOLOGICAL), Veliparib (DRUG), Topotecan Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01266447?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01266447 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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