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NCT01454089 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study Comparing Chemotherapy in Combination With OGX-427 or Placebo in Patients With Bladder Cancer
A Phase 2 study of Urologic Neoplasms and Metastatic Bladder Cancer, sponsored by Achieve Life Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 183
- Enrollment target
- 20
- Study locations
NCT01454089 is a Phase 2 study of Urologic Neoplasms and Metastatic Bladder Cancer that has completed, run by Achieve Life Sciences. The registered enrollment target is 183 participants, above the 122-participant average among 8 other Urologic Neoplasms trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT01454089, a Phase 2 study of Urologic Neoplasms and Metastatic Bladder Cancer, has completed, sponsored by Achieve Life Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 183 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG OGX-427 600 mg
- DRUG OGX-427 1000 mg
Study Locations (20)
California
- City of Hope National Medical Center - Duarte
- Cedars-Sinai Medical Center - Los Angeles
- University of California Los Angeles - Los Angeles
- USC Norris Comprehensive Cancer Center - Los Angeles
- Radiological Associates of Sacramento - Sacramento
New York
- Monter Cancer Center - Lake Success
- Columbia University Medical Center - New York
- Montefiore Medical Center, Albert Einstein College of Medicine - The Bronx
Ontario
- Juravinski Cancer Centre - Hamilton
- R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health - Oshawa
- Princess Margaret Hospital - Toronto
Alberta
- Tom Baker Cancer Center - Calgary
- Cross Cancer Center - Edmonton
Connecticut
- Yale University - New Haven
Michigan
- Karmanos Cancer Institute - Detroit
Missouri
- Siteman Cancer Center, Washington University School of Medicine - St Louis
Nebraska
- Urology Cancer Center and GU Research Network - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01454089
The ClinicalTrials.gov registry entry for NCT01454089 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 183 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 122-participant average among 8 other Urologic Neoplasms trials with a reported enrollment target (50% higher). The listed sponsor is Achieve Life Sciences, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Urologic Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01454089 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, New York, Ontario.
Frequently Asked Questions
What is clinical trial NCT01454089 about?
NCT01454089 is a clinical study titled "A Phase 2 Study Comparing Chemotherapy in Combination With OGX-427 or Placebo in Patients With Bladder Cancer". The primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm.
What is the current status of trial NCT01454089?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2011-10. Estimated completion is 2014-11.
What conditions does trial NCT01454089 study?
This clinical trial studies the following conditions: Urologic Neoplasms, Metastatic Bladder Cancer, Urinary Tract Neoplasms.
What interventions are being tested in trial NCT01454089?
The interventions under investigation include: Placebo (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), OGX-427 600 mg (DRUG), OGX-427 1000 mg (DRUG).
Who is sponsoring clinical trial NCT01454089?
This trial is sponsored by Achieve Life Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01454089 being conducted?
This trial has 20 study locations across California, Connecticut, Michigan, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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