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NCT00770536 · ClinicalTrials.gov registry record · Phase 1
AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR
A Phase 1 study of Cancer and Ovarian Cancer, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
- 16
- Study locations
NCT00770536: Completed Phase 1 study of Cancer and Ovarian Cancer, sponsored by Amgen.
NCT00770536 is a Phase 1 study of Cancer and Ovarian Cancer that has completed, run by Amgen. The registered enrollment target is 103 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00770536, a Phase 1 study of Cancer and Ovarian Cancer, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
- 16
- Study locations
Study Summary
This study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386 in combination with either pegylated liposomal doxorubicin or topotecan in subjects with recurrent ovarian cancer. Up to 100 subjects will be enrolled to receive AMG 386 in combination with either pegylated liposomal doxorubicin every 4 weeks (cohort A) or topotecan weekly on days 1, 8, and 15 of a 28 day dosing schedule (cohort B). Subject enrollment and assignment to either cohort will be based on eligibility and the investigator's discretion. It is hypothesized that AMG 386, in combination with each of the chemotherapy regimens: either pegylated liposomal doxorubicin or topotecan will be safe and well tolerated in subjects with recurrent ovarian cancer.
Conditions Studied
Interventions
- DRUG A1: AMG 386 10 mg/kg + Liposomal doxorubicin
- DRUG A3: AMG 386 15mg/kg + Liposomal doxorubicin
- DRUG B1: AMG 386 10 mg/kg + Topotecan
- DRUG B3: AMG 386 15mg/kg + Topotecan
Study Locations (16)
Other
- Research Site - Leuven
- Research Site - Liège
- Research Site - Liège
- Research Site - Wilrijk
Florida
- Research Site - Orlando
- Research Site - Tampa
Victoria
- Research Site - Footscray
- Research Site - Parkville
Arizona
- Research Site - Tucson
California
- Research Site - Sacramento
Minnesota
- Research Site - Saint Louis Park
North Carolina
- Research Site - Winston-Salem
North Dakota
- Research Site - Bismarck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2009-01 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT00770536 record still lists
NCT00770536 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower).
The record links to 9 conditions, with Cancer appearing as the primary indexed condition, and to 4 interventions - of which A1: AMG 386 10 mg/kg + Liposomal doxorubicin is the first listed.
NCT00770536 lists 16 locations in 11 states (Other, Florida, Victoria).
Frequently Asked Questions
What is clinical trial NCT00770536 about?
NCT00770536 is a clinical study titled "AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR". This study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386 in combination with either pegylated liposomal doxorubicin or topotecan in subjects with recurrent ovarian cancer. Up to 100 subjects will be enrolled to receive AMG 386 in combination with either pegylated ...
What is the current status of trial NCT00770536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2009-01. Estimated completion is 2015-06.
What conditions does trial NCT00770536 study?
This clinical trial studies the following conditions: Cancer, Ovarian Cancer, Solid Tumors, Fallopian Tube Cancer, Carcinoma.
What interventions are being tested in trial NCT00770536?
The interventions under investigation include: A1: AMG 386 10 mg/kg + Liposomal doxorubicin (DRUG), A3: AMG 386 15mg/kg + Liposomal doxorubicin (DRUG), B1: AMG 386 10 mg/kg + Topotecan (DRUG), B3: AMG 386 15mg/kg + Topotecan (DRUG).
Who is sponsoring clinical trial NCT00770536?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00770536 being conducted?
This trial has 16 study locations across Arizona, California, Florida, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00770536's enrollment target sits among peer trials
103 310th of 615 higher than 306 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer 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.
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