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NCT00806156 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer
A Phase 2 study, sponsored by Nektar Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 178
- Enrollment target
NCT00806156: Completed Phase 2 study, sponsored by Nektar Therapeutics.
NCT00806156 is a Phase 2 study that has completed, run by Nektar Therapeutics. The registered enrollment target is 178 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00806156, a Phase 2 study, has completed, sponsored by Nektar Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 178 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced platinum-resistant ovarian cancer. Approximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102 will be administered at a dose level of 145 mg/m\^2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. After the initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional patients.
Primary Outcome
The ORR was defined as the proportion of patients with a complete response (CR) or a partial response (PR) per RECIST 1.0 based upon the best response as assessed by the Investigator. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the base
Interventions
- DRUG NKTR-102 q14d
- DRUG NKTR-102 q21d
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2008-10 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT00806156 record still lists
NCT00806156 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% higher).
The record links to 0 conditions, and to 2 interventions - of which NKTR-102 q14d is the first listed.
NCT00806156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00806156 about?
NCT00806156 is a clinical study titled "Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer". This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced platinum-resistant ovarian cancer. Approximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102 will be administered at a dose level of 145 mg/...
What is the current status of trial NCT00806156?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 178 participants. The study started on 2008-10. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00806156?
The interventions under investigation include: NKTR-102 q14d (DRUG), NKTR-102 q21d (DRUG).
Who is sponsoring clinical trial NCT00806156?
This trial is sponsored by Nektar Therapeutics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00806156's enrollment target sits among peer trials
178 391st of 2000 higher than 1,607 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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