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NCT01696032 · ClinicalTrials.gov registry record · Phase 2
SGI-110 in Combination With Carboplatin in Ovarian Cancer
A Phase 2 study, sponsored by Astex Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT01696032: Completed Phase 2 study, sponsored by Astex Pharmaceuticals.
NCT01696032 is a Phase 2 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01696032, a Phase 2 study, has completed, sponsored by Astex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
A 2-part, Phase 2 controlled, open-label, randomized study in participants with platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on safety and efficacy. In Part 2, participants were randomized to receive the dose identified in Part 1 plus carboplatin or one of four treatment of choice at the discretion of the investigator. The treatment of choice consisted of topotecan, pegylated liposomal doxorubicin, paclitaxel or gemcitabine.
Primary Outcome
Number of participants with dose limiting toxicities (DLTs) in Stage 1
Interventions
- DRUG Carboplatin
- DRUG SGI-110
- DRUG Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
What the finished NCT01696032 record still lists
NCT01696032 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT01696032 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01696032 about?
NCT01696032 is a clinical study titled "SGI-110 in Combination With Carboplatin in Ovarian Cancer". A 2-part, Phase 2 controlled, open-label, randomized study in participants with platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on safety and efficacy. In Part 2, partici...
What is the current status of trial NCT01696032?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2012-09. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01696032?
The interventions under investigation include: Carboplatin (DRUG), SGI-110 (DRUG), Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine) (DRUG).
Who is sponsoring clinical trial NCT01696032?
This trial is sponsored by Astex Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01696032's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 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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