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NCT00091377
Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous) as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer, Platinum- and/or Taxane-Refractory or Resistant
Phase 1/Phase 2 trial testing cisplatin in Fallopian Tube Cancer in 65 participants. Completed in 1 March 2008.
1 December 2007
Quick facts
| Lead sponsor | MEI Pharma, Inc. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 1 August 2004 |
| Primary completion | 1 December 2007 |
| Estimated completion | 1 March 2008 |
| Sites | 2 locations across United States, Australia |
Drugs / interventions tested
- cisplatin (cisplatin) — full drug profile →
- paclitaxel — full drug profile →
- phenoxodiol — full drug profile →
Conditions studied
- Fallopian Tube Cancer — all drugs for Fallopian Tube Cancer →
- Ovarian Cancer — all drugs for Ovarian Cancer →
- Primary Peritoneal Cavity Cancer — all drugs for Primary Peritoneal Cavity Cancer →
Sponsor
MEI Pharma, Inc. — full company profile →
Who can join
Adults 18 to 120, female only, with Fallopian Tube Cancer or Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety and tolerability
Time frame: Average 6 mo -
Efficacy
Time frame: Average 6 months
Sponsor's own description
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Phenoxodiol may help cisplatin and paclitaxel kill more tumor cells by making tumor cells more sensitive to the drugs. PURPOSE: This randomized phase I/II trial is studying the side effects of phenoxodiol when given together with either cisplatin or paclitaxel and to see how well they work in treating patients with recurrent late-stage ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has not responded to treatment with drugs such as paclitaxel, docetaxel, cisplatin, or carboplatin.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00091377
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Fallopian Tube Cancer
Currently open trials in the same condition.
- NCT07402915 — Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian · Phase 1 · recruiting
- NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting
- NCT06787612 — Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer · Phase 2 · recruiting
- NCT07023484 — Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer · Phase 2 · recruiting
- NCT07460180 — The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cy · Phase 1, PHASE2 · recruiting
Other MEI Pharma, Inc. trials
Trials by the same sponsor.
- NCT05824559 — ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer · Phase 1 · terminated
- NCT05209308 — Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL · Phase 2 · withdrawn
- NCT04745832 — Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL) · Phase 3 · terminated
- NCT03768505 — Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Th · Phase 2 · terminated
- NCT03547115 — A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00091377 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MEI Pharma, Inc.
- Last refreshed: 13 July 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00091377.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing