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NCT00557037
A Phase II Trial of Phenoxodiol in Patients With Castrate and Non-Castrate Prostate Cancer
Phase 2 trial testing Phenoxodiol in Prostate Cancer in 60 participants. Completed in 1 November 2009.
Quick facts
| Lead sponsor | MEI Pharma, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 November 2007 |
| Estimated completion | 1 November 2009 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Phenoxodiol — full drug profile →
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
MEI Pharma, Inc. — full company profile →
Who can join
18 and older, male only, with Prostate 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.
-
The proportion of patients that have a 50% post-therapy PSA decline at 12 weeks in patients with: a)Chemotherapy naïve androgen independent disease (Group A) b)Rising PSA after radical prostatectomy or radiotherapy that are androgen dependent (Group B)
Time frame: 12 weeks
Sponsor's own description
Two groups of patients with prostate cancer will be enrolled: Group A: patients whose cancer has worsened or spread after being on hormonal therapy and has not had any chemotherapy. Group B: patients who have a rising PSA after surgery or radiotherapy for the prostate and do not have any spread to the bones or other organs. Patients will receive Phenoxodiol (PXD) 400 mg every 8 hours daily for 28 consecutive days (1 cycle). Treatment outcome will be evaluated after three cycles (12 weeks) of PXD treatment (immediately prior to cycle 4). Patients with progression of disease will be taken off study. Responding and stable disease patients will remain on study for a total of 12 cycles(approximately 12 months).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Phytochemical-Based Nanomedicine for Advanced Cancer Theranostics: Perspectives on Clinical Trials to Clinical Use.
Dhupal M, Chowdhury D. · · 2020 · cited 48× · PMID 33244231 · DOI 10.2147/ijn.s259628 -
Recent updates on nano-phyto-formulations based therapeutic intervention for cancer treatment.
Wahi A, Bishnoi M, Raina N, Singh MA, et al · · 2023 · cited 20× · PMID 38188681 · DOI 10.32604/or.2023.042228 -
Synthesis of Dextran-Phenoxodiol and Evaluation of Its Physical Stability and Biological Activity.
Yee EMH, Cirillo G, Brandl MB, Black DS, et al · · 2019 · cited 10× · PMID 31440502 · DOI 10.3389/fbioe.2019.00183 -
The role of isoflavones in augmenting the effects of radiotherapy.
Ivashkevich A. · · 2022 · cited 4× · PMID 36936272 · DOI 10.3389/fonc.2022.800562 -
Investigations of Electronic, Structural, and In Silico Anticancer Potential of Persuasive Phytoestrogenic Isoflavene-Based Mannich Bases.
Mutahir S, Khan MA, Mushtaq M, Deng H, et al · · 2023 · cited 3× · PMID 37570881 · DOI 10.3390/molecules28155911
Verify or expand the search:
- PubMed search for NCT00557037
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · 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 NCT00557037 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 6 April 2010
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/NCT00557037.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing