Last reviewed · How we verify
NCT00113256
Randomized Trial of Orathecin and Gemcitabine Versus Placebo and Gemcitabine in Patients With Non-Resectable Pancreatic Cancer Who Have Not Already Received Chemotherapy
Phase 2/Phase 3 trial testing Rubitecan in Pancreatic Cancer in 39 participants. Terminated before completion.
1 February 2006
Quick facts
| Lead sponsor | Astex Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 39 |
| Start date | 1 February 2005 |
| Primary completion | 1 February 2006 |
| Sites | 11 locations across United States |
Drugs / interventions tested
- Rubitecan — full drug profile →
Conditions studied
- Pancreatic Cancer — all drugs for Pancreatic Cancer →
Sponsor
Astex Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with Pancreatic 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.
- survival
Sponsor's own description
Patients will be treated with gemcitabine and Orathecin (rubitecan) capsules to evaluate the current estimate of overall survival as a study endpoint prior to launching the blinded randomized phase (versus gemcitabine and placebo) of the study. Toxicity of the drug combination will also be evaluated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00113256
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Astex Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT05835011 — A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-R · Phase 2 · terminated
- NCT04953923 — Thorough QT Assessment of Cedazuridine in Healthy Subjects · Phase 1 · completed
- NCT04637009 — A Study of TAS1553 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms · Phase 1 · terminated
- NCT04466514 — A Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029 · Phase 1 · completed
- NCT04479800 — Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers · Phase 1 · completed
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 NCT00113256 (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 Astex Pharmaceuticals, Inc.
- Last refreshed: 1 August 2024
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/NCT00113256.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing