Clinical trialPhase 1Completed
Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- February 2004
- Expected end
- October 2009
- Enrollment
- 105 participants
- Sites
- 9
- Primary outcomes
- Determine maximally tolerated dose (MTD); determine dose limiting toxicities.
- Sponsor
- Industry
- Results posted
- No
- Last update
- 15 September 2010
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
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Source text
Brief summary public domain (ClinicalTrials.gov)
AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.
Papers 1
- Registry-listed results paperA phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer. DOI 10.1007/s00280-009-1162-y↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.