Clinical trialPhase 2Completed
RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- January 2007
- Expected end
- May 2009
- Enrollment
- 33 participants
- Sites
- 3
- Primary outcomes
- To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.
- Sponsor
- Other
- Results posted
- 2014-08-11
- Last update
- 11 August 2014
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.
Detailed description public domain (ClinicalTrials.gov)
* Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day. * Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor. * Participants will remain on the study as long as they continue to benefit from the study medication.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy. [two months]. Number, participants. RAD001 (n=29): 23. Analysis, RAD001: p=0.10; binomial hypothesis test; superiority or other.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer [Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001.]. Number, participants. RAD001 (n=33): 33.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
to Assess Response Rate Associated With RAD001 in This Patient Population. [2 years]. Number, participants. Stable Disease as Best Response: RAD001 (n=29): 7. Progressive Disease as Best Response: RAD001 (n=29): 22.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
to Assess Overall Survival Associated With RAD001 in This Patient Population. [2 years]. Median, months (Full Range). RAD001 (n=29): 4.5 (0.97 to 15.43).
Papers 1
- Registry-listed results paperOral mTOR inhibitor everolimus in patients with gemcitabine-refractory metastatic pancreatic cancer. DOI 10.1200/jco.2008.18.9514↗
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.