Clinical trial · Interventional
RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
NCT00409292CI-TRIAL-00015364completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAD001 | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RAD001
- description
- RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent. Four weeks of study drug was considered to be one cycle of treatment.
- interventionNames
- Drug: RAD001
Primary outcomes (1)
- measure
- To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.
- timeFrame
- two months
- description
- The Outcome Measure is reporting the number of participants experiencing Progression-free Survival at 2 months after treatment. The study was designed with a primary end point of progression-free survival (PFS), defined as the time from study entry to documentation of progressive disease or death from any cause. On the basis of prior studies of second-line treatment in metastatic pancreatic cancer, we estimated that such treatment has been associated with a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this patient population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic confirmation of pancreatic adenocarcinoma * 18 years of age or older * At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. * Treated with gemcitabine-based chemotherapy with documented tumor progression on gemcitabine or intolerance to gemcitabine. * Prior treatment with no more than 1 prior chemotherapy regimen for metastatic disease. * Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anti-cancer therapy. * ECOG performance status 0-1. * Life expectancy of greater than 12 weeks. * Adequate bone marrow and liver function. * Must be able to swallow tablets. Exclusion Criteria: * Prior treatment with an investigational drug within the preceding 4 weeks. * Prior treatment with an inhibitor of mTOR * Chronic treatment with systemic steroids or another immunosuppressive agent * More than one prior chemotherapy treatment for metastatic disease * Uncontrolled brain or leptomeningeal metastases, including patient who continue to require glucocorticoids for brain or leptomeningeal metastases. * Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin * Patients with chronic renal insufficiency * Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study. * Known history of HIV seropositivity * Impairment of gastrointestinal function or gastrointestinal disease that my significantly alter the absorption of RAD001. * Active, bleeding diathesis or an oral vitamin K antagonist medication * Women who are pregnant or breast feeding
References
Publications (1)
- RESULTWolpin BM, Hezel AF, Abrams T, Blaszkowsky LS, Meyerhardt JA, Chan JA, Enzinger PC, Allen B, Clark JW, Ryan DP, Fuchs CS. Oral mTOR inhibitor everolimus in patients with gemcitabine-refractory metastatic pancreatic cancer. J Clin Oncol. 2009 Jan 10;27(2):193-8. doi: 10.1200/JCO.2008.18.9514. Epub 2008 Dec 1. PMID 19047305