Phase 2
Completed N=33
RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov NCT00409292 ↗Enrolled (actual)
33
Serious AEs
75.8%
Results posted
Aug 2014
Primary outcomePrimary: To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy. — 23 participants — p=0.10
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy. |
23 | 0.10 |
| SECONDARY To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer |
33 | — |
| SECONDARY to Assess Response Rate Associated With RAD001 in This Patient Population. |
7; 22 | — |
| SECONDARY to Assess Overall Survival Associated With RAD001 in This Patient Population. |
4.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00409292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.