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Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess progression-free survival of RAD001 at two months in patients with metastatic pancreatic cancer whose disease has progressed on gemcitabine chemotherapy.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Charles Fuchs, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

06-197

NCT ID:

NCT00409292

Start Date:

January 2007

Completion Date:

May 2009

Related Keywords:

  • Pancreatic Cancer
  • RAD001
  • metastatic pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617