RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

NCT00409292 | Completed Phase 2 Results

• 1 other identifier: 06-197
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pancreatic Cancer

Keywords

RAD001; metastatic pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.

  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.

  two months

Secondary Outcomes (3)

• 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.

• to Assess Response Rate Associated With RAD001 in This Patient Population.

  2 years

• to Assess Overall Survival Associated With RAD001 in This Patient Population.

  2 years

Study Arms (1)

RAD001

EXPERIMENTAL

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.

Drug: RAD001

Interventions

RAD001 DRUG

Taken orally daily for as long as the participant continues to receive a benefit.

RAD001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologic confirmation of pancreatic adenocarcinoma
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Massachusetts General Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Novartis: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Wolpin 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 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Brian Wolpin, MD
• Organization: Dana-Farber Cancer Institute

brian_wolpin@dfci.harvard.edu

617-632-3000

Study Officials

• Charles Fuchs, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Overall PI

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 8, 2006
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 11, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-07

Locations

US (3)