Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT01031381
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RAD001 — DRUG
    RAD001 10mg is taken orally (by mouth) once daily on a continuous basis. RAD001 is provided in tablet form and should be taken with a big glass of water on an empty stomach or after a low-fat meal.
  • bevacizumab — DRUG
    bevacizumab will be administered intravenously (IV) once every 14 days.

Study Details

This study will investigate the efficacy as well as the safety of RAD001 in combination with bevacizumab for recurrent ovarian, peritoneal, and fallopian tube cancer. RAD001 will be taken orally once daily and bevacizumab will be administered once every 14 days. The study will be conducted over a period of about 3 to 4 years.

Key Dates

First listed
Dec 14, 2009
Start date
Sep 30, 2010
Status verified
Jan 2016
Primary completion
Jan 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Rad001/Bevacizumab
    Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.

Primary Outcome Measure

Progression-free Survival (PFS) at 6-months [ Time Frame: Up to 36 months (data collection period for the cohort); Up to 6 months for participant ]

Locations (1)

FacilityCityStateZIPSite coordinators
Magee-Womens Hospital of UPMCPittsburghPennsylvania15213-

Find similar trials in Pittsburgh, PA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Magee-Womens Hospital of UPMC· Pittsburgh, PA

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