Phase 2
N=59
Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer
Ovarian Cancer · Fallopian Tube Cancer · Primary Peritoneal Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01031381 ↗Enrolled (actual)
59
Serious AEs
38.0%
Results posted
Aug 2016
Primary outcome: Primary: Progression-free Survival (PFS) at 6-months — 28 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RAD001 (Drug); bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) at 6-months |
28 | — |
| SECONDARY Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease) |
4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients may or may not have measurable disease. Measurable disease is defined according to RECIST criteria. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation was completed.
- Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy)
- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN.
- Performance status £ 2
- Signed informed consent.
Exclusion Criteria
- Prior treatment with any investigational drug within the preceding 4 weeks
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
- Uncontrolled brain or leptomeningeal metastases
- Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation
- Uncontrolled diabetes mellitus
- A known history of HIV seropositivity
- Impairment of gastrointestinal function or gastrointestinal disease
- Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
- Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control.
- Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
- Patients with a known hypersensitivity to RAD001 (everolimus), other rapamycins (sirolimus, temsirolimus) or excipients, or bevacizumab
- Patients with serious non-healing wound, ulcer, or bone fracture.
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
Data sourced from ClinicalTrials.gov (NCT01031381). 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.