Clinical trial · Interventional
Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer
Phase II Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer An Investigator-initiated, Single-institution Trial at Magee-Womens Hospital
NCT01031381CI-TRIAL-00023698RADBEVcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| RAD001 | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Rad001/Bevacizumab
- description
- Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.
- interventionNames
- Drug: RAD001
- Drug: bevacizumab
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) at 6-months
- timeFrame
- Up to 36 months (data collection period for the cohort); Up to 6 months for participant
- description
- The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Secondary outcomes (1)
- measure
- Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.