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

NCT01031381 | Completed Phase 2 Results DMC

• 1 other identifier: 09-01-RAD001BEV
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Keywords

Recurrent; ovarian; fallopian tube; primary peritoneal; cancer; Recurrent ovarian, fallopian tube, primary peritoneal cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) at 6-months

  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).

  Up to 36 months (data collection period for the cohort); Up to 6 months for participant

Secondary Outcomes (1)

• Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)

  Within 4 weeks (28 days) of study treatment initiation (baseline)

Study Arms (1)

Rad001/Bevacizumab

OTHER

Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.

Drug: RAD001; Drug: bevacizumab

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.

Also known as: everolimus, derivative of rapamycin

Rad001/Bevacizumab

bevacizumab DRUG

bevacizumab will be administered intravenously (IV) once every 14 days.

Also known as: Avastin

Rad001/Bevacizumab

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Novartis Pharmaceuticals: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Recurrence; Neoplasms

Interventions

Everolimus; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Rita Johnson, Associate Director of Clinical Research Services
• Organization: UPMC Cancer Centers

johnsonr1@upmc.edu

412-647-8571

Study Officials

• Robert Edwards, MD

  University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 14, 2009
• Study Start: September 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 30, 2016
• Results First Posted: August 30, 2016

Record last verified: 2016-01

Locations

US (1)