RO4929097and Bevacizumab in Treating Patients With Progressive or Recurrent Malignant Glioma

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01189240
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor

Eligibility Criteria

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

Interventions

  • gamma-secretase/Notch signalling pathway inhibitor RO4929097 — DRUG
    Given orally
  • bevacizumab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies

Study Details

This phase I/II trial is studying the side effects and the best dose of RO4929097 to see how well it works when given together with bevacizumab compared to bevacizumab alone in treating patients with progressive or recurrent malignant glioma. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving RO4929097 together with bevacizumab may kill more tumor cells.

Key Dates

First listed
Aug 26, 2010
Start date
Dec 31, 2010
Status verified
Oct 2015
Primary completion
Jan 31, 2013
Completion
Feb 28, 2015

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose Finding
    Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: pharmacological study: correlative studies; laboratory biomarker analysis: correlative studies.
  • Experimental: Phase II Stage I
    Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15.Other: laboratory biomarker analysis: correlative studies. Phase 2 - not implemented due to drug supply from company
  • Experimental: Phase II Stage II Arm 1
    Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: laboratory biomarker analysis: correlative studies. Phase 2 - not implemented due to drug supply from company
  • Active Comparator: Phase II Stage II Arm 2
    Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Other: laboratory biomarker analysis: correlative studies. Phase 2 - not implemented due to drug supply from company
  • Experimental: Phase I Dose Finding - Level 1 5mg
    Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: pharmacological study: correlative studies; laboratory biomarker analysis: correlative studies.
  • Experimental: Phase I Dose Finding - Level 2 10mg
    Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: pharmacological study: correlative studies; laboratory biomarker analysis: correlative studies.
  • Experimental: Phase I Dose Finding - Level 3 20mg
    Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: pharmacological study: correlative studies; laboratory biomarker analysis: correlative studies.

Primary Outcome Measure

Maximum-tolerated Dose and the Recommended Phase II Dose of Gamma-secretase Inhibitor RO4929097 in Combination With Bevacizumab Determined by Dose-limiting Toxicity Rate (Phase I) [ Time Frame: 28 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of California at Los Angeles (UCLA )Los AngelesCalifornia90095-
University of California San Francisco Medical Center-ParnassusSan FranciscoCalifornia94143-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Los Angeles, CA

By research site
University of California at Los Angeles (UCLA )· Los Angeles, CAUniversity of California San Francisco Medical Center-Parnassus· San Francisco, CAH. Lee Moffitt Cancer Center and Research Institute· Tampa, FLMemorial Sloan-Kettering Cancer Center· New York, NY

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