A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma

NCT01474239 | Completed Phase 2 Results

• 1 other identifier: ML25739
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 10

Brief Summary

This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Alive 6 Months After Start of Treatment

  Overall survival (OS) was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of magnetic resonance imaging (MRI) assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.

  6 months

• Overall Survival (OS)

  OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.

  Baseline until death (up to 691 days)

Secondary Outcomes (14)

• Percentage of Participants Who Were Alive and Progression Free 6 Months After Start of Treatment

  6 months

• Progression-Free Survival (PFS)

  Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days)

• Percentage of Participants Alive 9 Months After Start of Treatment

  9 months

• Percentage of Participants Alive 12 Months After Start of Treatment

  12 months

• Percentage of Participants Alive 30 Days After Last Dose of Study Drug

  30 days after last dose of study drug (up to Day 600)

Study Arms (2)

Calibration Arm

EXPERIMENTAL

Drug: fotemustine

Investigational Arm

EXPERIMENTAL

Drug: bevacizumab [Avastin]

Interventions

bevacizumab [Avastin] DRUG

10 mg/kg every 2 weeks intravenously until disease progression or unacceptable toxicity

Investigational Arm

fotemustine DRUG

75 mg/m2 intravenously on days 1, 8 and 15 followed by, after a 5 weeks interval, 100 mg/m2 on day 1 of a 3-weeks cycle. Until disease progression or unacceptable toxicity

Calibration Arm

Eligibility Criteria

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

You may qualify if:

• Adult patients, \>/=18 years of age
• Diagnosis of recurrent glioblastoma multiforme (Grade IV)
• Previous treatment with temozolomide and radiotherapy
• First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy)
• Adequate hematological, biochemical and organ functions

You may not qualify if:

• Previous treatment with Avastin or other anti-angiogenic drugs
• Residual relevant toxicity resulting from previous therapy
• Radiotherapy within the 3 months prior to the diagnosis of disease progression
• Chemotherapy in the previous 4 weeks
• Other active or inactive malignancies (except for carcinoma in situ of the cervix, of the prostate or basal cell carcinoma)
• Clinically significant cardiovascular diseases

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (10)

Unknown Facility

San Giovanni Rotondo, Apulia, 71013, Italy

Location

Unknown Facility

Napoli, Campania, 80131, Italy

Location

Unknown Facility

Bologna, Emilia-Romagna, 40133, Italy

Location

Unknown Facility

Rome, Lazio, 00168, Italy

Location

Unknown Facility

Genoa, Liguria, 16128, Italy

Location

Unknown Facility

Milan, Lombardy, 20132, Italy

Location

Unknown Facility

Milan, Lombardy, 20133, Italy

Location

Unknown Facility

Terni, Umbria, 05100, Italy

Location

Unknown Facility

Padua, Veneto, 35128, Italy

Location

Unknown Facility

Treviso, Veneto, 31100, Italy

Location

Related Publications (1)

• Brandes AA, Finocchiaro G, Zagonel V, Reni M, Caserta C, Fabi A, Clavarezza M, Maiello E, Eoli M, Lombardi G, Monteforte M, Proietti E, Agati R, Eusebi V, Franceschi E. AVAREG: a phase II, randomized, noncomparative study of fotemustine or bevacizumab for patients with recurrent glioblastoma. Neuro Oncol. 2016 Sep;18(9):1304-12. doi: 10.1093/neuonc/now035. Epub 2016 Mar 6.

  PMID: 26951379 DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Bevacizumab; fotemustine

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 18, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 15, 2016
• Results First Posted: August 7, 2015

Record last verified: 2015-09

Locations

IT (10)