Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01860638 : A Comparison of Continuous Bevacizumab (Avastin) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Participants With Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Adult participants greater than or equal to (>=) 18 years of age

- Newly diagnosed, histologically confirmed glioblastoma not previously treated with
chemotherapy or radiotherapy

- If female and not postmenopausal (less than [<] 12 months of amenorrhea) or
surgically sterile, must agree to use a highly effective contraceptive method during
the treatment period and for at least 6 months after the last dose of study drug

- Karnofsky performance status (KPS) >= 60

- Mandatory tissue collection during pre-study surgery or biopsy for confirmation of
the diagnosis and pathology

- Craniotomy or intracranial biopsy site must be adequately healed. Study treatment
should be initiated > 28 days following the last surgical procedure

Principal eligibility criteria at the time of randomization (following PD1)

- Documented disease progression

- Eligibility for 2nd-line treatment with lomustine and bevacizumab as investigational
medicinal products

- Patients for whom operation or re-operation is indicated before 2nd-line treatment
starts, tissue submission is mandatory

- Eastern Cooperative Oncology Group (ECOG) performance status is 0-2 when starting
2nd-line treatment

- Bevacizumab was well tolerated and treatment interruption lasted not more than 60
days

Exclusion Criteria:

- Any prior chemotherapy for glioblastoma and low grade astrocytomas

- Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential
overlap in the radiation field

- Prior or current anti-angiogenic treatment

- Treatment with any other investigational drug within 28 days or 2 investigational
agent half-lives (whichever is longer) prior to first study treatment

- Inadequate hematological, renal or liver function

- Inadequately controlled hypertension

- Prior history of gastrointestinal perforation or abscess

- Clinically significant cardiovascular disease, New York Heart Association (NYHA) >=
Grade II congestive heart failure, or serious cardiac arrhythmia uncontrolled by
medication or potentially interfering with protocol treatment

- History or evidence of central nervous system disease unrelated to cancer unless
adequately treated with standard medical therapy

- History or evidence of inherited bleeding diathesis or significant coagulopathy at
risk of bleeding

- Serious non-healing wound, active ulcer, or untreated bone fracture

- Known hypersensitivity to any component of Avastin/placebo or any of the study drugs

- Active infection requiring intravenous antibiotics at start of study treatment

- Other malignancy within 5 years prior to study enrollment, except for carcinoma in
situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or
ductal carcinoma in situ treated with curative intent

- Pregnant or lactating women

- Participation in any other study
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01860638      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2019 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740