Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients

NCT01508117 | Terminated Phase 2 Results DMC

• 1 other identifier: UCCR-2
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the addition of an investigational medication, axitinib, to radiation therapy will improve the outcome of treatment in patients, above the age of 70.

Conditions

Glioblastoma Multiforme

Keywords

GBM; brain tumor

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  average 1 year

Study Arms (1)

Axitinib + Radiation Therapy

EXPERIMENTAL

Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity

Drug: Axitinib; Radiation: Radiation Therapy

Interventions

Axitinib DRUG

5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity

Also known as: AG-013736

Axitinib + Radiation Therapy

Radiation Therapy RADIATION

45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy

Also known as: Hypofractionated radiation therapy

Axitinib + Radiation Therapy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Newly diagnosed patients with histologically proven glioblastoma multiforme
• Age above 70 years
• Karnofsky score of 50-80
• Adequate organ function as defined by laboratory values
• Life expectancy of \>12 weeks
• No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be 140 mm Hg, and the baseline diastolic blood pressure readings must be 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.

You may not qualify if:

• Prior treatment with chemotherapy or radiation for glioblastoma multiforme
• Patients with extensive tumor hemorrhage
• Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism

Sponsors & Collaborators

• University of Cincinnati: lead
• Pfizer: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0502, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

Axitinib; Radiotherapy

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; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Limitations and Caveats

Early termination due to lack of accrual.

Results Point of Contact

• Title: Alison Kastl
• Organization: University of Cincinnati

kastla@ucmail.uc.edu

513-584-0436

Study Officials

• Rekha Chaudhury, MD

  University of Cincinnati

  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: Adjunct Assistant Professor

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 11, 2012
• Study Start: August 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 19, 2017
• Results First Posted: September 19, 2017

Record last verified: 2014-12

Locations

US (1)