Tivozanib for Recurrent Glioblastoma

NCT01846871 | Completed Phase 2 Results DMC

• 1 other identifier: 13-069
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the study drug tivozanib is still being studied. It also means that the FDA has not yet approved tivozanib for your type of cancer. Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking the blood supply to the tumor, so that the tumor does not receive the nutrients it requires to grow. In this research study, we are looking to see what effects, good and bad, tivozanib will have on you and your disease.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Number of Patients Alive and Progression Free After 6 Months

  To determine the number of patients with recurrent glioblastoma (GBM) alive and progression free 6 months (PFR6) after start of tivozanib therapy

  6 months

Secondary Outcomes (9)

• Number of Participants With Treatment Related Serious Adverse Events

  From the start of treatment until disease progression, unacceptable toxicity, or death; median duration of approximately 2 months

• Median Overall Survival

  From the start of treatment until the time of death, median duration of approximately 8 months

• Median Progression-Free Survival

  From the start of treatment until death or progression, median duration of approximately 2 months

• Best RANO Criteria Response

  2 years

• Steroid Dosage

  2 years

Study Arms (1)

Tivozanib

EXPERIMENTAL

1.5 mg daily for 3 weeks, with 1 week off.

Drug: Tivozanib

Interventions

Tivozanib DRUG

Also known as: AV-951

Tivozanib

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed glioblastoma that has progressed based on imaging or surgery
• Measurable disease
• No more than 3 prior chemotherapy regimens
• Must have recovered from toxicity of prior therapy. An interval of at least 3 months must have elapsed since the completion of the most recent course of radiotherapy; at least 3 weeks since last non-nitrosourea containing chemotherapy regimen or molecularly targeted agent; at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen
• Life expectancy of at least 12 weeks
• Able to tolerate MRIs
• Willing to use adequate, highly effective contraception measures while on study and for at least 45 days after the last dose of study drug

You may not qualify if:

• Pregnant or breastfeeding
• Major surgical procedure or significant traumatic injury within 28 days of starting therapy; or minor surgical procedure within 7 days
• Receiving other study agents
• Prior therapy with an anti-VEGF agent
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to tivozanib
• Receiving any medications or substances that are inhibitors or inducers of CYP450 enzymes
• Significant cardiovascular disease
• Non-healing wound, bone fracture or skin ulcer
• Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition with increased risk of perforation; abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
• Uncontrolled intercurrent illness
• Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug
• Significant bleeding disorders within 6 months prior to administration of first dose of study drug
• Currently active second primary malignancy
• HIV positive and on combination antiretroviral therapy
• Inability to swallow capsules, malabsorption syndrome or gastrointestinal disease that severely affects the absorption of study drugs, major resection of the stomach or small bowel, or gastric bypass procedure

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Comprehensive Cancer Network: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

tivozanib

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

Results Point of Contact

• Title: Dr. Elizabeth Gerstner
• Organization: Massachusetts General Hospital

EGERSTNER@mgh.harvard.edu

617-724-8770

Study Officials

• Elizabeth Gerstner, MD

  Massachusetts General Hospital

  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: May 1, 2013
• First Posted: May 3, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: May 1, 2016
• Last Updated: January 8, 2019
• Results First Posted: January 8, 2019

Record last verified: 2018-12

Locations

US (1)