Study of Multiple Doses and Regimens of XL184 (Cabozantinib) in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse

NCT ID: NCT01068782

Last Updated: 2014-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-10-31

Brief Summary

This is a study of multiple regimens of single-agent XL184 in subjects with grade IV astrocytic tumor in first or second relapse. The Randomized Phase of the study will evaluate the safety, tolerability, and preliminary efficacy of four XL184 dosing regimens in separate study arms. Subjects will be randomized to one of the study arms, which will not be blinded. After the Randomized Phase, additional subjects will be enrolled to further expand one study arm in the Expansion Phase.

Conditions

Astrocytic Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

XL184

Intervention Type: DRUG

given orally as capsules

Arm 2

Group Type: EXPERIMENTAL

XL184

Intervention Type: DRUG

given orally as capsules

Arm 3

Group Type: EXPERIMENTAL

XL184

Intervention Type: DRUG

given orally as capsules

Arm 4

Group Type: EXPERIMENTAL

XL184

Intervention Type: DRUG

given orally as capsules

Interventions

XL184

given orally as capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The subject has histologically confirmed diagnosis at any time of grade IV astrocytic tumor as determined by the investigator. Tumor samples will be required for pathology review.
• The subject has received prior standard radiation for any grade astrocytic tumor.
• The subject has received prior temozolomide (Temodar) therapy
• The subject has had one or two progressions as grade IV astrocytic tumor from any grade, as determined by investigator
• The subject must have a qualifying brain MRI scan within a specific timeframe prior to start of study treatment
• For subjects with recent tumor resection or biopsy, starting on study must occur a specified amount of time after the surgery and the subject must have recovered from the effects of surgery
• The subject has a Karnofsky Performance Status ≥ 70% and has the ability to swallow whole capsules
• The subject is capable of understanding the informed consent and has signed the informed consent document
• The subject has adequate organ and marrow function
• Sexually active subjects (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 6 months following discontinuation of study treatment
• The subject has had no other diagnosis of malignancy (certain exceptions apply)
• Female subjects of childbearing potential must have a negative pregnancy test at screening

Exclusion Criteria

• The subject has received certain prior anticancer therapies within a certain amount of time before starting study treatment
• The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin
• The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or CT scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible
• The subject is unable to undergo MRI scan (eg, has pacemaker)
• The subject has received enzyme-inducing anti-epileptic agents within a certain time prior to starting study treatment (eg, carbamazepine, phenytoin, phenobarbital, primidone)
• The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤ 1 from AEs (except alopecia and lymphopenia) due to surgery, or other medications that were administered prior to study start
• The subject has evidence of unhealed wounds
• The subject is pregnant or breast-feeding
• The subject has serious intercurrent illness or a recent history of serious disease
• The subject has inherited bleeding diathesis or coagulopathy (disease affecting how blood clots) with the risk of bleeding
• The subject has a history of any medical or surgical conditions (eg, stomach or intestinal surgery or resection) that would potentially interfere with or alter gastrointestinal function
• The subject has a history of idiopathic pulmonary fibrosis or interstitial lung disease
• The subject has received any live virus vaccine or any inactivated vaccine within a certain amount of time before starting study treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Exelixis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham, Alabama, United States

Encinitas, California, United States

Pleasant Hill, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Minneapolis, Minnesota, United States

Amhearst, New York, United States

Rochester, New York, United States

Cleveland, Ohio, United States

Hershey, Pennsylvania, United States

Dallas, Texas, United States

Dallas, Texas, United States

San Antonio, Texas, United States

Charlottesville, Virginia, United States

Seattle, Washington, United States

Calgary, Alberta, Canada

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

XL184-205

Identifier Type: -

Identifier Source: org_study_id