Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

XL184

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Advanced Malignancies, Solid Tumor, Medullary Thyroid Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed advanced malignancy (solid tumor or lymphoma) that is metastatic or unresectable for which standard curative measures do not exist or are no longer effective Eastern Cooperative Oncology Group (ECOG) performance status </= 2 Life expectancy greater than 3 months Adequate organ and marrow function Written informed consent Use of acceptable methods of contraception during the course of the study and for 3 months after completion of study In the MTD expanded cohort: at least 20 subjects with metastatic and/or advanced/locally recurrent Medullary Thyroid Cancer not appropriate for surgical resection with measurable disease as defined by RECIST Exclusion Criteria: Chemotherapy, immunotherapy or radiation within 4 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first scheduled dose of XL184 Administration of an investigational drug within 30 days of the first dose of XL184 Subject has not recovered from adverse events due to investigational agents or other medications administered more than 4 weeks before study enrollment Known brain metastases Uncontrolled intercurrent illness Pregnancy or breastfeeding Known HIV positive Known allergy or hypersensitivity to any of the components of the XL184 formulation

Sites / Locations

University of Chicago
Johns Hopkins University
Memorial Sloan Kettering Cancer Center
Fox Chase Cancer Center
Univ. of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Safety, tolerability, maximum tolerated dose (MTD), and dose-limiting toxicity of oral administration of XL184

Evaluate plasma pharmacokinetics and estimate renal elimination of oral administration of XL184

Secondary Outcome Measures

Long-term safety/tolerability of XL184 after oral administration for up to 1 year

Evaluate preliminary tumor response after repeated XL184 administration

In MTD expanded cohort: Progression-free survival and duration of response in subjects with advanced or recurrent medullary thyroid cancer

Full Information

NCT ID

NCT00215605

First Posted

September 20, 2005

Last Updated

February 26, 2013

Sponsor

Exelixis

1. Study Identification

Unique Protocol Identification Number

NCT00215605

Brief Title

Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies

Official Title

A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL184 Administered Orally to Subjects With Advanced Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Exelixis

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine the best and safest dose of XL184 administered orally. XL184 is a new chemical entity that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration. To determine the highest safe dose, subjects will receive different amounts of the drug. The first group of subjects will receive the lowest dose of XL184. As long as no medically unacceptable side effects are noted, the dose will be increased for the next group. When the maximum tolerated dose (MTD) is reached, at least 20 subjects with Medullary Thyroid Cancer (MTC) will be enrolled to evaluate the effect of XL184 in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Cancer, Thyroid Carcinoma

Keywords

Advanced Malignancies, Solid Tumor, Medullary Thyroid Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

XL184

Intervention Description

Flavored liquid suspension or gelatin capsules supplied in 25-mg and 100-mg strengths; daily dosing or intermittent schedule (daily dosing followed by dosing holiday in cycles)

Primary Outcome Measure Information:

Title

Safety, tolerability, maximum tolerated dose (MTD), and dose-limiting toxicity of oral administration of XL184

Time Frame