Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies

Trial ID or NCT#

NCT00215605

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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
Exclusion Criteria:
  1. - 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

Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

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Contact

Ruth Lira
6507231367