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Completed

NCT Number: NCT00215605

Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies

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.

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Key information

Conditions

Lymphoma Adenocarcinoma Cancer Carcinoma Carcinoma, Medullary Carcinoma, Neuroendocrine Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Thyroid Carcinoma Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Chicago, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XL184

Drug

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 outcomes

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

    Time frame: Assessed during periodic visits

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

    Time frame: Assessed during periodic visits

Secondary outcomes

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

    Time frame: Assessed during periodic visits

  2. Evaluate preliminary tumor response after repeated XL184 administration

    Time frame: Assessed during periodic visits

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

    Time frame: Assessed during periodic visits

Sponsors and collaborators

Lead sponsor

Exelixis

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2012
First posted
Sep 22, 2005
Registry last updated
Feb 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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