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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Cancer, Thyroid Carcinoma

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Trial Information

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


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
- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Assessed during periodic visits

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

XL184-001

NCT ID:

NCT00215605

Start Date:

September 2005

Completion Date:

July 2012

Related Keywords:

  • Lymphoma
  • Cancer
  • Thyroid Carcinoma
  • Advanced Malignancies
  • Solid Tumor
  • Medullary Thyroid Cancer
  • Neoplasms
  • Carcinoma
  • Thyroid Neoplasms
  • Lymphoma
  • Thyroid Diseases

Name

Location

Johns Hopkins University Baltimore, Maryland  21205
Memorial Sloan Kettering Cancer Center New York, New York  10021
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
University of Chicago Chicago, Illinois  60637
Univ. of Texas MD Anderson Cancer Center Houston, Texas  77030