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A Broad Multi-histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-small Cell Lung, Head and Neck Hepatocellular and Renal Cell Carcinomas, and Pheochromocytoma and Thyroid Tumors (Multi-H...

NCT00923481 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2015-09-30

Study results available
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Summary

Background:

* The drug R935788 (fostamatanib disodium) is a kinase inhibitor (i.e., it interferes with cell communication and growth and may prevent tumor growth).
* R935788 has shown promising activity in NCI-60 (a panel of 60 diverse human cancer cell lines) against colon cancer, non-small cell lung cancer, and renal cell carcinoma cell lines, as well as in two renal cell xenograft models.
* This is an open-label, Phase II study of R935788. Phase I studies in patients with immune thrombocytopenic purpura, rheumatoid arthritis, and lymphoma have demonstrated safety with a continuous dosing schedule, and a maximum tolerated dose has been established.

Objectives:

* To test an experimental drug called R935788 (fostamatinib disodium) for its ability to stop cancer growth signals, thus slowing the growth of cancer cells in laboratory testing.
* To determine the clinical response of R935788 administered orally twice a day on a continuous schedule in patients with colorectal carcinoma, pheochromocytoma, follicular or papillary thyroid cancer, non-small cell lung cancer, hepatocellular, carcinoma of the head and neck, and renal cell carcinoma.
* To evaluate the effects, safety, and biochemical response of R935788 therapy.

Eligibility:

* Patients with colorectal carcinoma, pheochromocytoma, follicular or papillary thyroid cancer, non-small cell lung cancer (excluding squamous cell histology), hepatocellular cancer, carcinoma of the head and neck, and renal cell carcinoma whose disease has progressed after any therapy or who have no acceptable standard treatment options.
* Patients must have recovered from toxicities of prior therapies to at least eligibility levels.
* Patients who have received radiation or chemotherapy within 4 weeks of study enrollment are not eligible.
* Women who are pregnant or breastfeeding are not eligible.

Design:

* Researchers will conduct the following tests and procedures during the study:

* Clinic visits with a physical exam, including vital signs and blood pressure, every other week during cycle 1, and once a month starting with cycle 2.
* Blood will be drawn weekly during cycle 1, every other week during cycle 2, and once a month starting with cycle 3; urine tests will be conducted depending on results of blood tests.
* Imaging tests, such as computed tomography (CT) scans (a series of x-rays) or ultrasound (an examination using sound waves), will be done every 8 weeks while the patient is receiving R935788.
* R935788 will be administered orally twice a day for 28 days (one cycle). Imaging studies will be obtained every two cycles. Patients will fill in a diary to show when they took the medication and to note any side effects. The 28-day treatment cycle will be repeated as long as the patient is tolerating R935788 and the cancer is either stable or getting better.
* Researchers will conduct the following additional tests to see how the study is affecting the patient:

* Other research blood samples will be collected before treatment, at cycle 1 week 3, at the beginning of cycle 2, and at 8 weeks.
* Optional tumor biopsies will be requested before starting treatment, at cycle 1 day 28.
* Patients with specific lesions or tumors may be asked for an optional tumor biopsy on day 8.

Conditions

  • Head and Neck Neoplasms
  • Pheochromocytoma
  • Colorectal Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell

Interventions

DRUG

Fostamatinib disodium

200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Shivaani Kummar, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-04-30
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00923481 on ClinicalTrials.gov