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NCT00923481 · ClinicalTrials.gov registry record · Phase 2

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...

A Phase 2 study of Carcinoma, Non-Small Cell Lung and Colorectal Neoplasms, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
37
Enrollment target
1
Study location

NCT00923481 is a Phase 2 study of Carcinoma, Non-Small Cell Lung and Colorectal Neoplasms that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00923481, a Phase 2 study of Carcinoma, Non-Small Cell Lung and Colorectal Neoplasms, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
37 participants
Enrollment target
1
Study location

Study 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

Interventions

  • DRUG Fostamatinib disodium

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2009-04
Est. Completion 2012-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00923481

The ClinicalTrials.gov registry entry for NCT00923481 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (89% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 1 intervention - of which Fostamatinib disodium is the first listed.

NCT00923481 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00923481 about?

NCT00923481 is a clinical study titled "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...". 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 l...

What is the current status of trial NCT00923481?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2009-04. Estimated completion is 2012-01.

What conditions does trial NCT00923481 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung, Colorectal Neoplasms, Carcinoma, Renal Cell, Head and Neck Neoplasms, Pheochromocytoma.

What interventions are being tested in trial NCT00923481?

The interventions under investigation include: Fostamatinib disodium (DRUG).

Who is sponsoring clinical trial NCT00923481?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00923481 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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