Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT00027677 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : July 24, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | December 7, 2001 | |||
First Posted Date ICMJE | January 27, 2003 | |||
Last Update Posted Date | July 24, 2012 | |||
Study Start Date ICMJE | August 2001 | |||
Actual Primary Completion Date | February 2004 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors | |||
Official Title ICMJE | Phase I Study To Determine The Safety Of Halofuginone In Patients With A Solid Progressive Tumor | |||
Brief Summary | RATIONALE: Halofuginone hydrobromide may stop the growth of solid tumors by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of halofuginone hydrobromide in treating patients who have progressive advanced solid tumors. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral halofuginone hydrobromide once daily on days 1 and 4-14 of course 1 and on days 1-14 of subsequent courses. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-3 patients receive escalating doses of halofuginone hydrobromide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 20% of patients experience acute dose-limiting toxicity. After the MTD is reached, 6-12 additional patients are treated at dose levels preceding the MTD until the recommended dose for phase II study is determined. The recommended dose for phase II study is defined as the dose preceding the MTD that allows a 90% dose intensity for 2 months with no greater than grade 2 toxicity in 80% of the patients. Patients are followed every 8 weeks until disease progression or initiation of another treatment. PROJECTED ACCRUAL: Approximately 7-40 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE | Unspecified Adult Solid Tumor, Protocol Specific | |||
Intervention ICMJE | Drug: halofuginone hydrobromide | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
25 | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | February 2004 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00027677 | |||
Other Study ID Numbers ICMJE | EORTC-16007 EORTC-16007 COLLGARD-EORTC-16007 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | European Organisation for Research and Treatment of Cancer - EORTC | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | European Organisation for Research and Treatment of Cancer - EORTC | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | European Organisation for Research and Treatment of Cancer - EORTC | |||
Verification Date | July 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |