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Brief Title † | CC-4047 in Treating Patients With Advanced Solid Tumors That Did Not Respond to Treatment | ||||
Official Title † | A Phase I, Open-Label Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety Profile of CC-4047 in Subjects With Advanced Solid Tumors | ||||
Brief Summary | RATIONALE: CC-4047 may stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of CC-4047 in treating patients with advanced solid tumors that did not respond to treatment. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a open-label, uncontrolled, nonrandomized, dose-escalation, multicenter study.
Cohorts of 3-6 patients receive escalating doses of CC-4047 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). Patients with no clinical evidence of progressive disease or DLT after course 1 continue study treatment during the extension phase. Patients who develop a DLT during course 1 may continue study treatment at the discretion of the investigator.
Patients undergo blood collection at baseline and periodically during study to evaluate fetal hemoglobin levels. After completion of study treatment, patients are followed at 28 days. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled | ||||
Primary Outcome Measure † | Maximum tolerated dose [ Designated as safety issue: Yes ] Dose-limiting toxicity [ Designated as safety issue: Yes ] |
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Secondary Outcome Measure † | Tumor response as assessed by RECIST criteria after every 2 courses [ Designated as safety issue: No ] Duration of response [ Designated as safety issue: No ] Safety and tolerability [ Designated as safety issue: Yes ] Fetal hemoglobin levels as assessed at baseline and every 28 days thereafter [ Designated as safety issue: No ] |
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Condition † | Unspecified Adult Solid Tumor, Protocol Specific | ||||
Intervention † | Drug: CC-4047 | ||||
MEDLINE PMIDs | |||||
Links | Clinical trial summary from the National Cancer Institute's PDQ® database  | ||||
Recruitment Information Fields | |||||
Recruitment Status † | Suspended | ||||
Enrollment † | 36 | ||||
Start Date † | March 2007 | ||||
Completion Date | |||||
Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00482521 | ||||
Organization ID | CDR0000547260 | ||||
Secondary IDs †† | CASE-4Y06 | ||||
Study Sponsor † | Case Comprehensive Cancer Center | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | February 2009 | ||||
First Received Date † | June 4, 2007 | ||||
Last Updated Date | February 7, 2009 |