Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.
|ClinicalTrials.gov Identifier: NCT00162136|
Recruitment Status : Completed
First Posted : September 13, 2005
Results First Posted : January 27, 2010
Last Update Posted : March 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Solid Malignancies||Drug: Ixabepilone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
Other Name: IXEMPRA®
- Number of Participants With Dose Limiting Toxicities at Dose Level [ Time Frame: Measures taken at Cycle 01 (21-day cycle) ]Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for >14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia <25,000 cells/mm3 or bleeding requiring a platelet transfusion.
- Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation [ Time Frame: From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities. ]Adverse events (AEs) and Serious AEs (SAEs) considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).
- Hematology Results - Worst On-Study Grade [ Time Frame: Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution. ]Worst on-study grade based on laboratory values graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).
- Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level [ Time Frame: through 72 hours after start of infusion ]Mean concentrations over full time period for the 40 mg/mg2 dose level, established as the Maximum Tolerated Dose. (The Maximum Tolerated Dose was established as 40 mg/m2, based on an investiagtion of Dose Limiting Toxicities, which consisted of Febrile Neutropenia (at 40 mg/m2) in 1 participant and Grade 4 neutropenia lasting ≥5 days (at 45 mg/m2)in 2 participants.)
- Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles. ]RECIST criteria, wherein complete response = disappearance of all target lesions; partial response = 30% decrease in the sum of the longest diameter of target lesions; progressive disease = 20% increase in the sum of the longest diameter of target lesions, and stable disease = small changes that do not meet above criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162136
|United States, Maryland|
|University Of Maryland|
|Baltimore, Maryland, United States, 21201|
|United States, New Jersey|
|The Cancer Institute Of New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|