Solid Malignancies Clinical Trial
Official title:
Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies
NCT number | NCT00162136 |
Other study ID # | CA163-085 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | September 2005 |
Est. completion date | July 2008 |
Verified date | February 2016 |
Source | R-Pharm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.
Status | Completed |
Enrollment | 35 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - confirmed diagnosis of a primary solid tumor - measurable or non-measurable disease - progressive disease - men and women greater or equal to 18 years of age. Exclusion Criteria: - women of child bearing potential who are not using birth control - women who are pregnant or breast feeding - women with a positive pregnancy test on enrollment - patients with brain metastasis - prior treatment with Ixabepilone - known history of human immunodeficiency virus (HIV) |
Country | Name | City | State |
---|---|---|---|
United States | University Of Maryland | Baltimore | Maryland |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | The Cancer Institute Of New Jersey | New Brunswick | New Jersey |
Lead Sponsor | Collaborator |
---|---|
R-Pharm |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Dose Limiting Toxicities at Dose Level | 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. | Measures taken at Cycle 01 (21-day cycle) | |
Secondary | Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation | 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). | 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. | |
Secondary | Hematology Results - Worst On-Study Grade | 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). | 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. | |
Secondary | Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level | 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.) | through 72 hours after start of infusion | |
Secondary | Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST) | 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. | 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. |
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