Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 3
- Primary Endpoint
- Number of Participants With Dose Limiting Toxicities at Dose Level
Study Overview
Brief Summary
The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
A1
Intervention: Ixabepilone (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)(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.)
- Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation(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.)
- Hematology Results - Worst On-Study Grade(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.)
- Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level(through 72 hours after start of infusion)