Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.

Phase 1

Completed

• Conditions: Solid Malignancies
• Interventions: Drug: Ixabepilone

• Registration Number: NCT00162136
• Lead Sponsor: R-Pharm

Brief Summary

The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-07-03
• Results First Submitted QC: 2009-12-22
• Results First Posted: 2010-01-27
• Status Verified: 2016-02
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A1	Ixabepilone	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose Limiting Toxicities at Dose Level	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 Outcome Measures

Name	Time	Method
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.	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.
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.	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	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	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.)

Trial Locations

Locations (3)

University Of Maryland; 🇺🇸 Baltimore, Maryland, United States

The Cancer Institute Of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States