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

Solid Malignancies Clinical Trial

Official title:

Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162136
• Other study ID #: CA163-085
• Status: Completed
• Phase: Phase 1
• Start date: September 2005
• Est. completion date: July 2008

Study information

• Verified date: February 2016
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Neoplasms
• Solid Malignancies

Intervention

Drug:
• Ixabepilone
Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
R-Pharm

Country where clinical trial is conducted

United States, 

Outcome

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.