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

R-Pharm35 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Malignancies

Interventions

IxabepiloneDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

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

Outcomes

Primary Outcomes

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.

Time frame: Measures taken at Cycle 01 (21-day cycle)

Secondary Outcomes

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).

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.

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).

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.

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.)

Data from ClinicalTrials.gov

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