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

Ixabepilone

Bristol-Myers Squibb

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

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

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

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.

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).

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 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.)

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.

R-Pharm

Study Director

Ixa 10 mg/m2

Ixa 20 mg/m2

Ixa 30 mg/m2

Ixa 35 mg/m2

Ixa 40 mg/m2

Ixa 45 mg/m2

10 mg/m2

20 mg/m2

30 mg/m2

35 mg/m2

40 mg/m2

45 mg/m2

Total

Age, Continuous

Sex: Female, Male

White

Black

Asian

Race/Ethnicity, Customized

90 to 100

70 to 80

0 to 60

The Karnofsky Performance Status (KPS) measures the ability of cancer patients to perform ordinary tasks. Scores are reported in multiples of 10 and range from 0 to 100; a higher score means the patient is better able to carry out daily activities.

Karnofsky Performance Status

Bristol-Myers Squibb Study Director

Number of Participants With Dose Limiting Toxicities at Dose Level

Any Treatment-Related AE

Nausea

Fatigue

Alopecia

Diarrhea

Peripheral sensory neuropathy

Stomatitis

Any SAE

Death within 30 days of last dose

Any AE leading to discontinuation

Grade 1/2

Grade 3=Severe, Grade 4=Life-threatening or disabling

Grade 3/4

All Grades

Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation

White Blood Cells

Absolute Neutrophil Count

Hemoglobin

Platelets

Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

Hematology Results - Worst On-Study Grade

Hour 0.00 (n=11)

Hour 1.00 (n=11)

Hour 2.00 (n=11)

Hour 4.00 (n=11)

Hour 8.00 (n=11)

Hour 12.00 (n=11)

Hour 16.00 (n=11)

Hour 20.00 (n=11)

Hour 24.00 (n=11)

Hour 25.00 (n=10)

Hour 26.00 (n=10)

Hour 27.00 (n=10)

Hour 72.00 (n=10)

All treated subjects with measurement at timepoint

Treated Subjects

All participants treated at the 40 mg/m2 dose level.

Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level

Complete Response

Partial Response

Stable Disease

Progressive Disease

Unable to Determine

All Treated Participants

Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)

Overall Study

Spots Global Cancer Trial Database for Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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