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Completed

NCT Number: NCT00162136

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

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

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Key information

Conditions

Solid Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Of Maryland, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ixabepilone

Drug

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

Other names: IXEMPRA®

Primary outcomes

  1. 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

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

    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.

    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).

  2. Hematology Results - Worst On-Study Grade

    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.

    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).

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

    Time frame: 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.)

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

R-Pharm

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 13, 2005
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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