Phase I Combination Ixabepilone + Cisplatin

NCT00832117 | Completed Phase 1 Results

• 2 other identifiers: CA163-1772008-004909-34
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 7

Brief Summary

The purpose of this study is to determine the highest dose of ixabepilone that can be given safely with cisplatin without causing severe or life-threatening side effects and for some patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also be studied

Conditions

Non Small Cell Lung Cancer

Keywords

Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (2)

• Participants Experiencing Dose Limiting Toxicity (DLT)

  DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for \>3 weeks;Gr4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for \>=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever \>38.5°C;thrombocytopenia \<25,000 cells/mm\^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7.

  Within the first 21 days of first cycle

• Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2

  The MTD is defined as the highest dose level in which dose limiting toxicities (DLTs) during the first 21 days of the first treatment cycle are observed in less than 1 out of 3 or less than 2 out of 6 treated subjects with at least 2 subjects experiencing DLT at the next higher dose level.

  Within the first 21 days of first cycle

Secondary Outcomes (5)

• Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)

  At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.

• Percentage of Participants With Response

  At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.

• Duration of Response in Participants With Non-small Cell Lung Cancer (NSCLC)

  The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. (Duration of study was approximately 21 months.)

• Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria

  Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.

• Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria

  Assessed at screening and weekly during treatment. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.

Study Arms (1)

Escalation and Expansion

EXPERIMENTAL

Drug: Ixabepilone; Drug: Cisplatin

Interventions

Ixabepilone DRUG

Escalation: Solution, intravenous (IV), 32-40 mg/m2, every 3 weeks, approximately 6 months

Also known as: IXEMPRA®

Escalation and Expansion

Cisplatin DRUG

Escalation: Solution, IV, 60-100 mg/m2, every 3 weeks, approximately 6 months

Escalation and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age ≥ 18

You may not qualify if:

• More than 2 prior chemotherapy containing regimens for metastatic disease
• No prior exposure to cisplatin or ixabepilone
• Expansion Phase Subjects: Advanced Non-small cell lung cancer
• Men and women age ≥ 18
• No prior chemotherapy-containing regimen for metastatic disease
• No prior exposure to cisplatin or ixabepilone

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (7)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

The Cancer Institute Of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Local Institution

Lucca, 55100, Italy

Location

Local Institution

Meldola (Fc), 47014, Italy

Location

Local Institution

Rimini, 47900, Italy

Location

Local Institution

Viterbo, 01100, Italy

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

ixabepilone; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 29, 2009
• Study Start: May 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: October 28, 2020
• Results First Posted: March 27, 2012

Record last verified: 2020-10

Locations

IT (4); US (3)