Japanese Study of Ipilimumab in Combination With Paclitaxel/Carboplatin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01165216
First received: July 16, 2010
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

The primary purpose is to establish the recommended dose of ipilimumab in combination with paclitaxel and carboplatin in Japanese subjects with Non-Small Cell Lung Cancer (NSCLC).


Condition Intervention Phase
Non-Small Cell Lung Cancer
Biological: Ipilimumab
Biological: Paclitaxel
Biological: Carboplatin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Ipilimumab (BMS-734016) in Combination With Paclitaxel and Carboplatin in Japanese Patients With Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Recommended dose of ipilimumab in combination with paclitaxel and carboplatin [ Time Frame: From Day 1 at 3rd cycle to Day 21 at 4th cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma PK: Summary stats tabulated for PK parameters (Cmax, AUC(0-21d), Tmax, & T-HALF) by ipilimumab dose. Geometric mean & coefficient of variation for Cmin tabulated by dose & time. Geometric mean plots of Cmin vs. time provided for each dose level [ Time Frame: Induction period: Cycle 3: Day 1-3, 8, 15 ] [ Designated as safety issue: No ]
  • Plasma PK: Summary stats tabulated for PK parameters (Cmax, AUC(0-21d), Tmax, & T-HALF) by ipilimumab dose. Geometric mean & coefficient of variation for Cmin tabulated by dose & time. Geometric mean plots of Cmin vs. time provided for each dose level [ Time Frame: Induction period: Cycle 4-6: Day 1 ] [ Designated as safety issue: No ]
  • Tumor response: Individual tumor Best Overall Responses by RECIST criteria version 1.1 will be listed for each dose level [ Time Frame: Induction period: Every 6 weeks ] [ Designated as safety issue: Yes ]
  • Tumor response: Individual tumor Best Overall Responses by RECIST criteria version 1.1 will be listed for each dose level [ Time Frame: Maintenance period: Every 12 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity: A listing of immunogenicity data from subjects with at least one positive HAHA at any time point provided. The frequency of subjects with at least one positive HAHA outcome and frequency of neutralizing anti-ipilimumab antibodies provided [ Time Frame: Induction period: Cycle 3-6: Day 1 ] [ Designated as safety issue: Yes ]
  • Immunogenicity: A listing of immunogenicity data from subjects with at least one positive HAHA at any time point provided. The frequency of subjects with at least one positive HAHA outcome and frequency of neutralizing anti-ipilimumab antibodies provided [ Time Frame: Maintenance period: Pre-infusion every cycle ] [ Designated as safety issue: Yes ]
  • Immunogenicity: A listing of immunogenicity data from subjects with at least one positive HAHA at any time point provided. The frequency of subjects with at least one positive HAHA outcome and frequency of neutralizing anti-ipilimumab antibodies provided [ Time Frame: Off treatment ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: September 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab (BMS-734016)

Induction Period: Ipilimumab + Paclitaxel + Carboplatin

Maintenance Period: Ipilimumab

Biological: Ipilimumab
Injection, Intervenous, Induction Period: 3 mg/kg or 10 mg/kg, every 3 weeks, up to 6 cycles
Other Name: BMS-734016
Biological: Ipilimumab
Injection, Intravenous, 3 mg/kg or 10 mg/kg, every 12 weeks, until disease progression or unacceptable toxicity become apparent
Other Name: BMS-734016
Biological: Paclitaxel
Injection, Intravenous, 175 mg/m², Every 3 weeks, up to 6 cycles
Biological: Carboplatin
Injection, Intravenous, AUC 6, every 3 weeks, up to 6 cycles

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Histologically or cytologically documented NSCLC who present with stage IIIB without indications for definitive radiotherapy or stage IV or recurrent
  • No prior chemotherapy, hormonal therapy, immunotherapy and targeted therapy containing regimens for the treatment of NSCLC
  • Life expectancy of at least 3 months
  • Eastern Cooperative Oncology Group performance 0-1

Exclusion Criteria:

  • Symptomatic central nervous system (CNS) metastasis, or active CNS metastasis requiring medication.
  • Malignant body cavity fluid (e.g. pleural effusion, cardiac effusion, ascites) that is recurrent despite appropriate supportive care.
  • Autoimmune disease: subjects with a documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressant treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165216

Locations
Japan
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01165216     History of Changes
Other Study ID Numbers: CA184-113
Study First Received: July 16, 2010
Last Updated: February 10, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014