Japanese Study of Ipilimumab in Combination With Paclitaxel/Carboplatin
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01165216
First received: July 16, 2010
Last updated: June 18, 2012
Last verified: February 2012
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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 ]
| Estimated Enrollment: | 15 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 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
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 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: | June 18, 2012 |
| 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 May 21, 2013