Dose/ Schedule Finding Trial of AMG 531 for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00413283
First received: December 15, 2006
Last updated: November 24, 2010
Last verified: November 2010
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Purpose
The purpose of this study is to identify an effective, well tolerated dose and schedule of AMG 531 (romiplostim) that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in subjects with non-small cell lung cancer receiving gemcitabine and platinum.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Chemotherapy-Induced Thrombocytopenia Non-small Cell Lung Cancer Cancer Lung Neoplasms Oncology Solid Tumors Thrombocytopenia |
Biological: AMG 531 (romiplostim) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Phase 2, Randomized, Double Blind, Placebo-Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 For Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Advanced Non-Small Cell Lung Cancer Already Receiving Gemcitabine and Platinum. |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Incidence of Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Participant incidence of adverse events
Secondary Outcome Measures:
- Duration of Grade 3 or 4 Thrombocytopenia [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]The duration of grade 3 or 4 thrombocytopenia (platelet count <50 x 10^9/L) experienced during the first on study chemotherapy cycle by treatment group
- Incidence of Participants Experiencing Grade 3 or 4 Thrombocytopenia (<50 x 10^9/L) During First Treatment Cycle [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]Incidence of participants in each treatment group grade 3 or 4 thrombocytopenia (<50 x 10^9/L) during first on study treatment cycle
- Participant Incidence of Platelet Transfusions [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]Incidence of participants who were administered platelet transfusions during first on study treatment cycle
- Platelet Count on Day 22 [ Time Frame: Day 22 ] [ Designated as safety issue: No ]Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group
- Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle [ Time Frame: 8 days ] [ Designated as safety issue: No ]Incidence of participants that required gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle
| Enrollment: | 63 |
| Study Start Date: | December 2006 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Cohort 01: Placebo
Placebo: 250 µg Dose Level
|
Drug: Placebo
Subjects in the control group will be administered a placebo once per 21 day chemotherapy cycle by subcutaneous injection.
|
|
Placebo Comparator: Cohort 02: Placebo
Placebo: 500 µg Dose Level
|
Drug: Placebo
Subjects in the control group will be administered a placebo once per 21 day chemotherapy cycle by subcutaneous injection.
|
|
Placebo Comparator: Cohort 03: Placebo
Placebo: 750 µg Dose Level
|
Drug: Placebo
Subjects in the control group will be administered a placebo once per 21 day chemotherapy cycle by subcutaneous injection.
|
|
Experimental: Cohort 01: AMG 531 (romiplostim)
AMG 531 (romiplostim): 250 µg Dose Level
|
Biological: AMG 531 (romiplostim)
AMG 531 (romiplostim) is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 (romiplostim) will be administered once per chemotherapy 21 day cycle by subcutaneous injection.
|
|
Experimental: Cohort 02: AMG 531 (romiplostim)
AMG 531(romiplostim): 500 µg Dose Level
|
Biological: AMG 531 (romiplostim)
AMG 531 (romiplostim) is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 (romiplostim) will be administered once per chemotherapy 21 day cycle by subcutaneous injection.
|
|
Experimental: Cohort 03: AMG 531 (romiplostim)
AMG 531 (romiplostim): 750 µg Dose Level
|
Biological: AMG 531 (romiplostim)
AMG 531 (romiplostim) is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 (romiplostim) will be administered once per chemotherapy 21 day cycle by subcutaneous injection.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced or metastatic stage IIIB or stage IV NSCLC receiving Q21 day gemcitabine/carboplatin or gemcitabine/cisplatin
- Life expectancy > or = 12 weeks at the time of screening
- Thrombocytopenia as evidenced by a platelet count < or = 50 x 10^9/L during the qualifying cycle of chemotherapy, OR platelet count < 100 x 10^9/L on Day 22 of the qualifying cycle (for eligibility inclusion: ability to receive the same dose of chemotherapy on study), this criteria ensures that the subject must be dose delayed for platelet recovery
- Ability to receive the same dose and schedule of chemotherapy during the first on-study treatment cycle as was given in the qualifying cycle (except Day 8 gemcitabine)
- ANC > or = 1,000/µL, Hgb > or = 9.5 g/dL, and platelet count > or = 100 x 10 ^9/L on Day 1 of the first on study chemotherapy treatment cycle
- ECOG performance status of 0 to 2 at the time of screening
- Adequate Liver function; AST and ALT < 3.0 x ULN (except for subjects with a confirmed diagnosis of Gilbert's Syndrome)
- Adequate renal function; serum creatinine < 1.5 x ULN
Exclusion Criteria:
- Receipt of > 1 prior systemic chemotherapy regimen
- Sepsis, disseminated coagulation or any other condition (i.e. ITP, TTP, HUS) that may exacerbate thrombocytopenia
- History of unstable angina, CHF, uncontrolled hypertension (diastolic > 100mmHG), uncontrolled cardiac arrhythmia, or recent (within 1 year of screening ) MI
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1 year of screening
- History of pulmonary embolism or other venous thrombosis within 1 year of screening (except for catheter-related clots)
- Use of any nitrosourea or mitomycin-C within 6 weeks of screening
- Have received any thrombopoietic growth factor or related substance
- Have received granulocyte macrophage colony stimulating factor (GM-CSF) within the last 4 weeks prior to screening
- Have received any experimental therapy within 4 weeks prior to screening
- Have ever received a bone marrow or peripheral blood stem cell infusion (within 1 year of screening)
- Known hypersensitivity to any recombinant E. coli-derived product
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413283
Show 55 Study Locations
Show 55 Study LocationsSponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00413283 History of Changes |
| Other Study ID Numbers: | 20050154 |
| Study First Received: | December 15, 2006 |
| Results First Received: | September 24, 2010 |
| Last Updated: | November 24, 2010 |
| Health Authority: | Austria: Secretariat of Health Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: Ministry of Health Portugal: National Institute of Pharmacy and Medicines United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Advanced Non-Small Cell Lung Cancer Chemotherapy Induced Thrombocytopenia CIT NSCLC Stage IIIB NSCLC |
Stage IV NSCLC Gemcitabine Carboplatin Cisplatin |
Additional relevant MeSH terms:
|
Lung Neoplasms Neoplasms Carcinoma, Non-Small-Cell Lung Thrombocytopenia Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Blood Platelet Disorders Hematologic Diseases Gemcitabine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 16, 2013