Dose/ Schedule Finding Trial of AMG 531 for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00413283

Purpose

The purpose of this study is to identify an effective, well tolerated dose and schedule of AMG 531 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
Solid Tumors Thrombocytopenia Lung Cancer Chemotherapy-Induced Thrombocytopenia Non-Small Cell Lung Cancer Cancer Lung Neoplasms Oncology	Biological: AMG 531 Drug: Placebo	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gemcitabine AMG 531

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Amgen:

Primary Outcome Measures:

Incidence of adverse events and the incidence of anti-AMG 531 antibody formation by treatment group. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of subjects in each treatment group grade 3 or 4 thrombocytopenia (<50 x 10^9/L) during first on study treatment cycle [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Incidence of subjects who are administered platelet transfusions during first on study treatment cycle [ Time Frame: 24 months ] [ 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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Incidence of subjects that require gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle [ Time Frame: 24 months ] [ Designated as safety issue: No ]
The duration of grade 3 or 4 thrombocytopenia experienced during the first on study chemotherapy cycle by treatment group [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment:	95
Study Start Date:	December 2006
Study Completion Date:	February 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 01: Placebo: Placebo Comparator 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.
Cohort 02: Placebo: Placebo Comparator 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.
Cohort 03: Placebo: Placebo Comparator 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.
Cohort 06: AMG 531: Experimental Optional Cohort 06, Cohort Expansion, AMG 531: Dose To Be Determined	Biological: AMG 531 AMG 531 is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 will be administered once per chemotherapy 21 day cycle by subcutaneous injection.
Cohort 04: AMG 531: Experimental Optional Cohort 04, New Schedule, AMG 531: Dose Level To Be Determined	Biological: AMG 531 AMG 531 is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 will be administered once per chemotherapy 21 day cycle by subcutaneous injection.
Cohort 05: AMG 531: Experimental Optional Cohort 05, New Dose, AMG 531: Dose To Be Determined	Biological: AMG 531 AMG 531 is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 will be administered once per chemotherapy 21 day cycle by subcutaneous injection.
Cohort 06: Placebo: Placebo Comparator Optional Cohort 06, Cohort Expansion, Placebo: Dose To Be Determined	Drug: Placebo Subjects in the control group will be administered a placebo once per 21 day chemotherapy cycle by subcutaneous injection.
Cohort 02: AMG 531: Experimental AMG 531: 500 µg Dose Level	Biological: AMG 531 AMG 531 is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 will be administered once per chemotherapy 21 day cycle by subcutaneous injection.
Cohort 04: Placebo: Placebo Comparator Optional Cohort 04, New Schedule, Placebo: Dose To Be Determined	Drug: Placebo Subjects in the control group will be administered a placebo once per 21 day chemotherapy cycle by subcutaneous injection.
Cohort 05: Placebo: Placebo Comparator Optional Cohort 05, New Dose, Placebo: Dose To Be Determined	Drug: Placebo Subjects in the control group will be administered a placebo once per 21 day chemotherapy cycle by subcutaneous injection.
Cohort 01: AMG 531: Experimental AMG 531: 250 µg Dose Level	Biological: AMG 531 AMG 531 is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 will be administered once per chemotherapy 21 day cycle by subcutaneous injection.
Cohort 03: AMG 531: Experimental AMG 531: 750 µg Dose Level	Biological: AMG 531 AMG 531 is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. AMG 531 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

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050154
Study First Received:	December 15, 2006
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00413283 History of Changes
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

Study placed in the following topic categories:

Thoracic Neoplasms
Hematologic Diseases
Blood Platelet Disorders
Carboplatin
Carcinoma
Signs and Symptoms
Thrombocytopathy
Thrombocytopenia

Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Hematologic Diseases
Blood Platelet Disorders
Carcinoma
Neoplasms

Thrombocytopenia
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009