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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Chemotherapy-Induced Thrombocytopenia, Non-small Cell Lung Cancer, Cancer, Lung Neoplasms, Oncology, Solid Tumors, Thrombocytopenia

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Trial Information

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.


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/┬ÁL, 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Incidence of Adverse Events

Outcome Description:

Participant incidence of adverse events

Outcome Time Frame:

4 months

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Austria: Secretariat of Health

Study ID:

20050154

NCT ID:

NCT00413283

Start Date:

December 2006

Completion Date:

February 2009

Related Keywords:

  • Lung Cancer
  • Chemotherapy-Induced Thrombocytopenia
  • Non-Small Cell Lung Cancer
  • Cancer
  • Lung Neoplasms
  • Oncology
  • Solid Tumors
  • Thrombocytopenia
  • Advanced Non-Small Cell Lung Cancer
  • Chemotherapy Induced Thrombocytopenia
  • CIT
  • NSCLC
  • Stage IIIB NSCLC
  • Stage IV NSCLC
  • Gemcitabine
  • Carboplatin
  • Cisplatin
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Thrombocytopenia

Name

Location

Research Site Mesa, Arizona  
Research Site Anaheim, California  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Arlington Heights, Illinois  
Research Site Ames, Iowa  
Research Site Ashland, Kentucky  
Research Site Baton Rouge, Louisiana  
Research Site Baltimore, Maryland  
Research Site Battle Kreek, Michigan  
Research Site Billings, Montana  
Research Site Belleville, New Jersey  
Research Site Albany, New York  
Research Site Enid, Oklahoma  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas