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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 SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteAmes, Iowa  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteBillings, Montana  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteEnid, Oklahoma  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas