Know Cancer

or
forgot password

Randomized, Double-Blind, Placebo Controlled, Phase 2 Study of Pemetrexed and Cisplatin Plus Enzastaurin Versus Pemetrexed and Cisplatin Plus Placebo in Chemonaive Patients With Advanced, Unresectable, or Metastatic (Stage IIIB or IV) Nonsquamous Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Randomized, Double-Blind, Placebo Controlled, Phase 2 Study of Pemetrexed and Cisplatin Plus Enzastaurin Versus Pemetrexed and Cisplatin Plus Placebo in Chemonaive Patients With Advanced, Unresectable, or Metastatic (Stage IIIB or IV) Nonsquamous Non-Small Cell Lung Cancer


Inclusion Criteria:



- diagnosis of advanced non-small cell lung cancer (NSCLC) not amenable to curative
treatment. Patients enrolling in Part 2 of the study must have the above stated
diagnosis of NSCLC that is also of nonsquamous histology.

- no prior systemic therapies (chemotherapy, etc.)or pleurodesis with chemotherapy for
this disease

- prior radiotherapy is allowed but must be completed at least 2 weeks before study
enrollment and patient must be recovered from the acute toxic effects

- have a good performance status

- patient must sign an informed consent document

Exclusion Criteria:

- patient had myocardial infarction occurring less than 6 months before inclusion,
uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac failure not
controlled by medications

- patient is unable to swallow tablets

- patient is taking a certain medicine to control seizure activity, called "enzyme
inducing antiepileptic drugs" and is not able to stop taking the medicine prior to
enrolling in the study

- patient is unable to interrupt aspirin and/or other anti-inflammatory agents

- patient is unwilling or unable to take vitamin supplementation (folic acid and
vitamin B12) or medications to prevent side effects

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Part 1: evaluate safety (toxicity, serious adverse events and reasons for patient discontinuation)

Outcome Time Frame:

each cycle

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UCT/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

10722

NCT ID:

NCT00538681

Start Date:

September 2007

Completion Date:

November 2008

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms

Name

Location