Know Cancer

or
forgot password

A Randomized, Phase 2, Placebo-Controlled, Double-Blinded Study With and Without Enzastaurin in Combination With Paclitaxel and Carboplatin as First-Line Treatment, Followed by Maintenance Treatment in Advanced Ovarian Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Fallopian Tube Neoplasms, Peritoneal Neoplasm

Thank you

Trial Information

A Randomized, Phase 2, Placebo-Controlled, Double-Blinded Study With and Without Enzastaurin in Combination With Paclitaxel and Carboplatin as First-Line Treatment, Followed by Maintenance Treatment in Advanced Ovarian Cancer


Inclusion Criteria:



- Patients must have specific stages of disease, known as FIGO stages IIB, IIC, III or
IV

- Organ functions (blood, renal, liver, cardiac) must meet specific requirements.

- Patients, who could become pregnant, must take care not to become pregnant during the
study participation and for 6 months after study discontinuation

- Patients must give written consent for study participation.

Exclusion Criteria:

- Patients received any experimental drug within the last 30 days.

- Patients received any prior chemotherapy or other drug therapy for the current
disease.

- Patients receive any other treatment for the cancer during study participation.

- Patients are unable to discontinue concurrent administration of carbamazepine,
phenobarbital, or phenytoin.

- Patients are pregnant, breast feeding, or not using adequate contraceptive methods to
prevent pregnancy.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

baseline to progressive disease evaluated at 18 months

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

10708

NCT ID:

NCT00391118

Start Date:

November 2006

Completion Date:

July 2012

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasm
  • Neoplasms
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location