Know Cancer

or
forgot password

A Phase 3 Study of Safety and Efficacy of Karenitecin Versus Topotecan Administered for 5 Consecutive Days Every 3 Weeks in Patients With Advanced Epithelial Ovarian Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

Thank you

Trial Information

A Phase 3 Study of Safety and Efficacy of Karenitecin Versus Topotecan Administered for 5 Consecutive Days Every 3 Weeks in Patients With Advanced Epithelial Ovarian Cancer


Inclusion Criteria:



- Age ≥ 18 years

- Confirmed diagnosis of stage III or IV epithelial ovarian cancer

- Have cancer that is resistant to platinum/taxane-based chemotherapy regimens

- Have measurable, progressive disease

- Have an ECOG PS ≤ 2

Exclusion Criteria:

- Have uncontrolled high blood pressure, uncontrolled diabetes mellitus, or other
serious underlying medical condition not compatible with study entry.

- Have a life expectancy < 3 months

- Received prior treatment with a camptothecin (topotecan, CPT-11, or investigational
camptothecins).

- Received prior treatment with any platinum agent other than cisplatin or carboplatin.

- Received prior radiation therapy to greater than one-third of the hematopoietic sites
(one-third of the pelvis and axial skeleton combined).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

baseline to measured progressive disease

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

KTN32313R

NCT ID:

NCT00477282

Start Date:

August 2007

Completion Date:

November 2014

Related Keywords:

  • Ovarian Cancer
  • Ovarian
  • Cancer
  • Advanced Ovarian Cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location