Trial Information

Summary: National Phase 1 / 2 Ovarian Cancer study investigating the effectiveness and safety of ZK-Epo in combination with Carboplatin in women with platinum-sensitive, recurrent ovarian cancer

ZK-Epo is an Epothilone, a new class of chemotherapy, that has demonstrated activity against ovarian cancer and other tumor types in pre-clinical studies.

To date, ZK-Epo has been given to more than 200 cancer patients. These patients have been enrolled in studies of solid tumor cancers such as breast cancer, ovarian cancer, prostate cancer, non small cell and small cell lung cancer, and head and neck cancers.

Participants in this study must have recurrence of their ovarian cancer after a progression-free and platinum free interval of 6 to 24 months following completion of a first line platinum based chemotherapy. Patients should have a measurable tumor or an elevated CA 125 blood level.

During Part 1 of the study, the optimal dose of ZK-Epo to be used in combination with Carboplatin during Part 2 of the study will be determined. Part 1 of the trial will involve 18 patients at approximately 30 participating sites across the US and Canada. Part 2 of the trial will determine the initial safety and efficacy of ZK-Epo when given in combination with Carboplatin in patients with stage 4 ovarian cancer. All eligible patients will receive active study drug. The study drug will be given every 3 weeks for up to 18 weeks. All patients will be asked to return to the clinic every week while they are receiving study drug and then monthly for 3 months after their last dose of study drug.

Patients entered in the clinical trial will receive trial-related medical care and study drug at no charge.

Patients must meet the following criteria to enroll in this study:

• Women, 18 years of age or older
• Have stage 4 ovarian cancer, fallopian tube cancer, or peritoneal cavity cancer
• Have progressive disease following previous chemotherapy
• No more than one previous course of platinum based chemotherapy (like Cisplatin, Carboplatin)
• Have at least one measurable tumor or an elevated CA125 blood level
• Able to carry out normal daily activities
• Not currently pregnant or breastfeeding

Call Center : 1-877-919-5376, or log on to www.ovarian.zkepo.com

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.