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 - N/A

• Conditions: Patients with a histologic diagnosis of FIGO Stage IIB, IIC, III, or IV advanced invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma.; MedDRA version: 8.1Level: LLTClassification code 10033130Term: Ovarian cancer NOS

• Registration Number: EUCTR2006-002316-10-DE
• Lead Sponsor: Eli Lilly and Company limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-19
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 149

Inclusion Criteria

- present with a histologic diagnosis of FIGO Stage IIB, IIC, III, or IV advanced invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma.
- should be primarily optimal debulked (0 cm residual tumor) or sub-optimal debulked (>0 cm residual tumor) .
- must be enrolled within six weeks after laparotomy, but should not start treatment with chemotherapy or enzastaurin/placebo earlier than 3 weeks; and have recovered from surgery sufficiently to start study therapy.
- are women, who are at least 18 years of age.
- have an ECOG performance status of 0, 1, or 2.
- have adequate organ function including the following: Adequate bone marrow reserve and Hepatic and Renal functioning.
- signed informed consent from the patient for the study
- Reproductive potential of women must be surgically sterile, postmenopausal,
or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after the treatment period; women with reproductive potential must have a negative serum or urine pregnancy test within 3 days before study enrollment and must not be breast-feeding.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- receive concurrent administration of any other systemic anticancer therapy. Receive simultaneous administration of hormonal therapy during the study treatment period (hormone replacement therapy is allowed, as are steroid antiemetics).
- receive concurrent radiation therapy during the study treatment period.
- patients with a history of hypersensitivity reactions to products containing Cremophor EL (cyclosporine, castor oil, or vitamin K) and/or patients with known hypersensitivity to compounds chemically related to carboplatin, paclitaxel, or enzastaurin.
- are unable to discontinue concurrent administration of carbamazepine, phenobarbital, or phenytoin at least 14 days prior to study therapy.
- have an active infection, including active bacterial, fungal, or viral infection (at the discretion of the investigator), as well as other serious concomitant systemic disorders (for example, active infection including HIV, or cardiac disease) that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol.
- have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. Patients with a QTc prolongation >470 msec (females) and patients who have a congenital long-QT-syndrome in their own or family medical history should be excluded, at the investigator’s discretion. The investigator should consider the life-threatening nature of ovarian cancer and the overall potential risk and benefit to the patient.
- have a second primary malignancy (except adequately treated basal cell carcinoma of the skin) or a prior diagnosis of any malignancy less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
- have a history of central nervous system (CNS) disorder or metastases (unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study therapy). A screening computed tomography (CT) or magnetic resonance imaging (MRI) before enrollment in the absence of a clinical suspicion of brain metastases is not required.
- Are unable to swallow tablets.
- are pregnant, breast feeding, or not using adequate contraceptive methods to prevent pregnancy.
- are institutionalized on the basis of a court or administrative ruling (such as prisoners).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified