A Study LY2228820 for Recurrent Ovarian Cancer

Lilly

Status and phase: Completed; Phase 2; Phase 1

Conditions: Primary Peritoneal Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer

Treatments: Drug: Carboplatin; Drug: Placebo; Drug: LY2228820; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01663857

12517

I1D-MC-JIAE (Other Identifier)

Details and patient eligibility

About

A study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy.

Full description

Phase 1b is unblinded and will have a small number of participants that will take LY2228820 plus gemcitabine and carboplatin to test the safety of the combination and determine a recommended dose for the Phase 2 portion.

Phase 2 will be blinded and all study participants will receive carboplatin and gemcitabine. Participants of one group will receive LY2228820, and the other group will receive placebo.

If the participant achieves at least stable disease, there is a maintenance phase following the first 6 cycles. The participant will take either LY2228820 or placebo. The participant will continue therapy until disease progression or other discontinuation criteria are fulfilled.

Enrollment: 118 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer
• Have been treated one time with a platinum-based chemotherapy and your disease has come back at least six months after you completed treatment
• Are able to swallow tablets
• Have given written informed consent prior to any study procedures
• Have adequate blood counts, hepatic and renal function
• Have performance status equal to or less than 2 on Eastern Cooperative Oncology Group (ECOG) scale
• Have negative pregnancy test, and if participant is of child bearing potential must use birth control while on study and for three months after stopping study drug

Exclusion criteria

• Have been previously treated with Gemcitabine for ovarian, fallopian tube or primary peritoneal cancer
• Are currently enrolled or discontinued less than 14 days from another clinical trial
• Have a history of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• Have taken certain medications or had grapefruit juice within 7 days of initial dose of study drug, as levels of the study drug may be affected.
• Must not be pregnant or breastfeeding.
• Have malignancy or metastasis of the central nervous system
• Have borderline malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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118 participants in 4 patient groups, including a placebo group

Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)

Experimental group

Description:

Cohort 1: Cycles 1-6 (21 day cycles)- LY2228820 200 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 milligrams per square meter (mg/m\^2) administered intravenously (IV) over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3.. Cohort 1: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.

Treatment:

Drug: LY2228820

Drug: Gemcitabine

Drug: Carboplatin

Phase 1b (Cohort 2) LY2228820 300 mg

Experimental group

Description:

Cohort 2: Cycles 1-6 (21 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m\^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3. Cohort 2: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.

Treatment:

Drug: LY2228820

Drug: Gemcitabine

Drug: Carboplatin

Phase 2 (Arm A) LY2228820 200 mg

Experimental group

Description:

Arm A: Cycles 1-6 (21 day cycles)- LY2228820 200 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m\^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3. Arm A: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.

Treatment:

Drug: LY2228820

Drug: Gemcitabine

Drug: Carboplatin

Phase 2 (Arm B) Placebo

Placebo Comparator group

Description:

Arm B: Cycles 1-6 (21 day cycles)- Placebo administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m\^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3. Arm B: Cycle 7+ (28 day cycles)- Placebo administered orally on days 1-14 to maintain blind.

Treatment:

Drug: Placebo

Drug: Gemcitabine

Drug: Carboplatin