A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: docetaxel; Drug: LY2181308 sodium; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642018

10461

H8Z-MC-JACR (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to determine whether LY2181308 in combination with docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.

Enrollment: 154 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed adenocarcinoma of the prostate which is metastatic and/or unresectable
• Hormone refractory prostate cancer defined as progressive based by documented 2 increase Prostate specific antigen (PSA) values over a previous reference value.
• Eastern Cooperative Oncology Group (ECOG) status 0-2
• Adequate hematological functions, liver and renal functions

Exclusion criteria

• Known hypersensitivity to docetaxel or taxane therapy
• Documented central nervous system or leptomeningeal metastasis at time of study entry
• Had prior treatment with chemotherapy, bone-seeking radionuclides in past 6 weeks prior to enrollment, or radiotherapy involving more than 25% of marrow producing area.
• Evidence of painful and/or destructive bone metastases for which radiation therapy, bisphosphonates or bone-seeking radionuclides are necessary.
• Have received treatment in the last 30 day with a drug which has not received regulatory approval for any indication at the time of study entry.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

154 participants in 2 patient groups

A: Docetaxel

Active Comparator group

Description:

Standard of care (SOC) docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel therapy

Treatment:

Drug: Prednisone

Drug: docetaxel

B: LY2181308 + Docetaxel

Experimental group

Description:

LY2181308 administered with docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel

Treatment:

Drug: LY2181308 sodium

Drug: Prednisone

Drug: docetaxel