Conditions

Prostate Cancer

Keywords

Hormone Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (2)

Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone
PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death, PFS was censored at their last contact. Participants were still followed for PFS after they stopped receiving study drug.
Baseline to measured progressive disease or death due to any cause up to 44.68 months
Number of Participants With Adverse Events (Safety)
Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months.
First treatment dose up to 19 months

Secondary Outcomes (9)

Adverse Event Profile
First treatment dose up to 19 months
Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity)
Predose up to 8 hours postdose in Cycle 1
Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate)
Baseline, 18 months
Estimate Overall Survival
First treatment to death due to any cause up to 45.54 months
Estimate Duration of Overall Response
Time of response to time of measured progressive disease up to 41.00 months
+4 more secondary outcomes

Other Outcomes (1)

Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment
Study treatment discontinuation up to 30 days post study treatment discontinuation

Study Arms (2)

A: Docetaxel

ACTIVE COMPARATOR

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

Drug: docetaxelDrug: Prednisone

B: LY2181308 + Docetaxel

EXPERIMENTAL

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

Drug: docetaxelDrug: LY2181308 sodiumDrug: Prednisone

Interventions

docetaxelDRUG

Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.

A: DocetaxelB: LY2181308 + Docetaxel

LY2181308 sodiumDRUG

LY2181308 sodium (referred to as LY2181308 throughout this record) administered weekly plus docetaxel 75 mg/m² intravenously administered every 21 days. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.

B: LY2181308 + Docetaxel

PrednisoneDRUG

Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy

A: DocetaxelB: LY2181308 + Docetaxel

Eligibility Criteria

Age18 Years - 75 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.