Phase 2
N=154
A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00642018 ↗Enrolled (actual)
154
Serious AEs
38.9%
Results posted
Apr 2019
Primary outcome: Primary: Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone — 9.00; 8.64 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- docetaxel (Drug); LY2181308 sodium (Drug); Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone |
9.00; 8.64 | — |
| PRIMARY Number of Participants With Adverse Events (Safety) |
11; 47; 50; 94 | — |
| SECONDARY Adverse Event Profile |
45; 91; 5; 27; 6; 22 | — |
| SECONDARY Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity) |
825; 799 | — |
| SECONDARY Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate) |
56.9; 56.1 | — |
| SECONDARY Estimate Overall Survival |
29.04; 27.04 | — |
| SECONDARY Estimate Duration of Overall Response |
10.81; 9.66 | — |
| SECONDARY Percentage of Participants With Complete Response or Partial Response (Overall Response Rate) |
21.6; 10.2 | — |
| SECONDARY Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses) |
-32.5; 233.3 | — |
| SECONDARY Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes) |
117; 115 | — |
| SECONDARY Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms) |
84; 80 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00642018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.