Phase 2
Completed N=154
A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
Source: ClinicalTrials.gov NCT00642018 ↗Enrolled (actual)
154
Serious AEs
38.9%
Results posted
Apr 2019
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.