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A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Hormone Refractory Prostate Cancer


Phase 2
18 Years
75 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Hormone Refractory Prostate Cancer


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 PSA values over a previous reference value.

- 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 radionucleides 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,
biophosphonates or boneseeking radionucleides 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the progression-free survival (PFS)in patients with HRPC administered LY2181308 sodium plus docetaxel compared to docetaxel alone

Outcome Time Frame:

26 months

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

10461

NCT ID:

NCT00642018

Start Date:

March 2008

Completion Date:

April 2012

Related Keywords:

  • Prostate Cancer
  • Hormone Refractory Prostate Cancer
  • Prostatic Neoplasms

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Memphis, Tennessee  38138