Prostate Cancer
Conditions
Brief summary
This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).
Interventions
DRUGTAK-700
TAK-700 will be administered orally (PO) twice daily (BID) on a continuous schedule
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each patient must meet all of the following inclusion criteria: * Male patients 18 years or older * Eastern Cooperative Oncology Group performance status 0-2 * Male patients who Practice effective barrier contraception during study and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse. * Voluntary written consent * Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma without radiographic evidence of metastasis but with a rising PSA during or following the patient's most recent antineoplastic therapy despite castrate concentrations of testosterone * Baseline PSA must be greater than or equal to 2 ng/mL and PSA doubling time must be less than or equal to 8 months OR baseline PSA must be greater than or equal to 8 ng/mL if PSA doubling time is greater than 8 months * Has undergone orchiectomy or will continue receiving GnRH analogue therapy * Meet screening laboratory values as specified in protocol
Exclusion criteria
Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 3 months of TAK-700 treatment | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| To determine PSA response rate (PSA decline of at least 90%, 50% and 30% from baseline)at 3 and 6 months | 3 and 6 months |
| To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 6 months of TAK-700 treatment | 6 months |
| To determine time to PSA progression, time to metastases, and duration of progression-free survival | Evidence of PSA or disease progression |
| To monitor changes in endocrine markers | Evidence of PSA or disease progression |
| To evaluate the safety of TAK-700 | Evidence of PSA or disease progression |
Countries
United States
Outcome results
None listed