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A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Cancer, Castrate-Resistant Prostate Cancer, Mestastatic Prostate Cancer, Prostate Cancer

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Trial Information

A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer


Inclusion Criteria:



- Pathologically confirmed adenocarcinoma of the prostate

- Radiographic evidence of metastatic disease

- Progressive disease meeting at least one of the following criteria:

1. a sequence of at least 2 rising PSA values measured at a minimum of 1 week apart
with a 2 ng/mL minimum starting value, or

2. progression according to RECIST criteria for measurable lesions, or

3. appearance of 2 or more new lesions on bone scan.

- History of prior taxane-based chemotherapy for metastatic prostate cancer

- For patients without a history of surgical castration, continued GnRH analog
administration is required

- ECOG Performance status of 0 or 1

- Life expectancy ≥ 3 months

Exclusion Criteria:

- Treatment with external beam radiotherapy ≤ 14 days before enrollment or
radiopharmaceutical ≤8 weeks

- ≤ 4 weeks since receipt of most recent prior chemotherapy, non-GnRH analog hormonal
therapy (except for continuing corticosteroids) or other systemic therapy to treat
prostate cancer and <6 weeks since receipt of prior bevacizumab.

- Known CNS metastases (epidural disease is allowed if it has been treated and there is
no progression in the treated area).

- Significant cardiovascular disease

- LVEF < 50% by MUGA or ECHO

- Treatment of infection with systemic anti-infectives within 7 days before enrollment
(with the exception of uncomplicated urinary tract infection)

- Concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except
that use of low dose coumarin-type anticoagulants or heparins for prophylaxis against
central venous catheter thrombosis is allowed

- Major surgical procedure ≤30 days before enrollment or not yet recovered from prior
major surgery

- Presence of peripheral edema > Grade 2

- Known positive test for HIV, hepatitis C, chronic or active hepatitis B

- Serious or non-healing wound

- Unable to begin protocol specified treatment within 7 days after enrollment

- Other investigational procedures are excluded.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Phase 1b - Incidence of adverse events defined by dose-limiting toxicities

Outcome Time Frame:

21 days after the 6th subjects has recieved 1st cycle of AMG 102 in combination with MP

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Euorpean Union: Ethics Committee

Study ID:

20070611

NCT ID:

NCT00770848

Start Date:

November 2008

Completion Date:

April 2012

Related Keywords:

  • Cancer
  • Castrate-Resistant Prostate Cancer
  • Mestastatic Prostate Cancer
  • Prostate Cancer
  • CRPC
  • Prostatic Neoplasms

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