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AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer; Castrate-Resistant Prostate Cancer; Mestastatic Prostate Cancer; Prostate Cancer

Intervention: AMG 102 (Drug); AMG 102 (Drug); Mitoxantrone (Drug); Placebo (Drug); Prednisone (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

The primary objectives of this study are the following: Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC)

Clinical Details

Official title: 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

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

Primary outcome:

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

Phase 2 - Overall survival

Secondary outcome:

Phase 1b - Incidence of adverse events, abnormal laboratory values not defined as dose limiting toxicities

Phase 1b - Incidence of anti-AMG 102 antibody formation

Phase 1b - Cmax and Cmin of AMG 102 concentration

Phase 2 - Progression-free survival

Phase 2 - Maximum percentage reduction in PSA level

Phase 2 - PSA response rate (≥50% reduction in PSA values from baseline)

Phase 2 - Objective response rate (CR and PR per RECIST with modifications)

Phase 2 - Patient Report Outcome including pain-specific measures

Phase 2 - Incidence of adverse events and significant laboratory value changes from baseline

Phase 2 - Incidence of anti-AMG 102 antibody formation

Phase 2 - Cmax and Cmin of AMG 102; Cmax and AUC for Mitoxantrone

Phase 2 - Percentage change in PSA levels from baseline to 12 weeks (or earlier for those who discontinue therapy)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Related publications:

Oliner K.BM Ph2 CRPC.Journal-004521;

Ryan CJ, Rosenthal M, Ng S, Alumkal J, Picus J, Gravis G, Fizazi K, Forget F, Machiels JP, Srinivas S, Zhu M, Tang R, Oliner KS, Jiang Y, Loh E, Dubey S, Gerritsen WR. Targeted MET inhibition in castration-resistant prostate cancer: a randomized phase II study and biomarker analysis with rilotumumab plus mitoxantrone and prednisone. Clin Cancer Res. 2013 Jan 1;19(1):215-24. doi: 10.1158/1078-0432.CCR-12-2605. Epub 2012 Nov 7.

Starting date: November 2008
Last updated: February 6, 2014

Page last updated: August 23, 2015

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