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

NCT ID: NCT00770848

Last Updated: 2014-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2012-04-30

Brief 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)

Conditions

Cancer; Castrate-Resistant Prostate Cancer; Mestastatic Prostate Cancer; Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Phase 1b - AMG 102

Phase 1b is an open-label study with AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed, will be administered by IV Q3W in combination with MP.

Group Type: OTHER

AMG 102

Intervention Type: DRUG

Investigational product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment, will be administered by IV Q3W.

Mitoxantrone

Intervention Type: DRUG

Administered Q3W for a maximum of 12 cyles

Prednisone

Intervention Type: DRUG

5 mg orally BID

Phase 2 Arm A - AMG 102 + MP

AMG 102 safe dose level in phase 1b in combination with MP, will be administered by IV Q3W.

Group Type: EXPERIMENTAL

AMG 102

Intervention Type: DRUG

Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.

Mitoxantrone

Intervention Type: DRUG

Administered Q3W for a maximum of 12 cyles

Prednisone

Intervention Type: DRUG

5 mg orally BID

Phase 2 Arm C- PLACEBO

Placebo in combination with MP, will be administered by IV Q3W.

Group Type: PLACEBO_COMPARATOR

Mitoxantrone

Intervention Type: DRUG

Administered Q3W for a maximum of 12 cyles

Placebo

Intervention Type: DRUG

Placebo

Prednisone

Intervention Type: DRUG

5 mg orally BID

Phase 2 Arm B - AMG 102 + MP

Safe dose level in phase 1b of AMG 102 + MP will be administered by Q3W

Group Type: EXPERIMENTAL

AMG 102

Intervention Type: DRUG

Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.

Mitoxantrone

Intervention Type: DRUG

Administered Q3W for a maximum of 12 cyles

Prednisone

Intervention Type: DRUG

5 mg orally BID

Interventions

AMG 102

Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.

Intervention Type: DRUG

AMG 102

Investigational product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment, will be administered by IV Q3W.

Intervention Type: DRUG

Mitoxantrone

Administered Q3W for a maximum of 12 cyles

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Prednisone

5 mg orally BID

Intervention Type: DRUG

Other Intervention Names

Rilotumumab; Rilotumumab

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Oliner K.BM Ph2 CRPC.Journal-004521;

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 23136195 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20070611

Identifier Type: -

Identifier Source: org_study_id