AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00770848

Purpose

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)

Condition	Intervention	Phase
Cancer Castrate-Resistant Prostate Cancer Mestastatic Prostate Cancer Prostate Cancer	Drug: AMG 102	Phase I Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Mitoxantrone Mitoxantrone hydrochloride

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Phase 1b - Incidence of adverse events defined by dose-limiting toxicities [ Time Frame: 21 days after the 6th subjects has recieved 1st cycle of AMG 102 in combination with MP ] [ Designated as safety issue: Yes ]
Phase 2 - Overall survival [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Phase 1b - Incidence of adverse events, abnormal laboratory values not defined as dose limiting toxicities [ Time Frame: Treatment Period ] [ Designated as safety issue: Yes ]
Phase 1b - Incidence of anti-AMG 102 antibody formation [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
Phase 1b - Cmax and Cmin of AMG 102 concentration [ Time Frame: Treatment Period ] [ Designated as safety issue: Yes ]
Phase 2 - Progression-free survival [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
Phase 2 - Maximum percentage reduction in PSA level [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
Phase 2 - PSA response rate (≥50% reduction in PSA values from baseline) [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
Phase 2 - Objective response rate (CR and PR per RECIST with modifications) [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
Phase 2 - Patient Report Outcome including pain-specific measures [ Time Frame: Treatment Period ] [ Designated as safety issue: No ]
Phase 2 - Incidence of adverse events and significant laboratory value changes from baseline [ Time Frame: Treatment Period ] [ Designated as safety issue: Yes ]
Phase 2 - Incidence of anti-AMG 102 antibody formation [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
Phase 2 - Cmax and Cmin of AMG 102; Cmax and AUC for Mitoxantrone [ Time Frame: Treatment Period ] [ Designated as safety issue: Yes ]
Phase 2 - Percentage change in PSA levels from baseline to 12 weeks (or earlier for those who discontinue therapy) [ Time Frame: Treatment Period ] [ Designated as safety issue: No ]

Enrollment:	162
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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. Other Names: Mitroxantrone - 12mg/m2 by IV Q3W Prednisone - 5mg BID orally
Experimental: Phase 2 - AMG 102 AMG 102 safe dose level in phase 1b in combination with MP, will be administered by IV Q3W.	Drug: AMG 102 Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W. Other Names: Prednisone - 5mg BID orally Mitoxantrone - 12mg/m2 by IV Q3W
Placebo Comparator: Phase 2 - PLACEBO Placebo in combination with MP, will be administered by IV Q3W.	Drug: AMG 102 Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W. Other Names: Prednisone - 5mg BID orally Mitoxantrone - 12mg/m2 by IV Q3W

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770848

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00770848 History of Changes
Other Study ID Numbers:	20070611
Study First Received:	October 9, 2008
Last Updated:	September 8, 2011
Health Authority:	Euorpean Union: Ethics Committee; United States: Food and Drug Administration; United States: Institutional Review Board; United States: Western Institutional Review Board

Keywords provided by Amgen:

CRPC

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Mitoxantrone
Prednisone
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012