EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer

NCT01360840 | Completed Phase 2 Results DMC

• 1 other identifier: EMR 62242-006
• Study Type: interventional
• Target: 180
• Locations: 12 countries
• Sites: 71

Brief Summary

The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

Conditions

Prostate Cancer Metastatic

Keywords

Asymptomatic; mildly symptomatic; metastatic castrate-resistant prostate cancer; mCRPC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Time

  PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) modified as per Prostate Cancer Working Group 2 (PCWG-2); Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression/fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.

  Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years

Secondary Outcomes (14)

• Overall Survival

  Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years

• Time to Tumor Progression

  Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years

• Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions

  Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years

• Number of Subjects With New Bone Lesions Compared to Baseline

  Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years

• Number of Subjects With Presence of DC in Bone Lesions

  At Weeks 13, 19 and 25

Other Outcomes (1)

• To Explore the Relationship Between Number and/or Changes of Numbers of Biomarker and the Clinical Outcome

  From the date of randomization up to data cut-off date (30 April 2013), assessed up to 2 years

Study Arms (3)

Placebo + Standard of care (SoC)

PLACEBO COMPARATOR

Other: Placebo; Other: Standard of Care (SoC)

EMD 525797 750 mg + SoC

EXPERIMENTAL

Drug: EMD 525797; Other: Standard of Care (SoC)

EMD 525797 1500 mg + SoC

EXPERIMENTAL

Drug: EMD 525797; Other: Standard of Care (SoC)

Interventions

EMD 525797 DRUG

Subjects will be administered with EMD 525797 at a dose of 1500 milligram (mg) (diluted with 0.9 percent \[%\] sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.

EMD 525797 1500 mg + SoC

Placebo OTHER

Subjects will be administered with placebo (as 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.

Placebo + Standard of care (SoC)

Standard of Care (SoC) OTHER

All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists).

EMD 525797 1500 mg + SoC; EMD 525797 750 mg + SoC; Placebo + Standard of care (SoC)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate (Gleason score)
• Bisphosphonate treatment
• Stable, ongoing adequate testosterone suppression proven by hypogonadal levels of testosterone (less than or equal to) \<= 50 nanogram per deciliter \[ng/dL\]) for subjects without surgical castration (luteinizing hormone-releasing hormone antagonists and agonists)

You may not qualify if:

• Prior chemotherapy, biologic therapy (targeted therapy), or any experimental therapy for mCRPC
• Chronic and ongoing treatment with opioids
• Acute pathologic fracture, spinal cord compression, or hypercalcemia at Screening
• Visceral metastasis, brain metastasis
• Radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. Any kinds of major elective surgery within 30 days prior to trial treatment

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (71)

Research Site

Pleasant Hill, California, United States

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Chicago, Illinois, United States

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New Orleans, Louisiana, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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New Brunswick, New Jersey, United States

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Cleveland, Ohio, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Tyler, Texas, United States

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Roanoke, Virginia, United States

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Spokane, Washington, United States

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Bendigo, Australia

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Coffs Harbour, Australia

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Darlinghurst, Australia

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Frankston, Australia

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Gosford, Australia

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Kurralta Park, Australia

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Northmead, Australia

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Port Macquarie, Australia

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Randwick, Australia

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Turnhout, Australia

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ZNA Middelheim Oncologie

Antwerp, Belgium

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Brandord Urology Research

Brantford, Ontario, Canada

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Exdeo Clinical Research Inc.

Abbotsford, Canada

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Can-Med Clinical Research Inc.

Province of British Columbia, Canada

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Sunnybrook Health Sciences Centre

Toronto, Canada

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Victoria, Canada

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Windsor, Canada

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Angers, France

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Center Alexis Vaurrin

Bourgogne, France

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Caen, France

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Hôpitaux Civils de Colmar-CH Louis Pasteur

Colmar, France

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Paris, France

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Reims, France

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Institute Gustave Roussy

Villejuif, France

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Aachen, Germany

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Universitätsmedizin Charité, Campus Benjamin Franklin, Urologische Klinik and Poliklinik

Berlin, Germany

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Darmstadt, Germany

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Universitätsklinikum Carl Gustav Carus an der Techischen Universität Dresden, Klinik und Poliklinik für Urologie

Dresden, Germany

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Esslingen am Neckar, Germany

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Freiburg im Breisgau, Germany

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Hanover, Germany

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Nürtingen, Germany

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Studienpraxis Urologie

Reutlingen, Germany

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Universitätsklinikum Tübinger, Klinik und Poliklinik für Urologie

Tübingen, Germany

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Blaricum, Netherlands

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Groningen, Netherlands

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Haarlem, Netherlands

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Gdansk, Poland

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Lodz, Poland

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Lublin, Poland

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Altay Regional Oncology Dispensary

Barnaul, Russia

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Barnaul, Russia

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State Institution of Healthcare Ivanovo Regional Oncology Dispensary

Ivanovo, Russia

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Budzhet Clinical Oncology Center

Izhevsk, Russia

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Kazan', Russia

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Krasnoyarsk State Medical University Oncology and Radiotherapy Territorial Dispensary

Krasnoyarsk, Russia

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Omsk, Russia

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City Hospital # 2

Saint Petersburg, Russia

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Stavropol, Russia

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Yekaterinburg, Russia

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Prešov, Slovakia

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Gauteng, South Africa

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Kwa-Zulu Natal, South Africa

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Pretoria Gauteng, South Africa

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Western Cape, South Africa

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Barcelona, Spain

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Madrid, Spain

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Pamplona, Spain

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Sabadell, Barcelone, Spain

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MeSH Terms

Interventions

Abituzumab; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: May 26, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2014
• Last Updated: December 14, 2015
• Results First Posted: December 14, 2015

Record last verified: 2015-11

Locations

NL (3); PL (3); ZA (4); SL (1); FR (7); US (12); AU (10); DE (10); RU (10); CA (6); BE (1); ES (4)