Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

NCT01419717 | Completed Phase 3 Results

• 1 other identifier: 20110113
• Study Type: interventional
• Target: 129
• Locations: 19 countries
• Sites: 64

Brief Summary

This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.

Conditions

Bone Metastases in Men With Hormone-Refractory Prostate Cancer; Bone Metastases in Subjects With Advanced Breast Cancer

Keywords

cancer; bone metastases; breast cancer; prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product.

  From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.

Secondary Outcomes (1)

• Number of Participants With Anti-denosumab Binding Antibodies

  Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months.

Study Arms (1)

Denosumab

EXPERIMENTAL

Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.

Drug: Denosumab

Interventions

Denosumab DRUG

Administered by subcutaneous injection every 4 weeks (Q4W)

Also known as: Xgeva

Denosumab

Eligibility Criteria

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

You may qualify if:

• Subject was previously enrolled in a denosumab phase 3 study and participated in the Open-label Extension portion of that study.
• Subject or subject's legally acceptable representative has provided informed consent.

You may not qualify if:

• Subject is of child bearing potential and planning to become pregnant within 7 months after the end of treatment.
• Subject is of child bearing potential and is not willing to use, in combination with her partner, two highly effective methods of contraception during treatment and for 7 months after the end of treatment.
• Subject has known sensitivity to any of the products to be administered during dosing.
• Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator's knowledge.
• Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.

Sponsors & Collaborators

• Amgen: lead

Study Sites (64)

Research Site

Capital Federal, Buenos Aires, C1426ANZ, Argentina

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Quilmes, Buenos Aires, B1878GEG, Argentina

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Córdoba, Córdoba Province, X5016KEH, Argentina

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Rosario, Santa Fe Province, S2000PBJ, Argentina

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Vienna, 1090, Austria

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Namur, 5000, Belgium

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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São Paulo, São Paulo, 01221-020, Brazil

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São Paulo, São Paulo, 01509-900, Brazil

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São Paulo, São Paulo, 04262-000, Brazil

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Sorocaba, São Paulo, 18030-200, Brazil

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Rio de Janeiro, 20551-030, Brazil

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Rio de Janeiro, 22640-000, Brazil

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São Paulo, 01209-000, Brazil

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Kroměříž, 767 55, Czechia

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Olomouc, 775 20, Czechia

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Prague, 110 00, Czechia

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Prague, 140 00, Czechia

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Prague, 140 44, Czechia

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Prague, 150 06, Czechia

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Saint-Cloud, 92210, France

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Debrecen, 4012, Hungary

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Dombóvár, 7200, Hungary

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Haifa, 31096, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 64239, Israel

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Ẕerifin, 70300, Israel

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Meldola (FC), 47014, Italy

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Sora, 03039, Italy

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Kure-shi, Hiroshima, 737-0023, Japan

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Kagoshima, Kagoshima-ken, 892-0833, Japan

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Isehara-shi, Kanagawa, 259-1193, Japan

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Osaka, Osaka, 540-0006, Japan

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Kitaadachi-gun, Saitama, 362-0806, Japan

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Chuo-ku, Tokyo, 104-0045, Japan

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Tokyo, 135-8550, Japan

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Daugavpils, 5417, Latvia

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Riga, 1079, Latvia

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Kaunas, 50009, Lithuania

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Vilnius, 08660, Lithuania

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Panama City, Panama

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Lima, Lima 18, Peru

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Lima, Lima 27, Peru

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Bialystok, 15-027, Poland

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Bydgoszcz, 85-171, Poland

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Gdansk, 80-952, Poland

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Lublin, 20-954, Poland

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Poznan, 61-866, Poland

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Warsaw, 00-631, Poland

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Arkhangelsk, 163045, Russia

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Chelyabinsk, 454087, Russia

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Krasnogorsky District, 143423, Russia

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Moscow, 115478, Russia

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Obninsk, 249036, Russia

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Omsk, 644013, Russia

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Saint Petersburg, 197089, Russia

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Pretoria, 0081, South Africa

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Seville, Andalusia, 41013, Spain

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Valencia, Valencia, 46009, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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Lviv, 79031, Ukraine

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Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Prostatic Neoplasms

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 18, 2011
• Study Start: November 22, 2011
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: September 24, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

PE (2); AR (4); CZ (6); IL (4); HU (2); JP (7); LA (2); ES (4); FR (1); PA (1); AU (1); IT (2); UA (1); BR (10); LI (2); RU (7); PL (6); ZA (1); BE (1)