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

Bone Metastases in Subjects With Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419717
• Other study ID #: 20110113
• Status: Completed
• Phase: Phase 3
• Start date: November 22, 2011
• Est. completion date: August 10, 2018

Study information

• Verified date: September 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases in Men With Hormone-Refractory Prostate Cancer
• Bone Metastases in Subjects With Advanced Breast Cancer
• Bone Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Prostatic Neoplasms

Intervention

Drug:
• Denosumab
Administered by subcutaneous injection every 4 weeks (Q4W)

Locations

Country	Name	City	State
Argentina	Research Site	Capital Federal	Buenos Aires
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Rosario	Santa Fe
Austria	Research Site	Wien
Belgium	Research Site	Namur
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Santo Andre	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	São Paulo
Brazil	Research Site	Sorocaba	São Paulo
Czechia	Research Site	Kromeriz
Czechia	Research Site	Olomouc
Czechia	Research Site	Praha 1
Czechia	Research Site	Praha 4
Czechia	Research Site	Praha 4
Czechia	Research Site	Praha 5
France	Research Site	Saint Cloud
Hungary	Research Site	Debrecen
Hungary	Research Site	Dombovar
Israel	Research Site	Haifa
Israel	Research Site	Rehovot
Israel	Research Site	Tel-Aviv
Israel	Research Site	Zerifin
Italy	Research Site	Meldola (FC)
Italy	Research Site	Sora
Japan	Research Site	Chuo-ku	Tokyo
Japan	Research Site	Isehara-shi	Kanagawa
Japan	Research Site	Kagoshima-shi	Kagoshima
Japan	Research Site	Kitaadachi-gun	Saitama
Japan	Research Site	Kure-shi	Hiroshima
Japan	Research Site	Osaka-shi	Osaka
Japan	Research Site	Tokyo
Latvia	Research Site	Daugavpils
Latvia	Research Site	Riga
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Vilnius
Panama	Research Site	Panama
Peru	Research Site	Lima
Peru	Research Site	Lima
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Warszawa
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Krasnogorsky District
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Obninsk
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	St Petersburg
South Africa	Research Site	Pretoria
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Sevilla	Andalucía
Spain	Research Site	Valencia	Comunidad Valenciana
Ukraine	Research Site	Lviv

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Brazil,  Czechia,  France,  Hungary,  Israel,  Italy,  Japan,  Latvia,  Lithuania,  Panama,  Peru,  Poland,  Russian Federation,  South Africa,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Anti-denosumab Binding Antibodies	A blood sample was collected at the end of study visit for the measurement of 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.

External Links

•   AmgenTrials clinical trials website