Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma
A Ph1 Open-Label Multicentre Study to Assess Safety, Tolerability, PK and Anti-tumor Activity of Tremelimumab /Tremelimumab With MEDI4736 in Japanese With Advanced Solid Malignancies or Tremelimumab in Japanese With Malignant Mesothelioma
1 other identifier
interventional
65
1 country
11
Brief Summary
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2014
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2014
CompletedFirst Posted
Study publicly available on registry
May 19, 2014
CompletedStudy Start
First participant enrolled
May 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2017
CompletedDecember 12, 2018
December 1, 2018
2.7 years
May 14, 2014
December 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse event
To investigate the safety and tolerability of tremelimumab and/ or MEDI4736 when given to Japanese patients
From time of informed consent to 90 days after the last dose
Study Arms (3)
Part A
OTHERDose escalation of tremelimumab mono therapy for advanced solid malignancies
Part B
OTHERCombination therapy of tremelimumab and MEDI4736 for advanced solid malignancies
Part C
OTHERFixed dose of tremelimumab for malignant mesothelioma
Interventions
Eligibility Criteria
You may not qualify if:
- Part C:
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (11)
Research Site
Bunkyō City, 113-8431, Japan
Research Site
Chūōku, 104-0045, Japan
Research Site
Hiroshima, 734-8551, Japan
Research Site
Nagoya, 464-8681, Japan
Research Site
Nishinomiya-shi, 663-8501, Japan
Research Site
Okayama, 702-8055, Japan
Research Site
Osaka, 541-8567, Japan
Research Site
Sapporo, 003-0804, Japan
Research Site
Sunto-gun, 411-8777, Japan
Research Site
Ube-shi, 755-0241, Japan
Research Site
Yokohama, 236-0051, Japan
Related Publications (1)
Fujiwara Y, Takahashi Y, Okada M, Kishimoto T, Kondo S, Fujikawa K, Hayama M, Sugeno M, Ueda S, Komuro K, Lanasa M, Nakano T. Phase I Study of Tremelimumab Monotherapy or in Combination With Durvalumab in Japanese Patients With Advanced Solid Tumors or Malignant Mesothelioma. Oncologist. 2022 Sep 2;27(9):e703-e722. doi: 10.1093/oncolo/oyac099.
PMID: 35671201DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2014
First Posted
May 19, 2014
Study Start
May 22, 2014
Primary Completion
January 27, 2017
Study Completion
January 27, 2017
Last Updated
December 12, 2018
Record last verified: 2018-12