Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma
- Sponsor
- AstraZeneca
- Study ID
- NCT02141347
- Phase
- PHASE1
- Status
- Completed
Conditions
- Part A and B: Advanced Solid Malignancies
- Part C: Malignant Mesothelioma
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 130 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tremelimumab — DRUGTremelimumab administered intravenously
- MEDI4736 — DRUGMEDI4736 administered intravenously.
Study Details
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
Key Dates
- Start date
- May 22, 2014
- Status verified
- Dec 2018
- Primary completion
- Jan 27, 2017
- Completion
- Jan 27, 2017
Study Design
- Enrollment
- 65 participants (actual)
- Allocation
- NON_RANDOMIZED
- Primary purpose
- OTHER
Arms
- Other: Part ADose escalation of tremelimumab mono therapy for advanced solid malignancies
- Other: Part BCombination therapy of tremelimumab and MEDI4736 for advanced solid malignancies
- Other: Part CFixed dose of tremelimumab for malignant mesothelioma
Primary Outcome Measure
Adverse event [ Time Frame: From time of informed consent to 90 days after the last dose ]