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Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma

NCT ID: NCT02141347

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-22

Study Completion Date

2017-01-27

Brief Summary

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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

Detailed Description

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Primary objectives Part A: To investigate the safety and tolerability of tremelimumab when given to Japanese patients with advanced solid malignancies and define the dose(s) for further clinical evaluation.

Part B: To investigate the safety and tolerability of tremelimumab in combination with MEDI4736 when given to Japanese patients with advanced solid malignancies and to define the dose(s) for further clinical evaluation.

Part C: To investigate the safety and tolerability of tremelimumab when given to Japanese patients with unresectable pleural or peritoneal malignant mesothelioma.

Conditions

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Part A and B: Advanced Solid Malignancies Part C: Malignant Mesothelioma

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Part A

Dose escalation of tremelimumab mono therapy for advanced solid malignancies

Group Type OTHER

Tremelimumab

Intervention Type DRUG

Tremelimumab administered intravenously

Part B

Combination therapy of tremelimumab and MEDI4736 for advanced solid malignancies

Group Type OTHER

Tremelimumab

Intervention Type DRUG

Tremelimumab administered intravenously

MEDI4736

Intervention Type DRUG

MEDI4736 administered intravenously.

Part C

Fixed dose of tremelimumab for malignant mesothelioma

Group Type OTHER

Tremelimumab

Intervention Type DRUG

Tremelimumab administered intravenously

Interventions

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Tremelimumab

Tremelimumab administered intravenously

Intervention Type DRUG

MEDI4736

MEDI4736 administered intravenously.

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

Part C:
Minimum Eligible Age

20 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Bunkyō City, , Japan

Site Status

Research Site

Chūōku, , Japan

Site Status

Research Site

Hiroshima, , Japan

Site Status

Research Site

Nagoya, , Japan

Site Status

Research Site

Nishinomiya-shi, , Japan

Site Status

Research Site

Okayama, , Japan

Site Status

Research Site

Osaka, , Japan

Site Status

Research Site

Sapporo, , Japan

Site Status

Research Site

Sunto-gun, , Japan

Site Status

Research Site

Ube-shi, , Japan

Site Status

Research Site

Yokohama, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 35671201 (View on PubMed)

Other Identifiers

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D4880C00010

Identifier Type: -

Identifier Source: org_study_id