A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours
NCT ID: NCT01938612
Last Updated: 2021-03-12
Study Results
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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COMPLETED
PHASE1
269 participants
INTERVENTIONAL
2013-09-12
2020-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MEDI4736 Q2W
Evaluate MEDI4736 given every 2 weeks
MEDI4736
MEDI4736 will be administered by IV infusion every 14, 21 or 28 days.
MEDI4736 Q3W
Evaluate MEDI4736 given every 3 weeks
MEDI4736
MEDI4736 will be administered by IV infusion every 14, 21 or 28 days.
MEDI4736 Dose Expansion
evaluate MEDI4736 given every 2 weeks
MEDI4736
MEDI4736 will be administered by IV infusion every 14, 21 or 28 days.
MEDI4736 Q4W
Evaluate MEDI4736 given every 4 weeks
MEDI4736
MEDI4736 will be administered by IV infusion every 14, 21 or 28 days.
MEDI4736 combined with another drug
evaluate MEDI4736 in combination with another drug given every 4 weeks
tremelimumab
tremelimumab is administered by IV infusion every 4 weeks
Interventions
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MEDI4736
MEDI4736 will be administered by IV infusion every 14, 21 or 28 days.
tremelimumab
tremelimumab is administered by IV infusion every 4 weeks
Eligibility Criteria
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Inclusion Criteria
In the dose-expansion phase: histologically- or cytologically-confirmed advanced or metastatic biliary tract cancer (BTC), esophagus cancer(EC) (squamous cell carcinoma) or squamous cell carcinoma of the head and neck (SCCHN). - men or women. - Eastern Cooperative Oncology Group (ECOG) status of 0 or 1. - Adequate organ and marrow function. - Subjects must have at least 1 measurable lesion. - Available archived tumor tissue sample. - Willingness to provide consent for biopsy samples.
Exclusion Criteria
20 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Iannone, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Beppu-shi, , Japan
Research Site
Chūōku, , Japan
Research Site
Kashiwa, , Japan
Research Site
Kitaadachi-gun, , Japan
Research Site
Kōtoku, , Japan
Research Site
Kure-shi, , Japan
Research Site
Matsuyama, , Japan
Research Site
Nagoya, , Japan
Research Site
Osaka, , Japan
Research Site
Sapporo, , Japan
Research Site
Sapporo, , Japan
Research Site
Sayama, , Japan
Research Site
Suita-shi, , Japan
Research Site
Sunto-gun, , Japan
Research Site
Takatsuki-shi, , Japan
Research Site
Yokohama, , Japan
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Countries
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References
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Doki Y, Ueno M, Hsu CH, Oh DY, Park K, Yamamoto N, Ioka T, Hara H, Hayama M, Nii M, Komuro K, Sugimoto M, Tahara M. Tolerability and efficacy of durvalumab, either as monotherapy or in combination with tremelimumab, in patients from Asia with advanced biliary tract, esophageal, or head-and-neck cancer. Cancer Med. 2022 Jul;11(13):2550-2560. doi: 10.1002/cam4.4593. Epub 2022 May 24.
Other Identifiers
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D4190C00002
Identifier Type: -
Identifier Source: org_study_id
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