Spots Global Cancer Trial Database for Phase Ib Study AZD1775 in Combination With Carboplatin and Paclitaxel in Adult Asian Patients With Solid Tumours
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Trial Identification
Brief Title: Phase Ib Study AZD1775 in Combination With Carboplatin and Paclitaxel in Adult Asian Patients With Solid Tumours
Official Title: A Phase Ib, Dose Finding Study Evaluating AZD1775 in Monotherapy, in Combination With Carboplatin and Paclitaxel, and in Combination With Only Carboplatin in Adult Asian Patients With Advanced Solid Tumours
Study ID: NCT02341456
Conditions
Study Description
Brief Summary: This is a phase Ib, open-label, multicentre study of AZD1775 administered orally in monotherapy and in combination with carboplatin and paclitaxel to Asian patients with advanced solid tumours.
Detailed Description: This is a phase Ib, open label, multicentre study of AZD1775 administered orally in monotherapy and in combination with carboplatin and paclitaxel in Asian patients with advanced solid tumours. The study design allows escalation or de-escalation of AZD1775 in combination with carboplatin and paclitaxel with intensive safety monitoring to ensure the safety of the patients. Approximately 12 evaluable patients will be enrolled in the dose-finding portion of this study. The total number of patients will depend upon the number of combination dose level evaluations necessary to define the recommended dose for further clinical evaluation. The proposed combination doses are : Dose level-1; Dose level 1; Dose level 2 (if Dose Level 1 tolerated). All combination doses other than Combination Dose level 1 may be subject to change by the SRC in light of emerging data. At least 3 and up to 6 evaluable patients will be required for each dose finding cohort. Once the recommended dose for further clinical evaluation is established, additional 3 to 6 patients may be enrolled to the cohort where the recommended dose has been defined to further characterise the safety, tolerability, pharmacokinetics, and efficacy profiles of AZD1775 in combination with paclitaxel and carboplatin. If this dose is subsequently found to be non-tolerated, alternative doses and/or schedules may be explored. This will be determined by the SRC.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Liverpool, , Australia
Research Site, Melbourne, , Australia
Research Site, Kashiwa, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Contact Details
Name: Dr. Paul De Souza, MD
Affiliation: Liverpool Hospital, New South Wales
Role: PRINCIPAL_INVESTIGATOR
Name: Dr. Jason Lickliter, MD
Affiliation: Nucleus Network Limited, Victoria
Role: PRINCIPAL_INVESTIGATOR
Name: Dr. Noboru Yamamoto, MD
Affiliation: NCC Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Dr Toshihiko Doi, MD
Affiliation: NCC Hospital (East)
Role: PRINCIPAL_INVESTIGATOR
Name: Prof Yung Ju Bang
Affiliation: Seoul National University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Prof Sang Prof Sang
Affiliation: Asan Medical Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Prof Keunchil Park
Affiliation: Samsung Medical Centre
Role: PRINCIPAL_INVESTIGATOR
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