BENITIONSClinical Trial Intelligence

A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.

Фаза 1/2 Идёт, набор закрыт NCT02734004

ЗаболеваниеOvarian, Breast, SCLC, Gastric Cancers
ФазаФаза 1/2
СпонсорAstraZeneca
СтатусИдёт, набор закрыт
Участники264 участн.
ВмешательствоOlaparib, MEDI4736, Bevacizumab
Дата начала17.03.2016
Дата завершения17.09.2021
Публикация результатов13.10.2023

Кратко

The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and bevacizumab (module 6). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.

Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12

RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019. · percentage of participants

Initial Stage: Small Cell Lung Cancer28.9 percentage of participants
Initial Stage: Breast Cancer80.0 percentage of participants
Initial Stage: Ovarian Cancer81.3 percentage of participants
Initial Stage: Gastric Cancer25.6 percentage of participants

Second Stage Cohort: Objective Response Rate (ORR)

RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021. · percentage of participants

Second Stage: Ovarian Cancer Expansion92.2 percentage of participants

Second Stage Cohorts: DCR at Week 24

RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021. · percentage of participants

Second Stage: Ovarian Cancer Triplet74.2 percentage of participants
Second Stage: Ovarian Cancer Doublet28.1 percentage of participants

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