Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

This is a phase I/II open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK) and antitumor activity of MEDI4736 in combination with olaparib in patients with advanced solid tumors, selected based on a rationale for response to olaparib. Patients will be poly (adenosine diphosphate-ribose) polymerase (PARP)-inhibitor and immunotherapy (IMT)-naïve (defined as no prior exposure to PARP inhibitors or IMT, including, but not limited to, other anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], anti-programmed cell death 1 [PD-1], anti-programmed death-ligand 1 [PD-L1] monoclonal antibodies, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). The 4 initial stage cohorts (Modules 1 to 4) include patients with relapsed small cell lung cancer (SCLC), germline BRCA mutated (gBRCAm) metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer, gBRCAm platinum-sensitive relapsed ovarian cancer, and gastric cancer. The data cut-off occurred once all 4 Modules had reached last patient first visit (LPFV) + 2 years and all 4 cohorts had observed a median value for PFS. Second stage cohorts (Modules 5 to 7) include patients with relapsed gBRCAm platinum-sensitive relapsed ovarian cancer and non gBRCAm platinum-sensitive relapsed ovarian cancer. The final data cut-off will be once Modules 6 and 7 have observed a median value for overall survival. At this timepoint, the clinical study database will close to new data. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02734004
Study type Interventional
Source AstraZeneca
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date March 17, 2016
Completion date September 17, 2025

See also
  Status Clinical Trial Phase
Completed NCT05026593 - A Study of IBI110 in Combination With Sintilimab and Chemotherapy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer Phase 1
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Recruiting NCT05903092 - MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT00046787 - Efficacy and Safety Study of OSI-211 (Liposomal Lurtotecan) to Treat Recurrent Small Cell Lung Cancer Phase 2
Suspended NCT04826341 - A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors Phase 1/Phase 2
Recruiting NCT05655598 - TAS-116 Plus Palbociclib in Breast and Rb-null Cancer Phase 1
Withdrawn NCT04677361 - Feasibility Study on Expandion of MILs From NSCLC and SCLC Patients and Infusion With Pembrolizumab Early Phase 1
Terminated NCT00522639 - Predictive Value of FDG-PET-CT Scans for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation Phase 3
Completed NCT03428607 - Study of AZD6738 and Olaparib Combination Therapy in Relapsed Small Cell Lung Cancer Patients [SUKSES-N2] Phase 2
Recruiting NCT05546268 - Study of Oral MRT-2359 in Selected Cancer Patients Phase 1/Phase 2
Recruiting NCT06116019 - Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)
Not yet recruiting NCT03244904 - Next-generation Sequencing of Small Cell Lung Cancer to Identify Susceptibility Gene and to Assess Treatment N/A
Completed NCT01713296 - Pazopanib in Relapsed and Refractory Small Cell Lung Cancer Phase 2
Recruiting NCT04162041 - Topotecan Plus M6620 (VX-970) vs. Topotecan Alone in People With Relapsed Small-Cell Lung Cancer Phase 2
Recruiting NCT05130255 - GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 Phase 1
Recruiting NCT04686682 - A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors Phase 1/Phase 2
Recruiting NCT02611024 - Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors Phase 1/Phase 2
Recruiting NCT05879068 - A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC Phase 2
Recruiting NCT04684017 - Anlotinib Plus Etoposide and Carboplatin as First-line Treatment for Extensive-stage Small Cell Lung Cancer Phase 2
Completed NCT00346385 - BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors Phase 1