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

  • STATUS
    Not Recruiting
  • End date
    Aug 5, 2022
  • participants needed
    427
  • sponsor
    AstraZeneca
Updated on 5 May 2021
measurable disease
bevacizumab
medi4736
human epidermal growth factor
adenocarcinoma
solid tumour
solid tumor
olaparib
ovarian cancer
erbb2
recurrent small cell lung cancer

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, 8 and 9) and MEDI4736 in combination with olaparib and bevacizumab (module 6 and 10). 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

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)-nave (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. Enrollment for these cohorts has been completed.

Second stage cohorts (Modules 5 to 7) will include patients with relapsed BRCAm platinum-sensitive relapsed ovarian cancer and non BRCAm platinum-sensitive relapsed ovarian cancer.

Third stage cohorts (Modules 8 to 10) will include patients with HER2-negative, BRCAm breast cancer (Module 8), HER2 negative, non BRCAm, Homologous Recombination Repair gene mutated (HRRm) breast cancer (Module 9) and non BRCAm, non HRRm triple negative breast cancer (TNBC) breast cancer (Module 10).

Details
Condition Oat cell carcinoma, Breast, Small Cell Lung Cancer, Gastropathy, Gastric Cancer, Stomach Discomfort, Ovarian, Stomach Cancer
Treatment bevacizumab, MEDI4736, olaparib
Clinical Study IdentifierNCT02734004
SponsorAstraZeneca
Last Modified on5 May 2021

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note