Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors

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Brief Title

Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors

Official Title

A Phase II Study of Olaparib and Durvalumab (MEDI 4736) in Patients With IDH-Mutated Solid Tumors

Brief Summary

      This is a phase 2 study of the combination of drugs olaparib and durvalumab for the treatment
      of isocitrate dehydrogenase or (IDH) mutated solid tumors. The purpose of this study is to
      assess the efficacy of the drug combination via overall response rate and overall disease
      control rate.

      It is believed that giving olaparib and durvalumab together would be more useful when given
      to patients with IDH-mutated solid tumors than giving each drug alone.
    

Detailed Description

      Patients with documented IDH mutations will be screened for eligibility within 4 weeks of the
      start of study treatment including medical history, physical exam, height, weight, vital
      signs, performance status, routine blood lab tests, pregnancy test, ECG, and tumor
      measurements for safety, and research blood and archival tumor tissue collection for
      biomarker research. In the event participants require surgery or biopsy during their
      participation in the study, samples of the tumor tissue removed will be collected for
      biomarker research.

      Eligible participants will be assigned to a cohort depending on their type of cancer:

        -  Cohort A: IDH-mutated glioma (a type of brain/spinal cord cancer)

        -  Cohort B: IDH-mutated cholangiocarcinoma (a type of bile duct cancer)

        -  Cohort C: All other IDH-mutated solid tumors

      While on the study drugs, participants will have many of the screening tests and procedures
      repeated for safety and for biomarker research.

      If participants are permanently taken of the study drugs for any reason, they will be asked
      to return to the clinic about 4 weeks after the last dose of study drugs to have tests and
      procedures done during the study repeated for safety and research purposes.

      After the End of Study Drug visit, participants will continue to be followed-up by telephone
      or by clinic visit every 8-12 weeks until they no longer wish to be followed or they start a
      new anti-cancer treatment, or until 1 year after your last dose of study drugs.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall response rate

Secondary Outcome

 Progression-free survival

Condition

Glioma

Intervention

Olaparib

Study Arms / Comparison Groups

 Cohort A: IDH mutated glioma
Description:  Olaparib, by mouth (orally), twice a day, every day. Durvalumab, by vein (intravenously), on Day 1 of every 28 day cycle.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

78

Start Date

December 31, 2019

Completion Date

September 2, 2023

Primary Completion Date

September 2, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures.

          -  Must be ≥ 18 years.

          -  Body weight > 30 kg.

          -  For Cohort A: Patients must have histologically or cytologically confirmed diffuse
             astrocytic and oligodendroglial tumors by World Health Organization 2016
             classification which are IDH mutant. They must have not received more than 2 regimens
             of systemic therapy after initial relapse.

          -  For Cohort B: Patients must have histologically or cytologically confirmed
             adenocarcinoma of the biliary tract which are IDH mutant. They must have not received
             more than 2 regimens of systemic therapy for advanced disease.

          -  For Cohort C: Patients must have histologically or cytologically confirmed cancers
             arising from a solid organ which are IDH mutant. They must have not received more than
             2 regimens of systemic therapy for advanced disease.

          -  Patients must have normal organ and bone marrow function measured within 28 days prior
             to administration of study treatment

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

          -  Patients must have a life expectancy ≥ 16 weeks.

          -  All participants must agree to use methods to prevent pregnancy as agreed upon between
             the participant and the study doctor from the signing of the informed consent form and
             continue throughout the period of taking study treatments and for 3 months after the
             last doses of study drugs.

          -  Patients are willing and able to comply with the protocol for the duration of the
             study including undergoing treatment and scheduled visits and examinations.

          -  Patients in Cohorts A and B must have measurable disease

          -  Patients with glioma or central nervous system (CNS) metastases must be asymptomatic
             and at least 28 days after the most recent CNS treatment and is clinically stable, and
             at least 14 days on stable doses of corticosteroids and/or anti-seizure medications.

        Exclusion Criteria:

          -  Involvement in the planning and/or conduct of the study.

          -  Concurrent enrolment in another clinical study, unless it is an observational
             (non-intervention) clinical study or the follow-up period of an interventional study.

          -  Receipt of any conventional or investigational anticancer therapy within 4 weeks prior
             to the planned first dose of olaparib and durvalumab.

          -  Any previous treatment with PARP inhibitor or PD-1/PD-L1 inhibitors including olaparib
             and durvalumab.

          -  Other malignancy within the last 5 years with exceptions.

          -  Resting ECG with QTc > 470 msec or family history of long QT syndrome.

          -  Patients receiving any systemic chemotherapy or radiotherapy (except for palliative
             reasons) within 4 weeks prior to planned start of study treatment.

          -  Concomitant use of known strong or moderate CYP3A inducers. The required washout
             period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3
             weeks for other agents. This criterion does not apply to patients in Cohort A.

          -  Persistent toxicities caused by previous cancer therapy, excluding alopecia and
             laboratory values listed per the inclusion criteria.

          -  Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features
             suggestive of MDS/AML.

          -  Patients with symptomatic uncontrolled brain metastases.

          -  Major surgery within 2 weeks of starting study treatment. Patients must have recovered
             from any effects of any major surgery to be considered eligible.

          -  Patients considered a poor medical risk due to a serious, uncontrolled medical
             disorder, non-malignant systemic disease or active, uncontrolled infection.

          -  Patients unable to swallow orally administered medication and patients with
             gastrointestinal disorders likely to interfere with absorption of olaparib.

          -  Female patients who are pregnant, lactating, or intend to become pregnant during their
             participation in this study.

          -  Immunocompromised patients.

          -  Patients with a known hypersensitivity to olaparib or durvalumab or any of the
             excipients of the products.

          -  Patients with known active hepatitis (i.e. Hepatitis B or C).

          -  Patients requiring whole blood transfusions in the last 120 days prior to entry to the
             study.

          -  Current or prior use of immunosuppressive medications within 14 days before the 1st
             dose with exceptions.

          -  Active or prior documented autoimmune or inflammatory disorders within the last 2
             years.

          -  History of allogenic organ transplantation.

          -  Any condition that, in the opinion of the investigator, would interfere with
             evaluation of the investigational products or interpretation of patient safety or
             study results.

          -  Prior enrolment in this study.

          -  Receipt of liver attenuated vaccines within 30 days prior to the 1st dose of
             investigational products, during the study and 30 days after the last dose of study
             treatments.

          -  Known active infection including tuberculosis.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Eric Chen, M.D., 416-946-2263, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03991832

Organization ID

19-5526

Secondary IDs

SOLID

Responsible Party

Sponsor

Study Sponsor

University Health Network, Toronto


Study Sponsor

Eric Chen, M.D., Principal Investigator, Princess Margaret Cancer Centre


Verification Date

September 2020