Actively Recruiting
Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors
Led by University Health Network, Toronto · Updated on 2024-07-18
58
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent before any study procedures
- Be 18 years or older
- Weigh more than 30 kg
- For Cohort A: Have confirmed IDH-mutated diffuse astrocytic or oligodendroglial tumors with no more than 2 prior systemic therapies after relapse
- For Cohort B: Have confirmed IDH-mutated biliary tract adenocarcinoma with no more than 2 prior systemic therapies for advanced disease
- Have normal organ and bone marrow function within 28 days before treatment
- Have ECOG performance status of 0 or 1
- Have a life expectancy of at least 16 weeks
- Agree to use pregnancy prevention methods during and for 3 months after treatment
- Be willing and able to follow the study protocol including visits and treatments
- Have measurable disease
- If glioma or CNS metastases, be asymptomatic, clinically stable, at least 28 days post CNS treatment, and on stable corticosteroid/anti-seizure doses for at least 14 days
You will not qualify if you...
- Involvement in planning or conducting the study
- Enrollment in another interventional clinical study (observational studies allowed)
- Receipt of any anticancer therapy within 4 weeks before starting study drugs
- Prior treatment with PARP inhibitors or PD-1/PD-L1 inhibitors including olaparib or durvalumab
- Other cancers within the last 5 years except certain exceptions
- Resting ECG with QTc over 470 msec or family history of long QT syndrome
- Systemic chemotherapy or radiotherapy within 4 weeks before study treatment (except palliative)
- Use of strong or moderate CYP3A inducers (with exceptions for Cohort A)
- Persistent toxicities from previous cancer therapy (excluding alopecia and specified labs)
- History or features of myelodysplastic syndrome or acute myeloid leukemia
- Symptomatic uncontrolled brain metastases
- Major surgery within 2 weeks before starting treatment
- Serious uncontrolled medical conditions or infections
- Inability to swallow oral medication or gastrointestinal issues affecting absorption
- Pregnant, lactating, or intending pregnancy during the study
- Immunocompromised status
- Known allergy to olaparib, durvalumab, or their ingredients
- Known active hepatitis B or C
- Blood transfusions in the last 120 days
- Use of immunosuppressive medications within 14 days before first dose (with exceptions)
- Active or recent autoimmune or inflammatory disorders within 2 years
- History of allogenic organ transplantation
- Any condition interfering with evaluation or safety
- Prior enrollment in this study
- Receipt of live attenuated vaccines within 30 days before, during, or 30 days after treatment
- Known active infections including tuberculosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
E
Eric Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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