EUCTR2016-001202-42-HUActive, not recruitingPhase 1
A Phase II, Open-Label, Multi-Arm Study to Determine the PreliminaryEfficacy of Novel Combinations of Treatment in Patients with PlatinumRefractory Extensive-Stage Small-Cell Lung Cancer
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion criteria (applicable to all arms)
- •-Adults with ED SCLC who have have demonstrated progressive disease either during first-line platinum-based chemotherapy (platinum refractory) or within 90 days of completing platinum based-chemotherapy (platinum resistant) and have not received further treatment.
- •-Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
- •-At least 1 lesion, not previously irradiated, that can be accurately measured at baseline.
- •-Life expectancy of at least 8 weeks.
- •-Adequate organ and marrow function
- •-WHO/ECOG PS of 0-1 at enrollment
- •Inclusion criteria (Arm A specific)
- •-Body weight >30 kg.
- •-No prior exposure to immune mediated therapy, excluding therapeutic anticancer vaccines.
- •Inclusion criteria (Arm B specific)
- •-Able and willing to swallow oral medication
- •Inclusion Criteria (Arm C specific)
- •-Able and willing to swallow oral medication
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
Exclusion Criteria
- •Exclusion criteria (applicable to all arms)
- •-Participation in another clinical study, major surgery, radiation therapy within 28 days.
- •-Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of patient safety or study results.
- •-History of ILD, another primary malignancy, leptomeningeal carcinomatosis or spinal cord compression
- •Exclusion criteria (Arm A specific)
- •-Any concurrent cancer treatment.
- •-Live vaccines within 30 days.
- •-Known hypersensitivity to IP or excipient.
- •-Prior randomization or treatment in a previous durvalumab and/or tremelimumab clinical study.
- •-Active autoimmune disease, including a paraneoplastic syndrome of autoimmune nature.
- •-Active or prior documented autoimmune or inflammatory disorders.
- •-Any unresolved toxicity (CTCAE Grade >2) from previous anticancer therapy.
- •-History of allogenic organ transplantation or active primary immunodeficiency.
- •-Active infection.
- •-Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab.
- •Exclusion criteria (Arm B specific)
- •-Prior exposure to any WEE1 inhibitors.
- •-Products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4. Coadministration of rosuvastatin, aprepitant or fosaprepitant or any herbal preparations.. Grapefruit and Seville oranges should be avoided while taking AZD1775.
- •-Any known hypersensitivity or contraindication to IP or CBDP.
- •-QTcF > 470 msec or congenital long QT syndrome.
- •-Any current or within 6 months cardiac diseases NYHA = Class 2: unstable angina pectoris, congestive heart failure, acute MI, conduction abnormality not controlled with pacemaker or medication, significant ventricular or supraventricular arrhythmias.
- •-A recent history of Torsades de pointes
- •Exclusion criteria (Arm C specific)
- •- Cytotoxic chemotherapy within 21 days of Cycle 1 Day 1 is not permitted
- •- Previous treatment with a PARP inhibitor (including olaparib) or ATR inhibitor
- •- Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors
- •- Concomitant use of known strong or moderate CYP3A inducers
- •- Persisting (> 4 weeks) severe pancytopenia due to previous therapy
- •- Cardiac dysfunction
- •- Refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection
- •- Patients with uncontrolled seizures
- •- Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the dosing.
Investigators
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