Phase I Study of AZD5363 + Olaparib + Durvalumab in Patients With Advanced or Metastatic Solid Tumor Malignancies

Summary

Participation Requirements

Description

This study is divided into 3 different periods: Screening, Treatment, and End of Treatment Before taking the treatment, patients will have some tests and procedures done to make sure they are eligible for the study (Screening). Then they will enter the Treatment period, where Durvalumab, Olaparib an...

This study is divided into 3 different periods: Screening, Treatment, and End of Treatment Before taking the treatment, patients will have some tests and procedures done to make sure they are eligible for the study (Screening). Then they will enter the Treatment period, where Durvalumab, Olaparib and AZD5363 will be administered to them. If they stop taking your study medication for any reason, an End of Treatment visit will be conducted within 30 days after the last doze of study medication. Screening Assessment: Written Informed Consent Inclusion/Exclusion Criteria Complete Medical History Prior therapies and PFS on last anti-cancer therapy Complete Physical Examination amp; ECOG Standard Clinical Neurologic Examination BSA Weight Blood Pressure, Pulse and Temperature Oxygen Saturation (Pulse Oximetry) 12-lead Electrocardiogram HbA1c and fasting glucose Serum Chemistry (renal panel 2) amp; Serum Troponin Level Amylase and lipase Liver function test Serum Pregnancy Test (for women of childbearing potential) Thyroid function test including TSH and free T4 Coagulation Parameters Chest X-ray (if clinically indicated) CBC with Differential CT or MRI Scan Tumor Measurement PET-CT/PET-MRI Scan Tumor Measurement (optional) Transthoracic Echo/ MUGA Baseline Symptoms Concomitant Medication Assessments Tumor Biopsy Fasting lipids Assessment for hepatitis B surface antigen, hepatitis C antibodies and HIV antibodies Urinalysis Run-in Period (Day -14 until Day 0) Complete or Symptom Directed Physical Examination amp; ECOG Standard Clinical Neurologic Examination BSA Weight Blood Pressure, Pulse and Temperature 12-lead Electrocardiogram Serum Chemistry (renal panel 2) Serum Troponin Level Coagulation Parameters Liver panel including amylase and lipase CBC with Differential Oxygen Saturation (Pulse Oximetry) Drug Administration only for AZD5363 Pharmacodynamics (PDn) blood AE Assessments Concomitant Medication Assessments Cycle 1 (every week) Complete or Symptom Directed Physical Examination amp; ECOG Standard Clinical Neurologic Examination BSA Weight Blood Pressure, Pulse and Temperature HbA1c ( To be performed on cycle 1 day 1and every 12 week thereafter) 12-lead Electrocardiogram Serum Chemistry (renal panel 2) Serum Troponin Level Coagulation Parameters Liver panel including amylase and lipase CBC with Differential Thyroid Stimulating Hormone (TSH), ACTH (only every 4 weeks, D1 of every cycle) Oxygen Saturation (Pulse Oximetry) Drug Administration Pharmacodynamics (PDn) AE Assessments Concomitant Medication Assessments Urinalysis Cycle 2 and Cycle 3 (every 2 weeks) Complete or Symptom Directed Physical Examination amp; ECOG Standard Clinical Neurologic Examination BSA Weight Blood Pressure, Pulse and Temperature 12-lead Electrocardiogram Serum Chemistry (renal panel 2) Liver panel including amylase and lipase Serum Troponin Level Coagulation Parameters CBC with Differential Oxygen Saturation (Pulse Oximetry) Drug Administration Pharmacodynamics (PDn) blood (Cycle 2 Day 1) AE Assessments *CT or MRI Scan Tumor Measurement (end of Cycle 2every 8 weeks in the last week of the cycle) Concomitant Medication Assessments Fasting lipids Urinalysis Transthoracic Echo/ MUGA (only if indicated) Cycle 4 and Beyond (every 4 weeks) Complete or Symptom Directed Physical Examination amp; ECOG Weight Blood Pressure, Pulse and Temperature Standard Clinical Neurologic Examination Oxygen Saturation (Pulse Oximetry) 12-lead Electrocardiogram Transthoracic Echo/ MUGA (only at C4D1) Fasting lipids Serum Chemistry (renal panel 2) Serum Troponin Level Thyroid Stimulating Hormone (TSH), ACTH Coagulation Parameters CBC with Differential *CT or MRI Scan Tumor Measurement (end of Cycle 4 and every 8 weeks thereafter) Drug Administration *PET-CT/PET-MRI Scan Tumor Measurement (optional) (every 8 weeks) AE Assessments Concomitant Medication Assessments Transthoracic Echo/ MUGA (only if indicated) Final Visit Complete Physical Examination amp; ECOG Weight Blood Pressure, Pulse and Temperature Standard Clinical Neurologic Examination Oxygen Saturation (Pulse Oximetry) 12-lead Electrocardiogram and troponin level Transthoracic Echo/ MUGA Fasting lipids Serum Chemistry Coagulation Parameters CBC with Differential Thyroid Stimulating Hormone (TSH) AE assessments Concomitant Medication Assessment

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