I239

I239 Details
Status: Closed
Activation Date: 2019DEC19
Closing Date: 2022APR26
Phase: II

Description: A Phase II Study of CFI-400945 and Durvalumab in Patients with Advanced/Metastatic Triple Negative Breast Cancer (TNBC)

Eligibility: Histologically and/or cytologically confirmed diagnosis of breast cancer that is advanced/metastatic or unresectable and negative for ER, PR and HER2. FFPE tissue block available; select number of patients must have accessible disease suitable for biopsy. Presence of clinically/radiologically documented disease. ECOG 0 or 1. At least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, must have included anthracycline and taxane. No limit to number of prior regimens. May have received other therapies (i.e. endocrine therapy, targeted therapies). Must not have received prior immunotherapy. Not permitted: Active or uncontrolled infections, active or prior autoimmune or inflammatory disorders, primary immunodeficiency or allogenic organ transplant, serious illness, untreated or uncontrolled cardiovascular conditions, history of CNS mets or spinal cord compression; concurrent treatment with other investigational drugs, treated with full dose warfarin or growth factors.

Objective: Primary Objectives: To evaluate the objective response rate (RECIST 1.1) of CFI-400945 given with durvalumab. Secondary Objectives: To evaluate Disease Control Rate (DCR, defined as CR or PR or stable disease (SD) > 16 weeks in duration) of CFI-400945 given with durvalumab, to evaluate the immune-related response rate (iRECIST) of CFI-400945 given with durvalumab, to establish the safety and tolerability of CFI-400945 given orally in combination with durvalumab in a q4w schedule and to confirm the recommended phase II dose (RP2D) in patients with metastatic triple negative breast cancer (TNBC), and to assess the pharmacodynamic and immune effects of CFI-400945+durvalumab.

Participation: Limited to invited centres

Lay Description: The purpose of this study is to find out the effect that CFI-400945 and durvalumab have on breast cancer that is advanced or metastatic (has spread to other parts of the body), which does not express receptors ("triple negative") and for which no curative therapy exists.

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Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
IND	I239	15	9	15	15

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(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
IND	I239	15	0	0

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Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
IND	I239	15	0	0	0	0	0	0	0	0