Status: Closed
Activation Date: 2016MAY16
Closing Date: 2019NOV25
Phase: I
Description: A Phase I Study of CX5461
Eligibility: All patients: Age >=18 years. ECOG 0, 1, or 2. Must have an available tissue block. Adequate organ function. Patients must not have known photosensitivity disorders, and must agree to use adequate sun protection and avoid tanning booths. No active infections or untreated/uncontrolled cardiovascular conditions. Phase I: Patients with histologically and/or cytologically confirmed solid malignancy. No limit to the number of prior cytotoxic or other systemic therapy regimens. Phase II: Patients must have triple negative breast cancer or must have BRCA1/2 or HRD germline or somatic aberrations (known, or documented during pre-enrolment screening). Must provide consent for a whole blood sample. At least 6 patients in each cohort must provide consent for a tumour and skin biopsy prior to and on treatment. Must have received at least one but no more than 3 prior cytotoxic therapy regimens. No limit to the number of prior other systemic therapy regimens, but prior PARP inhibtors not allowed.
Objective: Phase I: Primary - To determine the recommended phase II dose (RP2D) and schedule of CX5461 in patients with solid tumours. Secondary - To establish the safety and tolerability of CX5461 given intravenously to patients with solid tumours; To determine the pharmacokinetics of CX5461 given intravenously in patients with solid tumours. Exploratory - To explore the relationship between germline HRD aberrations and outcomes of CX5461. Phase II: Primary - To evaluate anti-tumour activity assessed by response rate (RR) in each cohort. Secondary - To estimate the progression free survival (PFS) rate at 6 months in each cohort; To assess the safety and toxicity profile of CX5461. Exploratory - To evaluate predictive biomarkers of response to CX5461; To evaluate pharmacodynamic biomarkers of response to CX5461 using ctDNA (all patients) and paired biopsies (selected patients); To explore the relationship between germline HRD aberrations and outcomes of CX5461.
Participation: Limited to invited centres
Lay Description: This is a phase I study in patients with solid tumours and breast cancer. The purpose of this study is to find the dose of a new therapy, CX5461, that can be tolerated without causing very severe effects and to see what effects the study drug has on a patients cancer. Additional research will investigate the effects CX5461 has on cancer cells, as well as explore the relationship between certain tumour DNA abnormalities and outcomes of CX5461 treatment.
Primary Publication Show
Other Publications Show
Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I231 | 41 | 15 | 34 | 36 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I231 | 41 | 1 | 2 |
| 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 | I231 | 41 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |