Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT03447470|
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer Solid Tumor||Drug: RXC004||Phase 1|
Part A of the study will consist of an ascending monotherapy dose, the doses are pre-defined.
The decision to escalate will be made upon the assessment of safety and tolerability data in the first cycle of treatment.
Part A - Module 1 will commence with an accelerated dose escalation schedule and enrol one (1) patient into a cohort with follow up for adverse events and dose limiting toxicities.
Once a Minimal Biologically Active Dose (MBAD) has been found to be tolerated, dose escalations will continue in a 3+3 design to further characterise the PK profile, Maximum Tolerated Dose and Maximum Feasible Dose.
Part B study design will be adapted based on the emerging data from Part A
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Dose escalation|
|Masking:||None (Open Label)|
|Masking Description:||Open label design|
|Official Title:||A Modular, Multi-arm, Multi-part, Phase 1/2a, Adaptive Design Study to Evaluate the Safety and Tolerability of RXC004, Alone and in Combination With Other Anti Cancer Treatments, in Patients With Advanced Malignancies|
|Actual Study Start Date :||March 18, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Module 1, Part A
Patients will be given RXC004 at a specified dose level and reviewed for Dose Limiting Toxicities Once the DLT period is complete RXC004 will be given at a higher dose until MTD
RXC004 is taken orally, inhibits porcupine (PORCN) and interacts with the wnt signalling pathway
- Part A - Safety and Tolerability of RXC004 by assessment of whether any Dose Limiting Toxicities (DLT) arise from first dose until the end of 21 days of continuous dosing [ Time Frame: The DLT period will be assessed from the first dose until the end of 21 days of continuous dosing. This will be completed for each dose level until a Maximum Tolerated Dose (MTD) is identified. Estimated time 12 Months in total ]A DLT is defined as an adverse event or abnormal laboratory value. Haematological toxicity of CTCAE grade 4 for more than 4 consecutive days. Grade 3 neutropenia of any duration accompanied by fever >38.5 degrees Celsius. Grage 3 thrombocytopaenia with bleeding. Any other confirmed haematological toxicity >CTCAE grade 4. Non-haematological toxicity >CTCAE grade 3. Any other toxicity that is judged to be a DLT by the Safety Review Committee. An AE resulting in disrupted dosing >14 days.
- Part A [ Time Frame: Throughout the study and at study completion (approximately 1 year for Part A) ]Characterise the PK profile to following single dose and at steady state and after multiple dose. Cmax at steady state, time to Cmax, minimum concentration at steady state.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447470
|Contact: Dr Andrew Saunders CMO||44(0)1625 firstname.lastname@example.org|
|Royal Marsden Hospital, Institute of Cancer Research||Recruiting|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Contact: Dr Juanita Lopez|
|London, United Kingdom, SE1 9RT|
|Contact: Dr Debashis Sarker|
|The Christie NHS Foundation Trust||Recruiting|
|Manchester, United Kingdom, M20 4BX|
|Contact: Dr Natalie Cook|
|Sir Bobby Robson Cancer Trials Research Centre||Recruiting|
|Newcastle, United Kingdom, NE77DN|
|Contact: Dr Ruth Plummer|
|Department of Oncology||Recruiting|
|Oxford, United Kingdom, OX3 7LE|
|Contact: Dr Sarah Blagden|