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Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03447470
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Redx Pharma Plc

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE February 27, 2018
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE March 18, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
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. AE's will be collected until 30 days after stopping drug ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • Part A [ Time Frame: 0.5hr, 1hr, 2hr, 4hr, 6hr, 8-10hr, 24hr at Cycles (Cy) - Cy0D1, Cy1D1, C1D8, C2D1, C3D1-C6D1) ]
    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.
  • Part A [ Time Frame: 0.5hr, 1hr, 2hr, 4hr, 6hr, 8-10hr, 24hr at Cycles (Cy) - Cy0D1, Cy1D1, C1D8, C2D1, C3D1-C6D1) ]
    Characterise the PK profile to following single dose and at steady state and after multiple dose. Plasma clearance at steady state. Maximum Plasma Concentration Cmax (tmax). C24. C12. Terminal Rate Constant. Terminal Half Life. Area of Plasma concentration-time curve (AUC0-24).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies
Official Title  ICMJE 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
Brief Summary The purpose of Part A of this study is to determine the safety and tolerability of RXC004 in patients with advanced malignancies. In order to define the doses and schedules for further clinical evaluation.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Dose escalation
Masking: None (Open Label)
Masking Description:
Open label design
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Solid Tumor
Intervention  ICMJE Drug: RXC004
RXC004 is taken orally, inhibits porcupine (PORCN) and interacts with the wnt signalling pathway
Study Arms  ICMJE 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
Intervention: Drug: RXC004
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

(Summarized due to limitation of characters)

Inclusion Criteria:

  • Written informed consent
  • Aged at least 18 years
  • Histological or cytological confirmation of advanced malignancy not considered to be appropriate for further conventional treatment
  • Patients must use adequate contraception measures for the duration of the study and for 6 months after the study
  • Patients must have adequate organ functions
  • Ability to swallow and retain oral medication

Exclusion Criteria:

  • Prior treatment with a compound of the same mechanism of action as RXC004
  • No other anti-cancer therapy or investigational product throughout the study
  • Patients with persistent grade 2 or higher diarrhoea
  • Patients at high risk of bone fractures
  • QTc prolongation
  • Known uncontrolled intercurrent illness
  • Known severe allergies to any active or inactive ingredients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dr Andrew Saunders CMO 44(0)1625 469900 a.saunders@redxpharma.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03447470
Other Study ID Numbers  ICMJE RXC004/0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Redx Pharma Plc
Study Sponsor  ICMJE Redx Pharma Plc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Redx Pharma Plc
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP