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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 : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Redx Pharma Plc

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.

Condition or disease Intervention/treatment Phase
Cancer Solid Tumor Drug: RXC004 Phase 1

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


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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
Primary Purpose: Treatment
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 : March 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
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
Drug: RXC004
RXC004 is taken orally, inhibits porcupine (PORCN) and interacts with the wnt signalling pathway




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

(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

Information from the National Library of Medicine

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


Contacts
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Contact: Dr Andrew Saunders CMO 44(0)1625 469900 a.saunders@redxpharma.com

Locations
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United Kingdom
Royal Marsden Hospital, Institute of Cancer Research Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Dr Juanita Lopez         
Guys Hospital Recruiting
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         
Sponsors and Collaborators
Redx Pharma Plc

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Responsible Party: Redx Pharma Plc
ClinicalTrials.gov Identifier: NCT03447470     History of Changes
Other Study ID Numbers: RXC004/0001
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No