VX-803-001 in Subjects With Advanced Solid Tumours or Lymphoma
Research type
Research Study
Full title
An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-803/M4344 as a Single Agent and in Combination with Cytotoxic Chemotherapy in Subjects with Advanced Solid Tumors
IRAS ID
171636
Contact name
Johann de Bono
Contact email
Sponsor organisation
EMD Serono/ Merck KGaA
Eudract number
2014-003838-86
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 123360
Duration of Study in the UK
1 years, 9 months, 29 days
Research summary
Research Summary
Phase 1 first in human study of VX-802 in combination with Carboplatin in advanced solid tumours or lymphoma, dose escaltion study:
Part A-(20 subjects) to evaluate the safety and tolerability of multiple ascending doses of single-agent VX-803 administered orally twice-weekly (BIW) and to determine the maximum tolerated dose (MTD). Participation could last for approximately 11 weeks, or until the tumour grows, including a 3-week screening window and 2-week follow up period.
Part B (15 subjects)-to evaluate the safety and tolerability of VX-803 (orally) in combination with carboplatin (intra-venous infusion) and to determine the MTD. Participation could last for approximately 23 weeks, or until the tumour grows, including a 3-week screening window and 2-week follow up period.
Part C (20 subjects)-to evaluate the safety and tolerability of VX-803 (orally) in combination with carboplatin (intra-venous infusion) in platinum-refractory, or platinum-resistant advanced serous ovarain cancer. Participation could last for approximately 23-28 weeks, or until the tumour grows, including a 3-week screening window and 2-4 week follow up period. If subjects take part in the food effect Study, they will have a 2 week screening period, and one week sub-study of the effect of food before starting the regular cycle 1 schedule.
Male and Female subjects of at least 18 yrs of age with tumour measurable by RECIST 1.1. Parts A & B:Advanced solid tumours or lymphoma, Part C:Advanced serous ovarian cancer. Subjects will take part in Part A or B or C.
The following tests will be performed, CT scans, Bone Scans, PET scans and Tumour biopsy (if required), Electrocardiograph (ECG), Echocardiogram, Vital signs, Blood, Urine and hair follicle sampling.Summary of Results
The results were released to EudraCT and Ct.gov registries on 24May2022. As it is Phase 1 study, results on EudraCT will not be visible online. Once Protocol Registration and Results System (PRS) review is complete, results of the study along with redacted protocol and SAP will be visible online on Ct.gov.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0344
Date of REC Opinion
27 Apr 2015
REC opinion
Further Information Favourable Opinion