*ASTX029 in Advanced Solid Tumours
Research type
Research Study
Full title
A Phase 1-2 Study of the Safety, Pharmacokinetics, and Activity of ASTX029 in Subjects With Advanced Solid Tumors
IRAS ID
290662
Contact name
Matthew Krebs
Contact email
Sponsor organisation
Astex Pharmaceuticals, Inc.
Eudract number
2018-004568-72
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 134813
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
There are around 367,000 new cancer cases in the UK every year. Over the last decade, incidence rates for all cancers combined have increased by a twentieth (5%) in the UK.
Historically, medical approaches to treat advanced cancers have typically involved surgery, radiotherapy, and/or chemotherapy. Scientific advances have led to successful development of therapies targeting specific mutations in cancer cells. More recently, cancer immunotherapy has also been shown to significantly improve the outcomes of many cancers. However, a significant proportion of patients eventually relapse. There is an unmet need for new approaches to stop the uncontrolled growth of cancer cells in patients whose tumours have progressed despite currently available treatments.
ASTX029 has been shown to help slow the growth of some tumours in laboratory tests. The purpose of this study is to determine the best dose to use for treating patients and if the medication is effective in patients who are not eligible for other approved treatments.
The study will enrol participants who have tumours with specific gene mutations that may make them more sensitive to the medication. The study medication will be taken once a day and participants will be required to fast for four hours when taking their medication.
Participants may continue to receive study medication for as long they receive benefit from it, until a decision is made to stop the treatment.
It is anticipated that up to 300 participants will be enrolled in this study.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0190
Date of REC Opinion
21 Apr 2021
REC opinion
Further Information Favourable Opinion