Phase I Open-Label Dose Escalation Study in Myeloma; GMI-1271-230 v6.0
Research type
Research Study
Full title
A Phase I Open-Label Dose Escalation Study to Determine the Efficacy, Safety and Pharmacokinetics of GMI-1271 as Adjunct to Standard of Care Chemotherapy for the Treatment of Multiple Myeloma
IRAS ID
224373
Contact name
Gordon Cook
Contact email
Sponsor organisation
GlycoMimetics, Inc.
Eudract number
2015-003158-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
This is a Phase I multi-center, open-label dose escalation trial of the efficacy, safety and PK of GMI-1271 given with standard of care chemotherapy in adults with multiple myeloma (MM). The study medication, GMI-1271, is experimental, which means that it has not been approved for use by any regulatory authorities. GMI-1271 is being developed to treat different types of cancers which primarily affect the blood.
The research purposes of this study are to:
• Learn about the safety of GMI-1271 when given to patients receiving standard of care chemotherapy medicines (bortezomib or carfilzomib) used to treat Multiple Myeloma
• Learn about the efficacy of GMI-1271 when given to patients receiving standard of care chemotherapy medicines used to treat Multiple Myeloma
• Determine how much GMI-1271 is in the blood of participants after taking this study medication
• Measure if GMI-1271 has an effect on cancer (Multiple Myeloma) cells found in the blood and bone marrow
Subjects will receive 1 to 6 months of treatment with an additional 18 months of observation.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0205
Date of REC Opinion
24 Jul 2017
REC opinion
Further Information Favourable Opinion