C32001 MLN0128 + MLN1117 in advanced non-haematologic malignancies
Research type
Research Study
Full title
A Multicenter, Open-label, Phase 1b Study of MLN0128 (an Oral mTORC1/2 Inhibitor) in Combination With MLN1117 (an Oral PI3Kα Inhibitor) in Adult Patients With Advanced Nonhematologic Malignancies
IRAS ID
131703
Contact name
Juanita Lopez
Contact email
Sponsor organisation
Millennium Pharmaceuticals
Eudract number
2013-000466-11
Duration of Study in the UK
3 years, 2 months, 1 days
Research summary
This is a phase I study, in which adult patients with advanced solid cancers will be given a combination of two experimental drugs - MLN0128 and MLN1117. Both drugs block the action of 2 different substances that are part of one of the most abnormal networks in cancers that make cancers grow –the PI3K pathway. The drugs have been shown to kill cancer cells in lab experiments and are currently being tested separately in clinical trials. This is the first time that the drugs will be given together. It is thought that if the 2 drugs are combined, they can have a stronger blocking effect on the PI3K pathway.
The purposes of this study are to find out:
The safety and side effects of the 2 drugs given together
The highest safe doses of both drugs when given together
How the body handles the drugs (pharmacokinetics, PK)
What the drug does to the body and cancer cells (pharmacodynamics, PD)The study will be for patients who have no other effective treatments for their cancer and who meet all the criteria needed to take part. There are 2 stages to the study: a Dose Escalation Stage followed by an Expansion Stage. Two different ways of giving the drugs (dosing schedules) will also be tested in Treatment Arms. The drugs will be given in 28 day cycles.
In the Escalation Stage different groups of 3 to 6 patients will get increasing doses of the drugs, in turn. When serious/important side effects are seen at any dose level, this pattern of increasing the dose will stop and the highest doses (maximum tolerated dose, MTD) with NO serious side effects will be selected to test in the Dose Expansion Stage. In the Dose Expansion stage, the MTD in the best schedule, A or B, will be tested in different groups of patients.
Patients taking part in the study will attend the hospital at specific intervals to be monitored for any side effects and will be scanned every 2 cycles to see if they are getting any benefit from the drugs.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/1083
Date of REC Opinion
22 Oct 2013
REC opinion
Further Information Favourable Opinion