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Study description
The study was done to assess a new anticancer drug combined with a marketed drug in patients who had breast cancer that had spread to other parts of the body.
The current name of the study drug is S81694. MPS1 kinase is an enzyme that controls cell multiplication. S81694 blocks the MPS1 kinase. This leads to the death of cancer cells.
The marketed drug is called paclitaxel. Paclitaxel is used to treat patients who have different types of cancer, including breast cancer. Researchers had expected that S81694 combined with paclitaxel would work better in patients with breast cancer.
The study combined phase 1 and phase 2 studies.
The main objectives of phase 1 were:
- To look at the safety of the study drug.
- To find the highest tolerated dose of treatment, called “Maximum Tolerated Dose (MTD)”. This dose helps to find the recommended dose (dose that is both safe and effective for patients).
The main objective of phase 2 was to assess how the study drug combined with paclitaxel was effective.
English (USA)- Combination therapy (S81694 + paclitaxel) phase I
- Paclitaxel
- Combination therapy (S81694 + paclitaxel) phase II
- CL1-81694-003
Eligibility Criteria
Eligible age for the study
Sex
Male/FemaleAccepts Healthy Volunteers
NoTo take part, participants had to:
- Be 18 years of age or older.
- Be diagnosed with any type of breast tumour that had spread to other parts of the body.
- Have cancer for which standard treatments were no longer effective or unsuitable.
Participants could not take part in the study if:
- They had received any other cancer treatment within 4 weeks before starting the study.
- Their cancer had spread to the brain.
How is the study designed?
Phase I: Participants with metastatic breast cancer received the same treatment. They received S81694 through an IV infusion (injection given slowly) into a vein) every two weeks at different doses on Day 1 and Day 15, for a total of 28 days. The participants also received paclitaxel through an IV on Day 1, Day 8, and Day 15, also for 28 days.
Phase II: Participants with untreated metastatic triple negative breast cancer received paclitaxel through an IV on Day 1, Day 8, and Day 15 at a dose of 80 mg/m² during a 28-day cycle.
Phase II: Participants with untreated metastatic triple negative breast cancer received S81694 through an IV on Day 1 and Day 15 at the recommended dose for Phase II. They also received paclitaxel through an IV on Day 1, Day 8, and Day 15 during a 28-day cycle.