A Cancer Research UK Phase I Trial of an Oral Notch Inhibitor (MK-0752) in Combination With Gemcitabine in Patients With Stage III and IV Pancreatic Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Cancer Research UK
- Enrollment
- 44
- Locations
- 10
- Primary Endpoint
- Adverse event and severity according to NCI CTCAE Version 4.02
Study Overview
Brief Summary
RATIONALE: MK0752 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving MK0752 together with gemcitabine hydrochloride may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of giving MK0752 together with gemcitabine hydrochloride and to see how well it works in treating patients with stage III or IV pancreatic cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES:
Primary
- To determine the recommended phase II dose of MK0752 in combination with gemcitabine hydrochloride in patients with unresectable stage III and IV pancreatic cancer. (Phase I)
Secondary
- To evaluate tumor response in patients treated with this regimen.
- To determine the time to disease progression and 6 months and 1-year survival.
- To determine the percentage of change in CA19-9 levels.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Adverse event and severity according to NCI CTCAE Version 4.02
Maximum-tolerated dose of MK0752 in combination with gemcitabine hydrochloride OR the single agent recommended Phase II dose in combination with either 800 mg/m² or 1000 mg/m² as agreed by DDO and clinicians
Secondary Outcomes
- Plasma concentrations of MK0752
- Percentage change in CA19-9 levels
- Complete response, partial response, or stable disease as defined by RECIST criteria
- Progression-free survival
- Survival at 1 year