Solid Tumor
A Phase I Study of Single-agent MK-1775, a Wee1 Inhibitor, in Patients With Advanced Refractory Solid Tumors
NCI-13-C-0032, NCT01748825
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Investigator(s): |
Shivaani Kummar, M.D., F.A.C.P. Principal Investigator Phone: 301-435-0517 Fax: 301-496-0826 kummars@mail.nih.gov
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Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 Fax: 301-451-5433 jbingham@mail.nih.gov
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Lemual Clayborn Referral Coordinator Phone: 301-451-0992 Fax: 301-496-0826 claybornlr@mail.nih.gov
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Jennifer Zlott, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-435-5664 Fax: 301-480-7281 zlottjh@mail.nih.gov
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Key Eligibility Criteria:
- Histologically confirmed solid tumors for which all standard therapy known to prolong survival has failed or for which standard therapies do not exist
- Measurable disease or evaluable disease
- ECOG ≤ 2 (Karnofsky > 60 percent)
- Normal organ and marrow function
- Able to swallow whole tablets or capsules
- Not pregnant or nursing
- Agrees to use adequate contraception prior to the study, for the duration of study participation, and 2 months after completion of MK-1775 administration
- No uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Study Outline:
- Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
- Participants will take MK-1775 by mouth for 21-day cycles of treatment; two doses on Day 1, two doses on Day 2, and one on Day 3, with no treatment for the remaining days
- Participants will keep a study diary to record their doses and any side effects
- Some participants will have 2 weeks of MK-1775 for each cycle( Days 1–3 and Days 8–10)
- Cycles repeat every 21 days for as long as there is no progressive disease or unacceptable toxicity
- Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed:
Updated: 1/10/13