Clinical trial NCT00543387: Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001)
Official title: A Phase I Investigation of MK-5108 and MK-5108 With Docetaxel in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer, Neoplasms, Tumors
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety, side effects and how well the body tolerates MK-5108 as well as determine different doses of MK-5108 in participants with advanced and/or refractory solid tumors. The corresponding primary hypotheses of this study are that 1) administration of oral MK-5108 (twice daily for 2 out of 14-21 days) to participants with advanced and/or refractory solid tumors will be safe and tolerable, and that 2) the spectrum of side effects observed in these participants after administration of oral MK-5108 alone and in combination with docetaxel will be dose-dependent and allow for definition of a maximum tolerated dose (MTD).


Eligibility criteria: Inclusion Criteria:

- Participant has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy or progressed with standard therapy

Exclusion Criteria:

* Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks prior to study start or has not recovered from adverse events caused by therapy more than 4 weeks earlier
* Participant is currently participating or has participated in a study with an investigational compound or device within 4 weeks prior to signing informed consent
* Participant has received more than 2 courses of chemotherapy for metastatic disease
* Participant has had prolonged neutropenia or neutropenia with fever from previous chemotherapy treatment
* Participant has a primary central nervous system tumor
* Participant is a regular or recreational user of any illicit drugs or has a recent history within the last year of drug or alcohol abuse
* Participant is pregnant, breastfeeding or planning to have children during the study
* Participant is Human Immunodeficiency Virus (HIV) positive
* Participant has a history of Hepatitis B or C

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: From Day 1 of study treatment until 30 days following the last dose of study treatment (up to 577 days)
measure: Number of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: Day 1 to Day 21 of study treatment (Cycle 1 for Panel 1, Panel 2, or Crossover)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Amin M, Minton SE, LoRusso PM, Krishnamurthi SS, Pickett CA, Lunceford J, Hille D, Mauro D, Stein MN, Wang-Gillam A, Trull L, Lockhart AC. A phase I study of MK-5108, an oral aurora a kinase inhibitor, administered both as monotherapy and in combination with docetaxel, in patients with advanced or refractory solid tumors. Invest New Drugs. 2016 Feb;34(1):84-95. doi: 10.1007/s10637-015-0306-7. Epub 2015 Dec 1.