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A Phase I Investigation of MK-5108 and MK-5108 With Docetaxel in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Cancer, Neoplasms, Tumors

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Trial Information

A Phase I Investigation of MK-5108 and MK-5108 With Docetaxel in Patients With Advanced Solid Tumors

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants who experience an adverse event

Outcome Time Frame:

From Day 1 of study treatment until 30 days following the last dose of study treatment

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

April 2011

Related Keywords:

  • Cancer, Neoplasms, Tumors
  • Neoplasms