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A Phase I Dose Escalation Study Evaluating MK1775 in Both Monotherapy and in Combination With Either Gemcitabine, Cisplatin, or Carboplatin in Adult Subjects With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

Thank you

Trial Information

A Phase I Dose Escalation Study Evaluating MK1775 in Both Monotherapy and in Combination With Either Gemcitabine, Cisplatin, or Carboplatin in Adult Subjects With Advanced Solid Tumors

Inclusion Criteria:

- Subject must have a histologically confirmed metastatic or locally advanced solid
tumor, progressed despite standard therapy, or for which standard therapy does not

- Subject is at least 18 years old

- Subject must have performance status of <=1 on the ECOG Performance Scale

- Female subjects must not be pregnant

Exclusion Criteria:

- Subject has had chemotherapy, radiotherapy, or biological therapy within 4 weeks
prior to entering the study or who has not recovered from adverse events due to
agents given more than 4 weeks earlier

- Subject is participating or has participated in a study with an investigational
compound or device within 30 days

- Subjects with active CNS metastases and/or carcinomatous meningitis are excluded.
However, subjects with CNS metastases who have completed a course of therapy would be
eligible for the study provided they are clinically stable for 1 month prior to entry

- Subject with a primary central nervous system tumor

- Subject is allergic to any of the components of the combination study therapy or its

- Participant has had prescription or non-prescription drugs or other products known to
be metabolized by CYP3A4 that cannot be discontinued prior to Day 1 of dosing and
withheld throughout the study until 2 weeks after the last dose of study medication.
Medications of particular concern are inhibitors of CYP3A4 (azole antifungals
[ketoconazole, itraconazole], macrolide antibiotics [erythromycin, clarithromycin],
cimetidine, aprepitant, HIV protease inhibitors, nefrazodone, and the following
inducers of CYP3A4: phenytoin, barbiturates and rifampicin, and substrates of CYP3A4
including statins (lovastatin, simvastatin), midazolam, terfenadine, astemizole, and

- Subject is a regular user (including "recreational use") of any illicit drugs or had
a recent history (within the last year) of drug or alcohol abuse

- Subject is pregnant or breastfeeding, or expecting to get pregnant during the time
the study will be ongoing

- Subject is (HIV)-positive

- Subject has a history of Hepatitis B or C

- Subject has symptomatic ascites or pleural effusion. A subject who is clinically
stable following treatment for these conditions is eligible

- Subject must not have prior radiation therapy to more than 30% of the bone marrow and
must have recovered for at least 3 weeks from the hematologic toxicity of prior

- Subject has had a prior stem cell or bone marrow transplant

- Subject has received more than 4 prior cytotoxic chemotherapy regimens

- Participant has a history suggestive of Li-Fraumeni Syndrome

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with dose limiting toxicities

Outcome Time Frame:

Cycle 1 (14 days for monotherapy and 21-28 days for combination therapy)

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

January 2014

Related Keywords:

  • Solid Tumors
  • Neoplasms



Call for Information (Investigational Site 0009) Santa Monica, California  90404
Call for Information (Investigational Site 0003) Boston, Massachusetts  02115