A Dose Escalation Study of MK1775 in Combination With Either Gemcitabine, Cisplatin, or Carboplatin in Adults With Advanced Solid Tumors (MK-1775-001 AM7)
Status: | Completed |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/16/2013 |
Start Date: | February 2008 |
End Date: | January 2014 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
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
This study will investigate MK1775 alone and in combination with one of the following three
drugs: gemcitabine, cisplatin, and carboplatin in patients with advanced solid tumors. The
purpose of the study is to test safety and tolerability of MK1775 alone and in combination,
and to find the maximum tolerated dose (MTD) of MK1775 as monotherapy and in combination
therapy.
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
exist
- 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
analogs
- 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
cisapride
- 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
radiotherapy
- 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
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