Trial to Study the Safety of Intravenous MNK-010 in Advanced Solid Tumors
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT02040558
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-393
This is a multicenter, open-label, dose escalation study of MNK-010 in subjects with advanced solid malignancies who have failed conventional therapy. The safety, tolerability, pharmacokinetic (PK) profile, and preliminary antitumor activity of ascending doses of MNK-010 will be evaluated in subjects with advanced solid tumors.
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center
Geoffrey Shapiro, MD, PhD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
Andrew Wolanski, 617-632-6623,
1. Diagnosis of an advanced solid tumor malignancy.
2. Histological or cytological evidence of malignancy.
3. Advanced malignancy, metastatic or unresectable, that has recurred or progressed
following standard therapy or failed standard therapy; or for which no standard
therapy currently exists, or for which subject is not a candidate for, or is
unwilling to undergo, standard therapy.
4. Disease that is currently not amenable to curative surgical intervention.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and a life
expectancy > 12 weeks.
6. Subject (and/or parent/guardian for subject who otherwise is unable to provide
independent consent, if acceptable to and approved by the site and/or site's IRB)
must be willing to give written informed consent and be able to adhere to dose and
7. 18 years or older, of either sex, and of any race
8. Female subjects of childbearing potential must have negative pregnancy test within 7
days prior to first dose of study drug; practicing an acceptable form of birth
control for greater than 2 months prior to screening and commits to use for the
duration of the study and for 3 months following the last dose of study treatment.
9. Male subjects must be sterile (biologically or surgically) or commit to the use of a
reliable method of birth control for the duration of the study until at least 3
months after the last dose of study treatment in such a manner that the risk of
pregnancy for a partner is minimized.
10. Prior to study treatment administration, at least 21 days must have elapsed since the
subject's prior investigational or non-investigational systemic therapy, or any major
surgery, and at least 21 days since prior radiotherapy.
11. Subjects with a history of prior radiotherapy are eligible if they meet the following
parameters: Prior to study treatment administration, must be ≥ 21 days post-therapy
and have recovered from all toxicities; must have evidence of measurable disease
outside the radiation fields or radiologically confirmed progression of disease; must
not have had > 25% of their functional bone marrow irradiated. Must have
radiologically measureable disease, a life expectancy > 12 weeks, and adequate organ
1. Subject has received any chemotherapy, immunotherapy, vaccines, monoclonal
antibodies, whether conventional or investigational, major surgery within 21 days, or
radiotherapy within 21 days of treatment in this study, or at any time during the
2. Subject has an active, uncontrolled systemic infection considered opportunistic,
life-threatening, or clinically significant at the time of treatment.
3. Subject has symptomatic or untreated central nervous system (CNS) metastases; any
type of active seizure disorder; febrile neutropenia; ≥ Grade 2 peripheral
neuropathy; peritoneal or pleural effusions requiring a tap more frequently than
every 14 days; QT interval corrected (QTc) prolongation or a prior history of serious
arrhythmias or significant abnormalities on screening ECG; previously experienced a
severe reaction to a liposomal product or a taxane; received IV treatment for
bacterial/fungal infection within 7 days of screening.
4. Subject has known significant cardiovascular disease or cerebrovascular accident
within 3 months of enrollment, or within the timeframe as stipulated in the
additional criteria outlined in the protocol.
5. Subject requires the use of the following concomitant treatments/procedures at any
time, per protocol.
6. Subject requires either moderate or strong (if weak, 2 or more) inhibitors or
inducers of Cytochrome P450 3A (CYP3A) mediated metabolism.