Trial to Study the Safety of Intravenous MNK-010 in Advanced Solid Tumors
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-Label, Phase 1 First in Human Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous MNK-010 in Subjects With Advanced Solid Tumors|
- Maximum tolerated dose (MTD) [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]MTD of MNK-010
- Treatment-emergent adverse events (TEAEs) [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) of at least Grade 3 severity, and discontinuations due to AEs. AEs will be evaluated and categorized in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
- Clinical labs [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]Changes from baseline in clinical laboratory assessments, vital signs, arterial oxygen saturation (SaO2) by pulse oximetry, physical examination, and 12-lead electrocardiograms (ECGs)
- Plasma PK [ Time Frame: 27 months ] [ Designated as safety issue: No ]Standard plasma PK parameters will be measured following single and multiple doses.
- Overall response [ Time Frame: 27 months ] [ Designated as safety issue: No ]Best confirmed overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
|Study Start Date:||July 2013|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Subjects will receive 1 dose of MNK-010 followed by a 7-day post dose assessment period per treatment cycle. Dose levels will be based upon the amount of active delivered per square meter of body surface area (mg/m2). Cycles will repeat every 3 weeks (21 days) based on toxicity and response, as determined by a Safety Review Committee (SRC). Subjects will continue treatment with MNK-010 until unacceptable toxicity, documented progression of disease, another criterion for discontinuation is met, or until 4 treatment cycles have been completed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02040558
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Ashley Ferguson 617-582-7501 firstname.lastname@example.org|
|Principal Investigator: Geoffrey Ira Shapiro, MD|