Study of MK-8353 + Selumetinib in Advanced/Metastatic Solid Tumors (MK-8353-014)

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03745989
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-8353 — DRUG
    Participants will receive MK-8353 orally twice daily (BID), escalated sequentially from 50 mg to 250 mg.
  • Selumetinib — DRUG
    Participants will receive selumetinib orally BID, escalated sequentially from 25 mg to 75 mg.

Study Details

This is a multicenter, worldwide, open-label study of MK-8353 in combination with selumetinib in participants with histologically or cytologically confirmed diagnosis of advanced solid tumor. This study will evaluate the safety, tolerability, and exploratory efficacy of MK-8353 in combination with selumetinib.

Key Dates

Start date
Feb 22, 2019
Status verified
Jul 2023
Primary completion
Mar 19, 2021
Completion
Mar 19, 2021

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MK-8353 and Selumetinib Dose Escalation
    Participants will receive a combination MK-8353 and selumetinib for 4 days on and 3 days off until disease progression or discontinuation. MK-8353 will be escalated sequentially from 50 mg to 250 mg based on pharmacokinetic and safety data. Selumetinib will be escalated sequentially from 25 mg to 75 mg based on pharmacokinetic and safety data. Doses may be adjusted downward sequentially based on tolerability

Primary Outcome Measure

Number of Participants Experiencing Dose Limiting Toxicities [ Time Frame: Cycle 1 (3-week Cycle) (Up to 3 weeks) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Florida Cancer Specialists ( Site 7000)SarasotaFlorida34232-
Next Oncology ( Site 0001)San AntonioTexas78229-

Find similar trials in Sarasota, FL

By research site
Florida Cancer Specialists· Sarasota, FLNext Oncology· San Antonio, TX

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