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MK2461

Phase 1

Advanced Cancer | Small molecule | Oncology |Merck & Company, Inc.|Trials Updated: Mar 31, 2015

MK2461 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jul 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment51

FDA Designations

No designations recorded

MK2461 clinical trials

MK2461 · 2 trials · 2 indications

Phase 1 2
NCT00496353MK2461 Phase I/II Study in Patients With Advanced Solid Tumors (MK-2461-002 AM1)(COMPLETED)Neoplasm
COMPLETED26 Analytics
NCT00518739MK2461 in Patients With Advanced Cancer (2461-001)(COMPLETED)Advanced Cancer
COMPLETED25 Analytics
PHASE1COMPLETED
MK2461 Phase I/II Study in Patients With Advanced Solid Tumors (MK-2461-002 AM1)(COMPLETED)
NeoplasmUnlock trial analytics
PHASE1COMPLETED
MK2461 in Patients With Advanced Cancer (2461-001)(COMPLETED)
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated.
18 Months
To evaluate the safety and tolerability of MK2461
18 Months

Secondary Endpoints

To evaluate the anti-tumor efficacy of MK2461 in patients with advanced solid tumor by assessing the response rate, progression- free survival, duration of response, time to response and time to progression.
18 Months
To determine the Recommend Phase II Dose or doses (RP2D) based on safety, tumor pharmacodynamics, and parmacokinetics.
18 Months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
MK2461DRUGMK2461 treatment, bid, 28-day
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients must be at least 18 years of age, with adequate organ function, and an ecog performance of \<2 Exclusion Criteria: * No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation * Patients must not have primary central nervous system tumo...

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Competitive Landscape -Cancer 7 trials (matched to "Advanced Cancer")

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Frequently asked questions about MK2461

What is MK2461 used for?

MK2461 is an investigational small molecule being developed for oncology indications, specifically for the treatment of advanced solid tumors and advanced cancer. It was studied in patients with neoplasms and advanced cancer in early-phase clinical trials. The drug is not approved and remains in clinical development.

Who makes MK2461?

MK2461 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company sponsored early-phase clinical trials of the drug in patients with advanced solid tumors and advanced cancer.

What phase is MK2461 in?

MK2461 is in Phase 1 clinical development. Two Phase 1 trials of the drug have been completed, one in patients with advanced solid tumors and one in patients with advanced cancer. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is MK2461 in?

MK2461 has been studied in two completed Phase 1 clinical trials: NCT00496353, a Phase I/II study in patients with advanced solid tumors, and NCT00518739, a study in patients with advanced cancer. Both trials were uncontrolled and non-randomized, with a combined enrollment of 51 patients.

Is MK2461 the same as MK-2461?

Yes, MK2461 and MK-2461 refer to the same investigational drug. Clinical trial records use both naming conventions, with the hyphenated form appearing in study titles such as 'MK-2461-002 AM1' and '2461-001'. Both names denote the same small molecule oncology candidate.