Clinical trial · Interventional

MK2461 Phase I/II Study in Patients With Advanced Solid Tumors (MK-2461-002 AM1)(COMPLETED)

A Phase I/II Dose Escalation and Proof-of-Concept Study of MK2461 in Patients With Advanced Solid Tumors

NCT00496353CI-TRIAL-00017335completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The purposes of this phase I portion are; 1) to evaluate the safety and tolerability of MK2461 and 2) to determine the recommended phase 2 dose or doses of MK2461. The purpose of the phase II portion is to evaluate the anti-tumor efficacy of MK2461.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Neoplasm	Neoplasm	ONTOLOGY_EXACT	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
MK2461	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

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

Secondary outcomes (1)

measure
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.
timeFrame
18 Months

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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 tumor

References

Publications (0)

Data not yet available

No reference posted for this study.