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Kinase Inhibitor

LEE011 for Melanoma (LOGIC-2 Trial)

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up c1 (1.5, 4 hrs post-dose on d1; pre-dose on d8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on d15; 24 hrs post-dose on d16; pre-dose on d21); c2 (pre-dose on d1 and d15); c3 pre-dose on d1; c4 pre-dose on d1; c5 pre-dose on d1; eot
Awards & highlights

LOGIC-2 Trial Summary

This trial is testing the effectiveness of LGX818/MEK162 in combination with other targeted agents to treat cancer after progression on LGX818/MEK162 combination therapy.

LOGIC-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~c1 (1.5, 4 hrs post-dose on d1; pre-dose on d8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on d15; 24 hrs post-dose on d16; pre-dose on d21); c2 (pre-dose on d1 and d15); c3 pre-dose on d1; c4 pre-dose on d1; c5 pre-dose on d1; eot
This trial's timeline: 3 weeks for screening, Varies for treatment, and c1 (1.5, 4 hrs post-dose on d1; pre-dose on d8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on d15; 24 hrs post-dose on d16; pre-dose on d21); c2 (pre-dose on d1 and d15); c3 pre-dose on d1; c4 pre-dose on d1; c5 pre-dose on d1; eot for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR): Part II
Secondary outcome measures
Actual Dose Intensity: Part I
Actual Dose Intensity: Part II
Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II
+40 more

LOGIC-2 Trial Design

5Treatment groups
Experimental Treatment
Group I: LGX818 + MEK162 + LEE011Experimental Treatment1 Intervention
Group II: LGX818 + MEK162 + INC280Experimental Treatment1 Intervention
Group III: LGX818 + MEK162 + BKM120Experimental Treatment1 Intervention
Group IV: LGX818 + MEK162 + BGJ398Experimental Treatment1 Intervention
Group V: LGX818 + MEK162Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Encorafenib
FDA approved
Ribociclib
FDA approved
Infigratinib
FDA approved
Buparlisib
Not yet FDA approved
Capmatinib
FDA approved
Binimetinib
FDA approved

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,716 Total Patients Enrolled
51 Trials studying Melanoma
49,296 Patients Enrolled for Melanoma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,884 Total Patients Enrolled
25 Trials studying Melanoma
3,270 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total cohort size of this investigation?

"Unfortunately, this research protocol has already stopped recruiting participants. It was initially posted on July 23rd 2014 and last updated December 4th 2022. Nevertheless, there are currently 757 clinical trials searching for melanoma patients and 134 active studies enrolling people taking LEE011."

Answered by AI

What other trials have been conducted that incorporate the drug LEE011?

"LEE011 was initially researched in 2011 by St. Luke's University Health Network, and subsequently there have been 131 successful trials conducted. The medication is currently being tested at 134 clinical sites around the world, with a significant proportion of these tests taking place within Toronto, Ontario."

Answered by AI

What potential risks does LEE011 pose to human health?

"We rate LEE011's safety a 2, as this is phase two and there are data points affirming its security but no clinical trial results proving efficacy."

Answered by AI

What medical condition is LEE011 typically indicated for?

"LEE011 has proven to be a beneficial therapeutic for malignant neoplasms, as well as unresectable melanoma, postmenopause, and human Fgfr2 protein."

Answered by AI

In what areas is the oversight of this clinical trial occurring?

"Patients are being accepted from Princess Margaret Cancer Center in Toronto, Sir Mortimer B. Davis-Jewish General Hospital in Montreal, and OHSU Knight Cancer Institute in Portland, as well as other 20 sites across North America."

Answered by AI

Is the enrollment period still active for this research endeavor?

"This research is no longer seeking potential subjects. Initially posted on July 23rd 2014, and most recently updated on December 4th 2022, it has since been concluded. However, if you are exploring alternatives then 757 studies associated with melanoma and 134 trials using LEE011 are presently recruiting participants."

Answered by AI

Has this experiment ever been attempted before?

"Since 2011, the drug LEE011 has been studied extensively. Initially sponsored by Pfizer, this medication was first trialled in 2011 and after a successful 183-person study it received Phase 2 approval. Currently, there are 134 active studies concerning LEE011 taking place across 54 nations within 1608 cities worldwide."

Answered by AI
~15 spots leftby Apr 2025