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Wnt Inhibitor
LGK974 for Cancer
Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with specified cutaneous melanoma conditions are eligible for LGK974 with PDR001 dose expansion
Patients with specified cancers previously treated with anti-PD-1 therapy and whose best response was progressive disease are eligible for LGK974 with PDR001 dose escalation
Must not have
Malignant disease other than that being treated in this study
Osteoporosis, osteopenia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 61 months
Awards & highlights
Summary
This trial is testing a new drug called LGK974 to see if it is safe and effective in treating adults with cancer that has progressed despite standard therapy or for which no effective standard therapy exists.
Who is the study for?
Adults with advanced cancers like melanoma, cervical, esophageal, colorectal, and breast cancer that have worsened despite treatment or lack a standard therapy. Eligible participants include those with certain genetic mutations or who've had specific prior treatments. People with heart issues, bone diseases, other active cancers, untreated brain metastases, severe autoimmune conditions or allergies to monoclonal antibodies can't join.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dosing of LGK974 alone and combined with PDR001 in patients. It aims to determine how well these drugs can be tolerated by individuals whose cancers are reliant on Wnt ligands for growth and who have exhausted other treatment options.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs; gastrointestinal disturbances which could affect drug absorption; bone-related issues; and possibly increased susceptibility to infections due to immune response alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a specific type of skin cancer eligible for a certain treatment.
Select...
My cancer worsened after anti-PD-1 therapy, so I can try LGK974 with PDR001.
Select...
My advanced cancer has worsened despite treatment, or there's no effective treatment for it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any cancer other than the one being treated in this study.
Select...
I have been diagnosed with osteoporosis or osteopenia.
Select...
I have had a recent bone fracture or a fracture caused by disease.
Select...
My heart does not function properly.
Select...
I have brain metastases that have not been treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 61 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~61 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose or Recommended Dose for Expansion of LGK974 as a single agent or in combination with PDR001 in patients treated
Secondary outcome measures
Absorportion and plasma concentrations of PDR001
Absorption and plasma concentrations of LGK974
Overall response rate of tumor
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: LGK974 in combination with PDR001Experimental Treatment2 Interventions
LGK in combination with PDR001
Group II: LGK974Experimental Treatment1 Intervention
LGK974
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PDR001
2016
Completed Phase 2
~2700
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,874 Previous Clinical Trials
4,199,806 Total Patients Enrolled
88 Trials studying Breast Cancer
37,818 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a specific type of skin cancer eligible for a certain treatment.I do not have any cancer other than the one being treated in this study.I have been diagnosed with osteoporosis or osteopenia.I have had a recent bone fracture or a fracture caused by disease.My heart does not function properly.I have a stomach or intestine problem that affects how my body absorbs medicine.I have brain metastases that have not been treated.My cancer worsened after anti-PD-1 therapy, so I can try LGK974 with PDR001.You have an ongoing autoimmune disease or severe allergic reactions to other monoclonal antibodies.You have certain abnormal test results as outlined in the study plan.My advanced cancer has worsened despite treatment, or there's no effective treatment for it.My cancer has specific genetic changes approved by Novartis.My cancer is B-RAF mutant colorectal or pancreatic.
Research Study Groups:
This trial has the following groups:- Group 1: LGK974
- Group 2: LGK974 in combination with PDR001
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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