A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Skin Cancer, Ovarian Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 3/27/2019 |
Start Date: | April 15, 2016 |
End Date: | November 21, 2018 |
A Phase I Dose Finding Study of Oral LTT462 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations.
A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway
alterations.
alterations.
Inclusion Criteria:
- Patient (male or female) ≥12 years of age
- ECOG (Eastern Cooperative Oncology Group) performance status ≤1
- Must have progressed following standard therapy, or for whom, in the opinion of the
Investigator, no effective standard therapy exists, is tolerated or appropriate.
- Patients must be willing and able to undergo study required biopsies.
- Presence of at least one measurable lesion according to RECIST v1.1.
- Documented MAPK pathway alteration
Exclusion Criteria:
- Prior treatment with ERK inhibitors.
- History or current evidence of retinal vein occlusion (RVO) or current risk factors
for RVO.
- Any medical condition that would, in the investigator's judgment, prevent the
patient's participation in the clinical study due to safety concerns or compliance
with clinical study procedures.
- Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days
prior to the start study treatment and for the duration of the study.
- Patients with malignant disease other than that being treated in the study.
- Clinically significant cardiac disease.
Other protocol-defined exclusion criteria may apply.
We found this trial at
3
sites
Houston, Texas 77030
Principal Investigator: Filip Janku
Phone: 713-792-3238
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230 Park Avenue, 21st Floor
New York, New York 10169
New York, New York 10169
1-888-669-6682)
Principal Investigator: Gopakumar Iyer
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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