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

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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.


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
230 Park Avenue, 21st Floor
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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Houston, Texas 77030
Principal Investigator: Filip Janku
Phone: 713-792-3238
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Houston, TX
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