A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Skin Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:February 24, 2017
End Date:June 29, 2020
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

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A Phase Ib, Open-label, Multicenter Study of Oral LXH254-centric Combinations in Adult Patients With Advanced or Metastatic KRAS or BRAF Mutant Non-Small Cell Lung Cancer or NRAS Mutant Melanoma

To characterize safety and tolerability and identify a recommended dose and regimen for the
LXH254 in combination with LTT462 or trametinib or ribociclib.


Inclusion Criteria:

- Patients must have advanced or metastatic NSCLC or melanoma

- Presence of KRAS or BRAF mutation (NSCLC) or NRAS mutation (melanoma) in tumor tissue

- All patients participating in this clinical trial must have progressed following
standard therapy or, in the opinion of the Investigator, no effective standard therapy
exists, is tolerated, appropriate or is considered equivalent to study treatment.

- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2

Exclusion Criteria:

- Dose expansion - KRAS or NRAS mutant patients groups: Prior treatment with a RAFi
(including any BRAFi and pan-RAFi), MEKi and/or ERKi. BRAF mutant patients group:
Prior treatment with an ERKi and/or a pan-RAFi.

- 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 Gilbert's syndrome or other heritable diseases of bile processing.

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
2
sites
Boston, Massachusetts 02118
Principal Investigator: Rebecca Heist
Phone: 617-726-1849
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Melbourne, Victoria
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