SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT02014909

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Part I and Part II A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KTN3379 in Adult Subjects With Advanced Tumors Alone or With Chemotherapy

Part I will evaluate the pharmacokinetic profile and safety of KTN3379 over several doses with the objective of defining a Phase 2 dose in patients with advanced malignancies. Part II will evaluate the pharmacokinetic profile and safety of KTN3379 in combination with other targeted agents and obtain preliminary evidence of anti tumor activity in specific types of cancer. Patients will continue receiving KTN3379 alone or in combination until disease progression or toxicity that necessitates discontinuation (whichever comes first).

NCT02014909 Advanced Cancer

1 Interventions

Name: KTN3379

Description: Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease
Type: Biological
Group Labels: 5

KTN3379 Part II, Arm A Part II, Arm B Part II, Arm C Part II, Arm D


Primary Outcomes

Description: Continued assessment of safety

Measure: Dose limiting toxicities for KTN3379 alone or in combination

Time: Participants will be followed for the duration of treatment, an expected average of 3 cycles/9 weeks

Secondary Outcomes

Measure: Area Under the Concentration-Time Curve (AUC 0 through end of study)

Time: Prior to the initial dose on day 1 through duration of treatment, an expected average of 3 cycles/9 weeks

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 V600E

Part II Arm A have head and neck cancer or K-Ras wild type EGFR expressing colon cancer, Arm B, have non small cell lung cancer, Arm C, have BRAF V600E mutated melanoma and Arm D have HER2 positive breast or gastric cancer that has progressed following one or more treatments for advanced or metastatic disease. --- V600E ---



HPO Nodes