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Report for Clinical Trial NCT01999985

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase I Trial Evaluating Safety and Tolerability of the Irreversible Epidermal Growth Factor Receptor Inhibitor Afatinib (BIBW 2992) in Combination With the SRC Kinase Inhibitor Dasatinib for Patients With Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to: - Find out if the study drugs Afatinib and Dasatinib can be safely given together to patients with lung cancer - Learn how these two drugs work in cancer cells when they are combined - Learn more about the side effects of these two drugs when combined - Find the highest doses of the study drugs Afatinib and Dasatinib that can be given safely without causing serious side effects

NCT01999985 Lung Cancer Non-small Cell Lung Cancer (NSCLC)
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

4 Interventions

Name: Dasatinib - 1A

Description: 1A: Begins Day 8. Level 1 - 100 mg, Level 2 - 100 mg, Level 3 - 140 mg.
Type: Drug
Group Labels: 1

Dose Escalation and Dose Expansion

Name: Afatinib - 1A

Description: 1A: Begins Day 1. Level 1 - 30 mg, Level 2 - 40 mg, Level 3 - 40 mg.
Type: Drug
Group Labels: 1

Dose Escalation and Dose Expansion

Name: Dasatinib - 1B

Description: In Phase 1B, a mutationally selected 20 participants (total) will be treated at the recommended dose to confirm tolerability and evaluate for early response signal.
Type: Drug
Group Labels: 1

Dose Escalation and Dose Expansion

Name: Afatinib - 1B

Description: In Phase 1B, a mutationally selected 20 participants (total) will be treated at the recommended dose to confirm tolerability and evaluate for early response signal.
Type: Drug
Group Labels: 1

Dose Escalation and Dose Expansion


Primary Outcomes

Description: The MTD for this combined treatment will be defined as either: The highest dosage cohort in which six patients had been treated and there were less than two dose limiting toxicities (DLTs) or, Afatinib at the highest tolerated dose investigated (40 mg by mouth [PO] daily) plus dasatinib at the highest tolerated dose investigated (cohort 3, 140 mg PO daily).

Measure: Maximum Tolerated Dose (MTD) of Afatinib (BIBW 2992) in Combination With Dasatinib

Time: Up to 6 Months

Secondary Outcomes

Description: Estimates objective response rate (complete response [CR] and partial response [PR]) in participants with acquired EGFR resistance

Measure: Number of Participants With Objective Response

Time: Up to 6 Months

Description: Estimate the 6-month progression free survival (PFS) rate in participants with acquired EGFR resistance. Response Criteria for Phase 1B will follow RECIST v.1.1: Progressive Disease (PD) is defined as at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Measure: Median Progression Free Survival

Time: Up to 6 Months

Purpose: Treatment

Sequential Assignment


There is one SNP

SNPs


1 T790M

- Either or both of the following: Progression or recurrence of disease after receiving prior continuous gefitinib, afatinib, or erlotinib; A tumor known to harbor a de novo T790M mutation, which is known to confer EGFR TKI resistance. --- T790M ---



HPO Nodes


HPO: