Phase I Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer (NSCLC)
Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: erlotinib hydrochloride
Drug: dovitinib lactate
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer|
- Measure toxicity to determine the MTD of the combination of erlotinib hydrochloride and dovitinib lactate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Dose limiting toxicity (DLT) is defined as a CTCAE v4.0 toxicity >= grade 3 or 4 occurring after 3 weeks of treatment. If 2 of 6 patients experience a DLT, then the MTD will be defined as the dose tolerated by the cohort preceding the cohort experiencing the DLT.
- ORR (complete response [CR]+ partial response [PR]) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- PFS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- OS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2015|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive erlotinib hydrochloride PO QD. Starting on day 15, patients also receive dovitinib lactate PO QD on days 1-5 of each week. Treatment continues in the absence of disease progression or unacceptable toxicity.
Drug: erlotinib hydrochloride
Other Names:Drug: dovitinib lactate
I. To characterize the safety and tolerability of the combination of erlotinib (erlotinib hydrochloride) and dovitinib (dovitinib lactate), assessing for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
II. To determine the maximum tolerated dose (MTD) of the combination of erlotinib and dovitinib.
I. To evaluate overall response rate (ORR), progression free survival (PFS), and overall survival (OS) of patients receiving the combination of erlotinib and dovitinib, although this phase will allow for patients who received any number of prior treatments, including prior treatment with erlotinib.
II. To evaluate the potential impact of dovitinib on erlotinib pharmacokinetics (PK).
OUTLINE: This is a dose-escalation study.
Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Starting on day 15, patients also receive dovitinib lactate PO QD on days 1-5 of each week. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515969
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Heather Wakelee||Stanford University|