Phase I Trial of Afatinib (BIBW 2992) and Dasatinib in Non-small Cell Lung Cancer (NSCLC)
|ClinicalTrials.gov Identifier: NCT01999985|
Recruitment Status : Active, not recruiting
First Posted : December 3, 2013
Last Update Posted : January 11, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Non-small Cell Lung Cancer (NSCLC)||Drug: Dasatinib - 1A Drug: Afatinib - 1A Drug: Dasatinib - 1B Drug: Afatinib - 1B||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||December 31, 2013|
|Primary Completion Date :||March 21, 2017|
|Estimated Study Completion Date :||March 2019|
Experimental: 1A - Dose Escalation Group
Dose escalation: Afatinib and Dasatinib. This study is divided into two parts. The first 8 - 18 people will be entered in the first part, called Phase 1A. Then this part will end.
Drug: Dasatinib - 1A
1A: Begins Day 8. Level 1 - 100 mg, Level 2 - 100 mg, Level 3 - 140 mg.
Other Names:Drug: Afatinib - 1A
1A: Begins Day 1. Level 1 - 30 mg, Level 2 - 40 mg, Level 3 - 40 mg.
Experimental: 1B - Extension Group
Extension: Afatinib and Dasatinib. The next 20 people will enter into the second part, called Phase 1B.
Drug: Dasatinib - 1B
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.Drug: Afatinib - 1B
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.
- Maximum Tolerated Dose (MTD) of BIBW 2992 in Combination with Dasatinib [ Time Frame: Up to 6 Months ]
1A - 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).
- Objective Response Rate [ Time Frame: Up to 6 Months ]Estimate the objective response rate (complete response [CR] and partial response [PR]), and clinical benefit rate, in participants with acquired EGFR resistance. Response Criteria for Phase 1B will follow RECIST v.1.1: Complete Response (CR is defined as disappearance of all target lesions; Partial Response (PR) is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD.
- Progression Free Survival Rate [ Time Frame: Up to 6 Months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999985
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Ben Creelan, M.D.||H. Lee Moffitt Cancer Center and Research Institute|