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Also known as SPRYCEL®, BMS-354825, tyrosine kinase inhibitor, SRC Kinase Inhibitor
Dasatinib- 1A · 1 trial · 2 indications
The MTD for this combined treatment will be defined as either: 1. The highest dosage cohort in which six patients had been treated and there were less than two dose limiting toxicities (DLTs) or, 2. 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).
| Arm | Type | Description |
|---|---|---|
| Dose Escalation and Dose Expansion | EXPERIMENTAL | Dose escalation followed by dose expansion. Escalation cohort: 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. Expansion cohort:: Afatinib and Dasatinib. The next 20 people will enter into the second part, called Phase 1B. |
| Name | Type | Description |
|---|---|---|
| Dasatinib - 1A | DRUG | 1A: Begins Day 8. Level 1 - 100 mg, Level 2 - 100 mg, Level 3 - 140 mg. |
| Afatinib - 1A | DRUG | 1A: Begins Day 1. Level 1 - 30 mg, Level 2 - 40 mg, Level 3 - 40 mg. |
| Dasatinib - 1B | DRUG | 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. |
| Afatinib - 1B | DRUG | 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. |
Inclusion Criteria: * Pathologically or cytologically documented Stage IIIB/IV non-small cell lung cancer, or unresectable recurrent disease following locoregional treatment. * For Phase 1B Extension Only: * Either or both of the following: A tumor which harbors an activating Epidermal Growth Fa...
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Dasatinib- 1A is an investigational small molecule studied in lung cancer, specifically non-small cell lung cancer (NSCLC). It was evaluated in a Phase 1 trial in combination with afatinib (BIBW 2992) in adults 18 years and older. The trial has been completed.
Dasatinib- 1A is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company sponsored the Phase 1 study of the agent in non-small cell lung cancer.
Dasatinib- 1A is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are listed. The agent is investigational and is not described as FDA approved for any indication.
Dasatinib- 1A was studied in trial NCT01999985, a Phase 1 trial of afatinib (BIBW 2992) and dasatinib in non-small cell lung cancer. The trial enrolled 25 participants in the United States, was uncontrolled, and has been completed.
Yes. Dasatinib- 1A and Dasatinib - 1A refer to the same investigational agent, differing only in spacing and punctuation. Both names point to the Bristol-Myers Squibb small molecule studied in the Phase 1 non-small cell lung cancer trial NCT01999985.
No. The Phase 1 trial of Dasatinib- 1A, NCT01999985, was an uncontrolled study that was neither randomized nor double blind. It enrolled 25 participants with lung cancer, including non-small cell lung cancer, and the study has been completed.