Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-S… (NCT03170206) | Clinical Trial Compass
CompletedPhase 1
Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer
United States34 participantsStarted 2017-05-31
Plain-language summary
This trial is being conducted as a possible treatment for lung cancer with a specific change in the KRAS gene.
The drugs involved in this study are:
* Palbociclib
* Binimetinib
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must have histologically confirmed advanced NSCLC (with a confirmed KRAS mutation via any CLIA-certified method) for which curable treatment modalities are not an option
* Part I Dose Escalation: Participants are required to have measurable disease per RECIST 1.1 within 4 weeks of study entry
* MTD Expansion and Part II: Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral CT scan. See section 10 for the evaluation of measureable disease.
* Age ≥ 18 years. Because no dosing or adverse event data are currently available in participants \< 18 years of age, children are excluded from this study
* Participants are permitted to have any number of prior therapies prior to enrollment
* ECOG performance status \< 2 (see Appendix A).
* Participants must have normal organ and marrow function as defined below:
* Absolute neutrophil count \> 1,500mm3
* Hemoglobin \> 9 g/dL
* Platelets \> 100,000/mcL
* Total bilirubin \< 2 X institutional upper limit of normal (ULN)
* AST (SGOT)/ALT (SGPT) \< 2.5 X ULN -OR-
* AST (SGOT)/ALT (SGPT) \< 5.0 X ULN if hepatic metastases are present
* Creatinine \< 1.5 X the institutional ULN -OR-
* Calculated creatinine clearance (determined as per Cockcroft-Gault) \> 50 mL/min
* The effects of palbociclib and binimetinib on the d…
What they're measuring
1
Maximum Tolerated Dose
Timeframe: 2 years
2
Safety and tolerability of Palbocilib and Binimetinib