Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma
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|ClinicalTrials.gov Identifier: NCT03501368|
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : January 20, 2022
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Unresectable Melanoma Advanced Melanoma||Drug: Ceritinib Drug: Trametinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma|
|Actual Study Start Date :||June 27, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: Trametinib + Ceritinib Treatment
Study treatment will be given in cycles. Each cycle will be 4 weeks (28 days). Post-Treatment (follow-up) Period: Participants will return to the study site between 30-40 days after the last dose of trametinib + ceritinib for an end-of-treatment assessment. Additional follow-up will occur for related Adverse Events (AEs) that are not resolved by this time and related Serious Adverse Events (SAEs) that occur after the time of this visit. Participants will be followed for survival every 3 months for the first year following end of treatment, and then every 6 months for up to 5 years after end of treatment.
Participants will take ceritinib by mouth (PO) once daily at a dose of up to 450 mg (3 capsules of 150 mg)
Other Name: ZYKADIA
Participants will take trametinib by mouth at a dose of 2 mg daily
Other Name: MEKINIST
- Maximum Tolerated Dose (MTD) and recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 12 months ]Maximum Tolerated Dose and recommended phase 2 dose of trametinib + ceritinib, determined by number and frequency of treatment related adverse events
- Overall Response Rate (ORR) [ Time Frame: Up to 6 months post treatment ]ORR will be defined by proportion of patients who have achieved a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
- Median Progression-free Survival (PFS) [ Time Frame: Up to 5 years post treatment ]PFS is defined from the time of on-treatment to time of progression, censoring at last clinical follow up or if no longer followed at Moffitt, then based on date of last medical documentation of no progression. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
- Overall Survival (OS) [ Time Frame: Up to 5 years post treatment ]OS is defined as from the time of on-treatment to the time of death, censoring at last date known alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501368
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Deanryan DeAquino 813-745-3998 email@example.com|
|Contact: Zeynep Eroglu, M.D. 813-745-7488 firstname.lastname@example.org|
|Principal Investigator: Zeynep Eroglu, M.D.|
|Principal Investigator:||Zeynep Eroglu, M.D.||H. Lee Moffitt Cancer Center and Research Institute|