Trial of Trametinib and Ponatinib in Patients With KRAS Mutant Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03704688
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the safety of the combination of ponatinib and trametinib as well as the most appropriate dosages of the combination.

Key Dates

Start date
Oct 9, 2018
Status verified
Feb 2022
Primary completion
Feb 4, 2022
Completion
Feb 4, 2022

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Dose Level -3
    Trametinib 0.5mg PO q daily Ponatinib 15mg PO q daily
  • Experimental: Phase I: Dose Level -2
    Trametinib 1.0 mg PO q daily Ponatinib 15mg PO q daily
  • Experimental: Phase I: Dose Level -1
    Trametinib 1.5 mg PO q daily 15mg PO q daily
  • Experimental: Phase I: Dose Level 1
    Trametinib 2 mg PO q daily Ponatinib 15mg PO q daily
  • Experimental: Phase I: Dose Level 2
    Trametinib 2 mg PO q daily Ponatinib 30mg PO q daily
  • Experimental: Phase II
    Maximum tolerated dose as established in Phase I portion

Primary Outcome Measure

Maximum Tolerated Dose of Ponatinib, Phase I [ Time Frame: maximum of 18 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity)CommackNew York11725-
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604-
Memorial Sloan - Kettering Cancer CenterNew YorkNew York10021-
Memorial Sloan Kettering Nassau (Limited protocol activity)UniondaleNew York11553-

Find similar trials in Basking Ridge, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan - Kettering Cancer Center· New York, NY

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