Intermittent Selumetinib for Uveal Melanoma

Part of paid clinical trials in New York, New York.

Sponsor
Shaheer A. Khan
Study ID
NCT02768766
Phase
PHASE1
Status
Completed

Conditions

  • Uveal Melanoma

Eligibility Criteria

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

Interventions

  • Selumetinib, 100mg — DRUG
    100mg, oral capsules, twice daily An orally active, small molecule with potential antineoplastic activity. Selumetinib is an ATP-independent inhibitor of mitogen-activated protein kinase kinase (MEK) or MAPK/extracellular-signal-regulated kinase (ERK) kinase) 1 and 2. Inhibition of both MEK1 and 2 by selumetinib prevents the activation of MEK1/2 dependent effector proteins and transcription factors, thereby leading to an inhibition of cellular proliferation in various cancers.
  • Selumetinib, 125mg — DRUG
    125mg, oral capsules, twice daily An orally active, small molecule with potential antineoplastic activity. Selumetinib is an ATP-independent inhibitor of mitogen-activated protein kinase kinase (MEK) or MAPK/extracellular-signal-regulated kinase (ERK) kinase) 1 and 2. Inhibition of both MEK1 and 2 by selumetinib prevents the activation of MEK1/2 dependent effector proteins and transcription factors, thereby leading to an inhibition of cellular proliferation in various cancers.
  • Selumetinib, 150mg — DRUG
    150mg, oral capsules, twice daily An orally active, small molecule with potential antineoplastic activity. Selumetinib is an ATP-independent inhibitor of mitogen-activated protein kinase kinase (MEK) or MAPK/extracellular-signal-regulated kinase (ERK) kinase) 1 and 2. Inhibition of both MEK1 and 2 by selumetinib prevents the activation of MEK1/2 dependent effector proteins and transcription factors, thereby leading to an inhibition of cellular proliferation in various cancers.
  • Selumetinib, 175mg — DRUG
    175mg, oral capsules, twice daily An orally active, small molecule with potential antineoplastic activity. Selumetinib is an ATP-independent inhibitor of mitogen-activated protein kinase kinase (MEK) or MAPK/extracellular-signal-regulated kinase (ERK) kinase) 1 and 2. Inhibition of both MEK1 and 2 by selumetinib prevents the activation of MEK1/2 dependent effector proteins and transcription factors, thereby leading to an inhibition of cellular proliferation in various cancers.
  • Selumetinib, 200mg — DRUG
    200mg, oral capsules, twice daily An orally active, small molecule with potential antineoplastic activity. Selumetinib is an ATP-independent inhibitor of mitogen-activated protein kinase kinase (MEK) or MAPK/extracellular-signal-regulated kinase (ERK) kinase) 1 and 2. Inhibition of both MEK1 and 2 by selumetinib prevents the activation of MEK1/2 dependent effector proteins and transcription factors, thereby leading to an inhibition of cellular proliferation in various cancers.
  • Selumetinib, 225mg — DRUG
    225mg, oral capsules, twice daily An orally active, small molecule with potential antineoplastic activity. Selumetinib is an ATP-independent inhibitor of mitogen-activated protein kinase kinase (MEK) or MAPK/extracellular-signal-regulated kinase (ERK) kinase) 1 and 2. Inhibition of both MEK1 and 2 by selumetinib prevents the activation of MEK1/2 dependent effector proteins and transcription factors, thereby leading to an inhibition of cellular proliferation in various cancers.

Study Details

The purpose of this study is to find out what effects, good and/or bad, intermittent dosing of the drug Selumetinib will have on subjects with uveal melanoma. Selumetinib is a drug that blocks (or turns off) methyl ethyl ketone (MEK), a protein activated in some uveal melanoma cells. Selumetinib is a MEK inhibitor. Blocking MEK may stop the cancer from growing.

Key Dates

Start date
Feb 28, 2017
Status verified
Aug 2023
Primary completion
Sep 18, 2020
Completion
Sep 18, 2020

Study Design

Enrollment
42 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1: Selumetinib
    Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 100mg.
  • Experimental: Dose Level 2: Selumetinib
    Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 125mg.
  • Experimental: Dose Level 3: Selumetinib
    Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 150mg.
  • Experimental: Dose Level 4: Selumetinib
    Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 175mg.
  • Experimental: Dose Level 5: Selumetinib
    Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 200mg.
  • Experimental: Dose Level 6: Selumetinib
    Subjects will receive selumetinib (hyd-sulfate AZD6244) orally twice a day for three days followed by four days off in four week cycles at a dose of 225mg.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of intermittent selumetinib [ Time Frame: Up to 8 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in New York, NY

By research site
Columbia University Medical Center· New York, NYMemorial Sloan Kettering Cancer Center· New York, NYMD Anderson Cancer Center· Houston, TX

Related Studies