Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT04521686
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Any Solid Tumor
  • Cholangiocarcinoma
  • Chondrosarcoma
  • Glioma

Eligibility Criteria

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

Interventions

  • LY3410738 — DRUG
    Oral LY3410738
  • Gemcitabine — DRUG
    Intravenous gemcitabine
  • Cisplatin — DRUG
    Intravenous cisplatin
  • Durvalumab — DRUG
    Intravenous durvalumab

Study Details

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangiocarcinoma.

Key Dates

Start date
Oct 1, 2020
Status verified
Apr 2026
Primary completion
Jul 17, 2023
Completion
May 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LY3410738
    Phase 1 dose escalation - Multiple doses of LY3410738
  • Experimental: LY3410738 alone or in combination with gemcitabine and cisplatin or in combination with durvalumab
    Phase 1 dose expansion - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of LY3410738 alone or in combination with gemcitabine plus cisplatin or in combination with durvalumab

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 24 months ]

Locations (17)

FacilityCityStateZIPSite coordinators
Mayo Clinic of ScottsdalePhoenixArizona85054-
The University of Arizona Cancer CenterTucsonArizona85724-
USC Norris Cancer HospitalLos AngelesCalifornia90033-
Mayo Clinic in FloridaJacksonvilleFlorida32224-
University of Chicago Pritzker School of MedicineChicagoIllinois60637-
Indiana University School of MedicineIndianapolisIndiana46202-
The John Hopkins HospitalBaltimoreMaryland21287-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo ClinicRochesterMinnesota55902-
Memorial Sloan Kettering Cancer CenterMiddletownNew Jersey07748-
Memorial Sloan Kettering Cancer CenterCommackNew York11725-
Memorial Sloan Kettering Cancer CenterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Sarah Cannon Cancer CenterNashvilleTennessee37203-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics, LLCSan AntonioTexas78229-

Find similar trials in Phoenix, AZ

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By specialty
OncologyNeuro-oncology
By research site
Mayo Clinic of Scottsdale· Phoenix, AZThe University of Arizona Cancer Center· Tucson, AZUSC Norris Cancer Hospital· Los Angeles, CAMayo Clinic in Florida· Jacksonville, FLUniversity of Chicago Pritzker School of Medicine· Chicago, ILIndiana University School of Medicine· Indianapolis, IN

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