A Study of LY2875358 in Participants With Advanced Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
Eli Lilly and Company
Study ID
NCT01287546
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • LY2875358 — DRUG
    Part A Dose escalation of LY2875358 administered intravenously (IV), Day 1 and 15 every 28 days for at least two cycles.
  • LY2875358 + erlotinib — DRUG
    Part A2 Dose escalation of LY2875358 administered IV, on Day 1 and 15 every 28 days for at least two cycles in combination with daily erlotinib dosing (150 mg) taken orally (PO).
  • LY2875358 at Part A highest dose — DRUG
    Part B (Dose Exploration): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles.
  • LY2875358 at Part A highest dose + trametinib — DRUG
    Part B (in combination with trametinib): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles, in combination with trametinib at 2 mg orally once daily

Study Details

The objective of this study is to determine a recommended Phase 2 dose range of LY2875358 that may be safely administered to participants with advanced cancer. In Part A and Part A2 of this study, escalating doses of LY2875358 as monotherapy and in combination with erlotinib will be evaluated for safety and tolerability, respectively. Part B is a dose-confirmation segment for LY2875358 therapy in 5 different types of cancer: nonsquamous non-small cell lung cancer (NSCLC), castrate resistant prostate cancer (CRPC) with bone metastases, renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), or uveal melanoma with liver metastases, and for LY2875358 in combination with trametinib in participants with uveal melanoma with liver metastases.

Key Dates

Start date
Apr 13, 2010
Status verified
Feb 2017
Primary completion
Jan 8, 2015
Completion
Oct 26, 2016

Study Design

Enrollment
117 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LY2875358
  • Experimental: LY2875358 + erlotinib
  • Experimental: LY2875358 at Part A highest dose
  • Experimental: LY2875358 at Part A highest dose + trametinib

Primary Outcome Measure

Recommended Phase 2 dose range of LY2875358 monotherapy and in combination with erlotinib [ Time Frame: Baseline through Cycle 1 ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of California - San DiegoLa JollaCalifornia92037-0845-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-5615-
Univ of California San FranciscoSan FranciscoCalifornia94115-
UCLASanta MonicaCalifornia90404-
Mayo Clinic of JacksonvilleJacksonvilleFlorida32224-
Emory UniversityAtlantaGeorgia30322-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-0946-
Mayo ClinicRochesterMinnesota55902-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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By research site
University of California - San Diego· La Jolla, CACedars Sinai Medical Center· Los Angeles, CAUniv of California San Francisco· San Francisco, CAUCLA· Santa Monica, CAMayo Clinic of Jacksonville· Jacksonville, FLEmory University· Atlanta, GA

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