Titre A Phase 1b/2a Two-Part Open-Label Multicenter Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer
Protocole ID ESPS-001
ClinicalTrials.gov ID NCT02632448
Type(s) de cancer Tumeurs solides
Phase Phase I-II
Stade Maladie avancée ou métastatique
Type étude Traitement
Médicament LY2880070 seul ou avec gemcitabine
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL  
Ville Montréal
Investigateur(trice) principal(e) Dre Diane Provencher
Coordonnateur(trice) Marie Martin
514-890-8000 poste 30737
Statut Actif en recrutement
Date d'activation 07-12-2018
Critètes d'éligibilité
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have an estimated life expectancy of greater than or equal to (≥)12 weeks
  • Have adequate organ function
  • Have received 1-4 prior standard anti-cancer therapies
  • Agree to use medically approved contraceptives during the study and for 3 months following the last study treatment
  • Females with child-bearing potential must have a negative serum pregnancy test result, and a negative urine pregnancy test result, prior to the first study treatment
  • Have tumor lesions considered measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • For Part A
  • Must have evidence of cancer (solid tumors, excluding glioblastoma and primary brain tumor) that is advanced or metastatic
  • For the Metabolism Phenotype Arm in Part A, participants must have a Cytochrome P450 (CYP2D6) poor metabolizer phenotype
  • For Part B
  • Have advanced or metastatic colorectal cancer, triple negative breast cancer, or ovarian cancer
  • Participants with ovarian cancer must be eligible to receive Gemcitabine (GEM) and not refractory to GEM/carboplatin
Critètes d'exclusion
  • Have received treatment with an investigational drug which has not received regulatory approval within 21 days of first study treatment
  • Have symptomatic central nervous system (CNS) metastasis
  • Females who are pregnant or nursing
  • Have known positive test results of human immunodeficiency virus, or have chronic active hepatitis A, B or C
  • Have a corrected QT interval (QTcB) greater than (>) 470 milliseconds (msec) (female) or >450 msec (male), or a history of congenital long QT syndrome
  • Have had a bone marrow transplant
  • Have participated in this study, or are currently enrolled in another clinical study of an investigational medicinal product
  • Have had radiation therapy to >25% of bone marrow
  • For Part B
  • Have a history of another active cancer within the past year, except cervical cancer in situ, in situ carcinoma of the bladder, basal cell carcinoma of the skin, or another in situ carcinoma that is considered cured