A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

Last updated: March 27, 2024
Sponsor: Esperas Pharma Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Sarcoma

Pancreatic Cancer

Treatment

LY2880070

Gemcitabine

Clinical Study ID

NCT02632448
ESPS-001
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this 3-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 systemic therapies for locally advanced or metastatic disease
  • Agree to use medically approved contraceptives during the study and for 3 monthsfollowing the last study treatment
  • All females must have a negative serum pregnancy test result, and females ofchild-bearing potential must have a negative urine pregnancy test result, prior to thefirst study treatment
  • Have tumor lesions considered measurable by the Response Evaluation Criteria in SolidTumors (RECIST) v1.1
  • Must be, in the judgment of the investigator, an appropriate candidate forexperimental therapy, and no standard therapy would confer clinical benefit For Part A
  • Must have evidence of cancer (solid tumors, excluding glioblastoma and primary braintumor) 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 (perAmerican Society of Clinical Oncology-College of American Pathology guidelines),epithelial ovarian cancer, endometrial, soft tissue sarcoma, pancreatic cancer
  • For TNBC:
  • Recurrent/refractory Triple Negative Breast Cancer (TNBC) defined as anybeast cancer that expresses <1% estrogen receptor (ER) and <1% progesteronereceptor (PR) and is Her2 negative
  • For Colorectal (CRC):
  • Must have histologically confirmed advanced or metastatic colorectal cancer
  • For Ovarian Cancer:
  • Must have histologically confirmed advanced or metastatic epithelial ovariancancer
  • Must be eligible to receive Gemzar (GEM) and not refractory toGEM/carboplatin
  • Must have the ability to tolerate GEM
  • May have received GEM as previous therapy
  • For Endometrial cancer:
  • Must have histologically confirmed endometrial cancer that is metastatic orlocally advanced
  • Must have failed at least 1 prior chemotherapy
  • For STS:
  • Must have histologically confirmed STS that is metastatic or locallyadvanced
  • Patients with gastrointestinal stromal tumors (GIST) must have failed a KITinhibitor
  • Must have failed at least 1 prior chemotherapy
  • For Pancreatic Cancer:
  • Must have histologically confirmed pancreatic cancer that is metastatic orlocally advanced
  • Must have failed at least 1 prior chemotherapy regimen
  • For Part C
  • Participants with high grade serous ovarian cancer (HGSOC) will be screened forspecific genetic signatures

Exclusion

Exclusion Criteria:

  • Have received treatment with an investigational drug which has not received regulatoryapproval 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 chronicactive 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 studyof 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 cervicalcancer in situ, in situ carcinoma of the bladder, basal cell carcinoma of theskin, or another in situ carcinoma that is considered cured

Study Design

Total Participants: 229
Treatment Group(s): 2
Primary Treatment: LY2880070
Phase: 1/2
Study Start date:
May 16, 2016
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N 4N2
    Canada

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • BC Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • Juravinski Cancer Center

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Completed

  • University Health Network - Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Centre Hospitalier de l'Université de Montréal

    Montréal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • General Hospital Zadar

    Zadar, 23000
    Croatia

    Active - Recruiting

  • University Hospital Centre Zagreb

    Zagreb, 10000
    Croatia

    Active - Recruiting

  • Centrum Onkologii im. prof. F. Łukaszczyka

    Bydgoszcz, 85-796
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz

    Gdańsk, 80-214
    Poland

    Active - Recruiting

  • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o. o.

    Kraków, 30-348
    Poland

    Active - Recruiting

  • Szpital Specjalistyczny im. L. Rydygiera w Krakowie sp. z o. o.

    Kraków, 31-826
    Poland

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Completed

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Completed

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