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A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

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ClinicalTrials.gov Identifier: NCT02632448
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Esperas Pharma Inc.

Tracking Information
First Submitted Date  ICMJE December 14, 2015
First Posted Date  ICMJE December 16, 2015
Last Update Posted Date September 16, 2020
Study Start Date  ICMJE May 2016
Actual Primary Completion Date March 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
Maximum Tolerated Dose(s) [ Time Frame: Baseline through Cycle 1 (Estimated up to 21 days) ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
Maximum Tolerated Dose [ Time Frame: Baseline through Cycle 1 (Estimated up to 21 days) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • Number of dose limiting toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (Estimated up to 21 days) ]
  • Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24) [ Time Frame: Baseline to 24-hours post dose (up to Day 20 in Cycle 1) ]
  • Peak plasma concentration (Cmax) [ Time Frame: Baseline to 24 hours post-dose (up to Day 20 in Cycle 1) ]
  • Time to reach maximum plasma concentration (tmax) [ Time Frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1) ]
  • Change from baseline in white blood cell count [ Time Frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1) ]
  • Change from baseline in neutrophil count [ Time Frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1) ]
  • Change from baseline in lymphocyte count [ Time Frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1) ]
  • Number of participants with tumor response (objective response rate) as measured by the Response Evaluable Criteria in Solid Tumors (RECIST v.1.1) [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
  • Duration of objective response [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
  • Best response [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
  • Progression free survival [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
  • Overall survival [ Time Frame: Baseline up to 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
  • Number of dose limiting toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (Estimated up to 21 days) ]
  • Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24) [ Time Frame: Baseline to 24-hours post dose (up to Day 19) ]
  • Peak plasma concentration (Cmax) [ Time Frame: Baseline to 24 hours post-dose (up to Day 19) ]
  • Time to reach maximum plasma concentration (tmax) [ Time Frame: Baseline to 24 hours post dose (up to Day 19) ]
  • Change from baseline in white blood cell count [ Time Frame: Baseline to 24 hours post dose (up to Day 19) ]
  • Change from baseline in neutrophil count [ Time Frame: Baseline to 24 hours post dose (up to Day 19) ]
  • Change from baseline in lymphocyte count [ Time Frame: Baseline to 24 hours post dose (up to Day 19) ]
  • Number of participants with tumor response, as measured by the Response Evaluable Criteria in Solid Tumors (RECIST v.1.1) [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
  • Duration of response [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
  • Best response [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
  • Progression free survival [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
  • Overall survival [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY2880070 in Participants With Advanced or Metastatic Cancer
Official Title  ICMJE 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
Brief Summary The main purpose of this two-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Solid Tumors
  • Colorectal Cancer
  • Breast Cancer
  • Ovarian Cancer
  • Colon Cancer
  • Rectal Cancer
  • Neoplasms
  • Endometrial Cancer
  • Soft Tissue Sarcoma
  • Triple Negative Breast Cancer
  • Pancreas Cancer
  • Pancreatic Cancer
Intervention  ICMJE
  • Drug: LY2880070
    Capsules
  • Drug: Gemcitabine
    50 to 600 milligrams per square meter of body surface area (mg/m2)
    Other Name: Gemzar
Study Arms  ICMJE
  • Experimental: Part A: LY2880070
    Multiple oral doses of LY2880070 during 21-day cycles
    Intervention: Drug: LY2880070
  • Experimental: Part A: LY2880070 with Gemcitabine
    Multiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles
    Interventions:
    • Drug: LY2880070
    • Drug: Gemcitabine
  • Experimental: Part A: LY2880070 (Metabolism Phenotype)
    Multiple oral doses of LY2880070 administered during 21 day cycles, to participants who are poor metabolizers
    Intervention: Drug: LY2880070
  • Experimental: Part B: LY2880070 and Gemcitabine (Breast)
    Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
    Interventions:
    • Drug: LY2880070
    • Drug: Gemcitabine
  • Experimental: Part B: LY2880070 and Gemcitabine (Colorectal)
    Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
    Interventions:
    • Drug: LY2880070
    • Drug: Gemcitabine
  • Experimental: Part B:LY2880070 and Gemcitabine (Ovarian)
    Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
    Interventions:
    • Drug: LY2880070
    • Drug: Gemcitabine
  • Experimental: Part B: LY2880070 and Gemcitabine (Endometrial)
    Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
    Interventions:
    • Drug: LY2880070
    • Drug: Gemcitabine
  • Experimental: Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS))
    Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
    Interventions:
    • Drug: LY2880070
    • Drug: Gemcitabine
  • Experimental: Part B: LY2880070 and Gemcitabine (Pancreatic)
    Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
    Interventions:
    • Drug: LY2880070
    • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2019)
185
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2015)
84
Estimated Study Completion Date  ICMJE June 2021
Actual Primary Completion Date March 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 months following the last study treatment
  • All females must have a negative serum pregnancy test result, and females of child-bearing potential must have 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
  • Must be, in the judgment of the investigator, an appropriate candidate for experimental therapy, and no standard therapy would confer clinical benefit

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 (per American 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 any beast cancer that expresses <1% estrogen receptor (ER) and <1% progesterone receptor (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 ovarian cancer
      • Must be eligible to receive Gemzar (GEM) and not refractory to GEM/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 or locally advanced
      • Must have failed at least 1 prior chemotherapy
    • For STS:

      • Must have histologically confirmed STS that is metastatic or locally advanced
      • Patients with gastrointestinal stromal tumors (GIST) must have failed a KIT inhibitor
      • Must have failed at least 1 prior chemotherapy
    • For Pancreatic Cancer:

      • Must have histologically confirmed pancreatic cancer that is metastatic or locally advanced
      • Must have failed at least 1 prior chemotherapy regimen

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Esperas Pharma Inc.
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02632448
Other Study ID Numbers  ICMJE ESPS-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Esperas Pharma Inc.
Study Sponsor  ICMJE Esperas Pharma Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email: choruspharma@lists.lilly.com Esperas Pharma Inc.
PRS Account Esperas Pharma Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP