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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 25, 2019
Sponsor:
Information provided by (Responsible Party):
Esperas Pharma Inc.

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.

Condition or disease Intervention/treatment Phase
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 Drug: LY2880070 Drug: Gemcitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: Part A: LY2880070
Multiple oral doses of LY2880070 during 21-day cycles
Drug: LY2880070
Capsules

Experimental: Part A: LY2880070 with Gemcitabine
Multiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles
Drug: LY2880070
Capsules

Drug: Gemcitabine
50 to 600 milligrams per square meter of body surface area (mg/m2)
Other Name: Gemzar

Experimental: Part A: LY2880070 (Metabolism Phenotype)
Multiple oral doses of LY2880070 administered during 21 day cycles, to participants who are poor metabolizers
Drug: LY2880070
Capsules

Experimental: Part B: LY2880070 and Gemcitabine (Breast)
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Drug: LY2880070
Capsules

Drug: Gemcitabine
50 to 600 milligrams per square meter of body surface area (mg/m2)
Other Name: Gemzar

Experimental: Part B: LY2880070 and Gemcitabine (Colorectal)
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Drug: LY2880070
Capsules

Drug: Gemcitabine
50 to 600 milligrams per square meter of body surface area (mg/m2)
Other Name: Gemzar

Experimental: Part B:LY2880070 and Gemcitabine (Ovarian)
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Drug: LY2880070
Capsules

Drug: Gemcitabine
50 to 600 milligrams per square meter of body surface area (mg/m2)
Other Name: Gemzar

Experimental: Part B: LY2880070 and Gemcitabine (Endometrial)
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Drug: LY2880070
Capsules

Drug: Gemcitabine
50 to 600 milligrams per square meter of body surface area (mg/m2)
Other Name: Gemzar

Experimental: Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS))
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Drug: LY2880070
Capsules

Drug: Gemcitabine
50 to 600 milligrams per square meter of body surface area (mg/m2)
Other Name: Gemzar

Experimental: Part B: LY2880070 and Gemcitabine (Pancreatic)
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Drug: LY2880070
Capsules

Drug: Gemcitabine
50 to 600 milligrams per square meter of body surface area (mg/m2)
Other Name: Gemzar




Primary Outcome Measures :
  1. Maximum Tolerated Dose(s) [ Time Frame: Baseline through Cycle 1 (Estimated up to 21 days) ]

Secondary Outcome Measures :
  1. Number of dose limiting toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (Estimated up to 21 days) ]
  2. 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) ]
  3. Peak plasma concentration (Cmax) [ Time Frame: Baseline to 24 hours post-dose (up to Day 20 in Cycle 1) ]
  4. Time to reach maximum plasma concentration (tmax) [ Time Frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1) ]
  5. Change from baseline in white blood cell count [ Time Frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1) ]
  6. Change from baseline in neutrophil count [ Time Frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1) ]
  7. Change from baseline in lymphocyte count [ Time Frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1) ]
  8. 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) ]
  9. Duration of objective response [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
  10. Best response [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
  11. Progression free survival [ Time Frame: Baseline to study completion (estimated up to 4 years) ]
  12. Overall survival [ Time Frame: Baseline up to 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632448


Contacts
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Contact: Esperas Pharma Inc.

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ketki Bhushan    617-632-4270    Ketki_Bhushan@DFCI.HARVARD.EDU   
Principal Investigator: Geoffrey Shapiro         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Jas Grewal-Karwa    313-576-8932    karwaj@karmanos.org   
Principal Investigator: Anthony Shields         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Bonnie Chalmers    (780) 432-8248    Bonnie.Chalmers@albertahealthservices.ca   
Principal Investigator: Quincy Chu         
Canada, Ontario
Juravinski Cancer Center Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Robin Eady    905-387-9711 ext 64422    ready@HHSC.CA   
Principal Investigator: Holger Hirte         
Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Deborah Keller    (613) 247-3518    djonker@toh.on.ca   
Principal Investigator: Derek Jonker         
University Health Network - Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Amit Oza    416-946-4501 ext 2818      
Principal Investigator: Amit Oza         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Wilson Miller    514-340-8222      
Principal Investigator: Wilson Miller         
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Nathaniel Bouganim    514-934-1934 ext 35800      
Contact: Rosie Santos    514 934-1934 ext: 44328    rosalia.santos@muhc.mcgill.ca   
Principal Investigator: Nathaniel Bouganim         
Centre Hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 0A9
Contact: Diane Provencher    514-890-8444    diane.provencher.chum@ssss.gouv.qc.ca   
Principal Investigator: Diane Provencher         
Sponsors and Collaborators
Esperas Pharma Inc.
Investigators
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Study Director: Email: choruspharma@lists.lilly.com Esperas Pharma Inc.

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Responsible Party: Esperas Pharma Inc.
ClinicalTrials.gov Identifier: NCT02632448     History of Changes
Other Study ID Numbers: ESPS-001
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Keywords provided by Esperas Pharma Inc.:
Metastatic cancer
Advanced cancer
Recurrent cancer
Colorectal neoplasms
Triple negative breast cancer
Ovarian neoplasms
Colon neoplasms
Rectal neoplasms
Triple negative breast neoplasms
Gastrointestinal stromal tumor
Pancreatic Neoplasms
Pancreatic Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Pancreatic Neoplasms
Sarcoma
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Digestive System Neoplasms
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases
Neoplastic Processes
Pathologic Processes
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents