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A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02632448
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : March 29, 2024
Sponsor:
Information provided by (Responsible Party):
Esperas Pharma Inc.

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 229 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1b/2a Three-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
Actual Study Start Date : May 16, 2016
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Experimental: Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer)
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


Outcome Measures
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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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
    • For Part C
    • Participants with high grade serous ovarian cancer (HGSOC) will be screened for specific genetic signatures

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
Contacts and Locations
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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 Completed
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute Completed
Detroit, Michigan, United States, 48201
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Temitope Oke    403-521-3226    Temitope.Oke@albertahealthservices.ca   
Principal Investigator: Prafull Ghatage         
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Trish Mhonde    (780) 432-8647    trish.mhonde@albertahealthservices.ca   
Principal Investigator: Quincy Chu         
Canada, British Columbia
BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Joanne Marshall    604-877-600 X 675851    joanne.marshall@bccancer.bc.ca   
Principal Investigator: Yvette Drew         
Canada, Ontario
Ottawa Hospital Cancer Centre Completed
Ottawa, Ontario, Canada, K1H 8L6
University Health Network - Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Horace Wong    416-946-4501 ext 3452    horace.wong@uhn.ca   
Principal Investigator: Amit Oza         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Alessandra Figueiredo de Vasconcelos    514-340-8222 ext 26823    alessandra.figueiredo.devasconcelos.ccomtl@ssss.gouv.qc.ca   
Principal Investigator: Wilson Miller         
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Lucy Gilbert    514-934-1934 ext 34049      
Contact: Mohamed Bakir    514 934-1934 ext 23980    mohamed.bakir@muhc.mcgill.ca   
Principal Investigator: Lucy Gilbert         
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         
Croatia
General Hospital Zadar Recruiting
Zadar, Croatia, 23000
Contact: Sara Bilić Knežević    +38523505064    sarabilicknezevic@yahoo.com   
Principal Investigator: Sara Bilić Knežević         
University Hospital Centre Zagreb Recruiting
Zagreb, Croatia, 10000
Contact: Prim. Višnja Matković    +385146048701    visnja.matko@gmail.com   
Principal Investigator: Prim. Višnja Matković         
Poland
Centrum Onkologii im. prof. F. Łukaszczyka Recruiting
Bydgoszcz, Poland, 85-796
Contact: Bogdan Zurawski    +48 52 374 31 09    bzur1@wp.pl   
Principal Investigator: Bogdan Zurawski         
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz Recruiting
Gdańsk, Poland, 80-214
Contact: Dagmara Klasa-Mazurkiewicz    +48 58 584 40 50/47    dklasa@gumed.edu.pl   
Principal Investigator: Dagmara Klasa-Mazurkiewicz         
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o. o. Recruiting
Kraków, Poland, 30-348
Contact: Pawel Blecharz    +48126348238    pawel.blecharz@interia.pl   
Principal Investigator: Pawel Blecharz         
Szpital Specjalistyczny im. L. Rydygiera w Krakowie sp. z o. o. Recruiting
Kraków, Poland, 31-826
Contact: Marek Jasiowka    +48(12)6468634    mjasiowka.bk@rydygierkrakow.pl   
Principal Investigator: Marek Jasiowka         
Sponsors and Collaborators
Esperas Pharma Inc.
Investigators
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Study Director: Email: Darcy.Vincett@ozmosisresearch.ca Esperas Pharma Inc.
More Information
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Additional Information:

Publications of Results:
W.H. Miller, A.F. Shields, D. Provencher, L. Gilbert, G. Shapiro, A.M. Oza, J. Spratlin, S. Lheureux, G. Bhat, S. Salvador, P. Nunes, S. Lau, I. Weiner, J. Keene, S. Zaknoen, P. Smith, J. Stille, D. Vincett, Q.S-C. Chu, 537P A phase I/II study of oral chk1 inhibitor LY2880070 in combination with low-dose gemcitabine in patients with advanced or metastatic ovarian cancer, Annals of Oncology, Volume 33, Supplement 7, 2022, Pages S793-S794, ISSN 0923-7534, https://doi.org/10.1016/j.annonc.2022.07.665. (https://www.sciencedirect.com/science/article/pii/S0923753422025169)
DOI: 10.1200/JCO.2020.38.15_suppl.3579 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3579-3579.
DOI: 10.1200/JCO.2020.38.15_suppl.3581 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3581-3581.

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Responsible Party: Esperas Pharma Inc.
ClinicalTrials.gov Identifier: NCT02632448    
Other Study ID Numbers: ESPS-001
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: March 29, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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
Neoplasms
Pancreatic Neoplasms
Sarcoma
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Digestive System Neoplasms
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
 Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Uterine Neoplasms
Uterine Diseases
Neoplastic Processes
Pathologic Processes
Gemcitabine
Antimetabolites, Antineoplastic