Back to resultsA Study of LY2880070 in Participants With Advanced or Metastatic Cancer
Primary Purpose
Solid Tumors, Colorectal Cancer, Breast Cancer
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY2880070
Gemcitabine
Sponsored by
About this trial
This is an interventional basic science trial for Solid Tumors focused on measuring 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
Eligibility 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
Sites / Locations
- Dana Farber Cancer Institute
- Karmanos Cancer Institute
- Cross Cancer InstituteRecruiting
- Ottawa Hospital Cancer Centre
- University Health Network - Princess Margaret HospitalRecruiting
- Jewish General HospitalRecruiting
- McGill University Health CentreRecruiting
- Centre Hospitalier de l'Université de MontréalRecruiting
- General Hospital Zadar
- University Hospital Centre Zagreb
- Centrum Onkologii im. prof. F. Łukaszczyka
- Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
- Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o. o.
- Szpital Specjalistyczny im. L. Rydygiera w Krakowie sp. z o. o.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part A: LY2880070
Part A: LY2880070 with Gemcitabine
Part A: LY2880070 (Metabolism Phenotype)
Part B: LY2880070 and Gemcitabine (Breast)
Part B: LY2880070 and Gemcitabine (Colorectal)
Part B:LY2880070 and Gemcitabine (Ovarian)
Part B: LY2880070 and Gemcitabine (Endometrial)
Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS))
Part B: LY2880070 and Gemcitabine (Pancreatic)
Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer)
Arm Description
Multiple oral doses of LY2880070 during 21-day cycles
Multiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles
Multiple oral doses of LY2880070 administered during 21 day cycles, to participants who are poor metabolizers
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose(s)
Secondary Outcome Measures
Number of dose limiting toxicities (DLTs)
Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24)
Peak plasma concentration (Cmax)
Time to reach maximum plasma concentration (tmax)
Change from baseline in white blood cell count
Change from baseline in neutrophil count
Change from baseline in lymphocyte count
Number of participants with tumor response (objective response rate) as measured by the Response Evaluable Criteria in Solid Tumors (RECIST v.1.1)
Duration of objective response
Best response
Progression free survival
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02632448
Brief Title
A Study of LY2880070 in Participants With Advanced or Metastatic Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2016 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Esperas Pharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
229 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part A: LY2880070
Arm Type
Experimental
Arm Description
Multiple oral doses of LY2880070 during 21-day cycles
Arm Title
Part A: LY2880070 with Gemcitabine
Arm Type
Experimental
Arm Description
Multiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles
Arm Title
Part A: LY2880070 (Metabolism Phenotype)
Arm Type
Experimental
Arm Description
Multiple oral doses of LY2880070 administered during 21 day cycles, to participants who are poor metabolizers
Arm Title
Part B: LY2880070 and Gemcitabine (Breast)
Arm Type
Experimental
Arm Description
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Arm Title
Part B: LY2880070 and Gemcitabine (Colorectal)
Arm Type
Experimental
Arm Description
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Arm Title
Part B:LY2880070 and Gemcitabine (Ovarian)
Arm Type
Experimental
Arm Description
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Arm Title
Part B: LY2880070 and Gemcitabine (Endometrial)
Arm Type
Experimental
Arm Description
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Arm Title
Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS))
Arm Type
Experimental
Arm Description
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Arm Title
Part B: LY2880070 and Gemcitabine (Pancreatic)
Arm Type
Experimental
Arm Description
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Arm Title
Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer)
Arm Type
Experimental
Arm Description
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Intervention Type
Drug
Intervention Name(s)
LY2880070
Intervention Description
Capsules
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
50 to 600 milligrams per square meter of body surface area (mg/m2)
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose(s)
Time Frame
Baseline through Cycle 1 (Estimated up to 21 days)
Secondary Outcome Measure Information:
Title
Number of dose limiting toxicities (DLTs)
Time Frame
Baseline through Cycle 1 (Estimated up to 21 days)
Title
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)
Title
Peak plasma concentration (Cmax)
Time Frame
Baseline to 24 hours post-dose (up to Day 20 in Cycle 1)
Title
Time to reach maximum plasma concentration (tmax)
Time Frame
Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Title
Change from baseline in white blood cell count
Time Frame
Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Title
Change from baseline in neutrophil count
Time Frame
Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Title
Change from baseline in lymphocyte count
Time Frame
Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Title
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)
Title
Duration of objective response
Time Frame
Baseline to study completion (estimated up to 4 years)
Title
Best response
Time Frame
Baseline to study completion (estimated up to 4 years)
Title
Progression free survival
Time Frame
Baseline to study completion (estimated up to 4 years)
Title
Overall survival
Time Frame
Baseline up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esperas Pharma Inc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email: Darcy.Vincett@ozmosisresearch.ca
Organizational Affiliation
Esperas Pharma Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Completed
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Completed
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trish Mhonde
Phone
(780) 432-8647
Email
trish.mhonde@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Quincy Chu
Facility Name
Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Completed
Facility Name
University Health Network - Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Oza
Phone
416-946-4501
Ext
2818
First Name & Middle Initial & Last Name & Degree
Amit Oza
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Figueiredo de Vasconcelos
Phone
514-340-8222
Ext
26823
Email
alessandra.figueiredo.devasconcelos.ccomtl@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Wilson Miller
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Gilbert
Phone
514-934-1934
Ext
34049
First Name & Middle Initial & Last Name & Degree
Mohamed Bakir
Phone
514 934-1934
Ext
23980
Email
mohamed.bakir@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Lucy Gilbert
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Provencher
Phone
514-890-8444
Email
diane.provencher.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Diane Provencher
Facility Name
General Hospital Zadar
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Bilić Knežević
Phone
+38523505064
Email
sarabilicknezevic@yahoo.com
First Name & Middle Initial & Last Name & Degree
Sara Bilić Knežević
Facility Name
University Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prim. Višnja Matković
Phone
+385146048701
Email
visnja.matko@gmail.com
First Name & Middle Initial & Last Name & Degree
Prim. Višnja Matković
Facility Name
Centrum Onkologii im. prof. F. Łukaszczyka
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan Zurawski
Phone
+48 52 374 31 09
Email
bzur1@wp.pl
First Name & Middle Initial & Last Name & Degree
Bogdan Zurawski
Facility Name
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dagmara Klasa-Mazurkiewicz
Phone
+48 58 584 40 50/47
Email
dklasa@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Dagmara Klasa-Mazurkiewicz
Facility Name
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o. o.
City
Kraków
ZIP/Postal Code
30-348
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pawel Blecharz
Phone
+48126348238
Email
pawel.blecharz@interia.pl
First Name & Middle Initial & Last Name & Degree
Pawel Blecharz
Facility Name
Szpital Specjalistyczny im. L. Rydygiera w Krakowie sp. z o. o.
City
Kraków
ZIP/Postal Code
31-826
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Jasiowka
Phone
+48(12)6468634
Email
mjasiowka.bk@rydygierkrakow.pl
First Name & Middle Initial & Last Name & Degree
Marek Jasiowka
12. IPD Sharing Statement
Citations:
Citation
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)
Results Reference
result
Citation
DOI: 10.1200/JCO.2020.38.15_suppl.3579 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3579-3579.
Results Reference
result
Citation
DOI: 10.1200/JCO.2020.38.15_suppl.3581 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3581-3581.
Results Reference
result
Learn more about this trial
A Study of LY2880070 in Participants With Advanced or Metastatic Cancer
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