A Study Of LY2880070 In Participants With Advanced Or Metastatic Cancer

Study Overview

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

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.

N/A

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

ESPS-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-12-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-29
First Submitted that Met QC Criteria 2015-12-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-02
First Posted (ACTUAL) 2015-12-16	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Basic Science

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part A: LY2880070 Multiple oral doses of LY2880070 during 21-day cycles	DRUG: LY2880070 Capsules DRUG: Gemcitabine 50 to 600 milligrams per square meter of body surface area (mg/m2)
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)
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)
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)
EXPERIMENTAL: Part B:LY2880070 and Gemcitabine (Ovarian) Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
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)
EXPERIMENTAL: Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS)) Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
EXPERIMENTAL: Part B: LY2880070 and Gemcitabine (Pancreatic) Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)	DRUG: Gemcitabine 50 to 600 milligrams per square meter of body surface area (mg/m2)
EXPERIMENTAL: Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer) Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Primary Outcome Measures	Measure Description	Time Frame
Maximum Tolerated Dose(s)		Baseline through Cycle 1 (Estimated up to 21 days)

Secondary Outcome Measures	Measure Description	Time Frame
Number of dose limiting toxicities (DLTs)		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)		Baseline to 24-hours post dose (up to Day 20 in Cycle 1)
Peak plasma concentration (Cmax)		Baseline to 24 hours post-dose (up to Day 20 in Cycle 1)
Time to reach maximum plasma concentration (tmax)		Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in white blood cell count		Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in neutrophil count		Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in lymphocyte count		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)		Baseline to study completion (estimated up to 4 years)
Duration of objective response		Baseline to study completion (estimated up to 4 years)
Best response		Baseline to study completion (estimated up to 4 years)
Progression free survival		Baseline to study completion (estimated up to 4 years)
Overall survival		Baseline up to 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Email: Darcy.Vincett@ozmosisresearch.ca, Esperas Pharma Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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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