A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02632448
• Other study ID #: ESPS-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 16, 2016
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: Esperas Pharma Inc.
• Contact: Esperas Pharma Inc.
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 229
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Colon Cancer
• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Ovarian Cancer
• Pancreas Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Rectal Cancer
• Sarcoma
• Soft Tissue Sarcoma
• Solid Tumors
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• LY2880070
Capsules
• Gemcitabine
50 to 600 milligrams per square meter of body surface area (mg/m2)

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	University Health Network - Princess Margaret Hospital	Toronto	Ontario
Canada	BC Cancer Agency	Vancouver	British Columbia
Croatia	General Hospital Zadar	Zadar
Croatia	University Hospital Centre Zagreb	Zagreb
Poland	Centrum Onkologii im. prof. F. Lukaszczyka	Bydgoszcz
Poland	Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz	Gdansk
Poland	Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji sp. z o. o.	Kraków
Poland	Szpital Specjalistyczny im. L. Rydygiera w Krakowie sp. z o. o.	Kraków
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Esperas Pharma Inc.

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  Poland, 

References & Publications (3)

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.

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 chk

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose(s)		Baseline through Cycle 1 (Estimated up to 21 days)
Secondary	Number of dose limiting toxicities (DLTs)		Baseline through Cycle 1 (Estimated up to 21 days)
Secondary	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)
Secondary	Peak plasma concentration (Cmax)		Baseline to 24 hours post-dose (up to Day 20 in Cycle 1)
Secondary	Time to reach maximum plasma concentration (tmax)		Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Secondary	Change from baseline in white blood cell count		Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Secondary	Change from baseline in neutrophil count		Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Secondary	Change from baseline in lymphocyte count		Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Secondary	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)
Secondary	Duration of objective response		Baseline to study completion (estimated up to 4 years)
Secondary	Best response		Baseline to study completion (estimated up to 4 years)
Secondary	Progression free survival		Baseline to study completion (estimated up to 4 years)
Secondary	Overall survival		Baseline up to 1 year

External Links

•   A phase 1b study of oral chk1 inhibitor LY2880070 in combination with gemcitabine in patients with advanced or metastatic cancer: Abstract 2020 ASCO Annual Meeting