A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

NCT ID: NCT02632448

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 229 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-16
• Study Completion Date: 2025-04-14

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part A: LY2880070

Multiple oral doses of LY2880070 during 21-day cycles

Group Type: EXPERIMENTAL

LY2880070

Intervention Type: DRUG

Capsules

Part A: LY2880070 with Gemcitabine

Multiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles

Group Type: EXPERIMENTAL

LY2880070

Intervention Type: DRUG

Capsules

Gemcitabine

Intervention Type: DRUG

50 to 600 milligrams per square meter of body surface area (mg/m2)

Part A: LY2880070 (Metabolism Phenotype)

Multiple oral doses of LY2880070 administered during 21 day cycles, to participants who are poor metabolizers

Group Type: EXPERIMENTAL

LY2880070

Intervention Type: DRUG

Capsules

Part B: LY2880070 and Gemcitabine (Breast)

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Group Type: EXPERIMENTAL

LY2880070

Intervention Type: DRUG

Capsules

Gemcitabine

Intervention Type: DRUG

50 to 600 milligrams per square meter of body surface area (mg/m2)

Part B: LY2880070 and Gemcitabine (Colorectal)

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Group Type: EXPERIMENTAL

LY2880070

Intervention Type: DRUG

Capsules

Gemcitabine

Intervention Type: DRUG

50 to 600 milligrams per square meter of body surface area (mg/m2)

Part B:LY2880070 and Gemcitabine (Ovarian)

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Group Type: EXPERIMENTAL

LY2880070

Intervention Type: DRUG

Capsules

Gemcitabine

Intervention Type: DRUG

50 to 600 milligrams per square meter of body surface area (mg/m2)

Part B: LY2880070 and Gemcitabine (Endometrial)

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Group Type: EXPERIMENTAL

LY2880070

Intervention Type: DRUG

Capsules

Gemcitabine

Intervention Type: DRUG

50 to 600 milligrams per square meter of body surface area (mg/m2)

Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS))

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Group Type: EXPERIMENTAL

LY2880070

Intervention Type: DRUG

Capsules

Gemcitabine

Intervention Type: DRUG

50 to 600 milligrams per square meter of body surface area (mg/m2)

Part B: LY2880070 and Gemcitabine (Pancreatic)

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Group Type: EXPERIMENTAL

LY2880070

Intervention Type: DRUG

Capsules

Gemcitabine

Intervention Type: DRUG

50 to 600 milligrams per square meter of body surface area (mg/m2)

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

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Group Type: EXPERIMENTAL

LY2880070

Intervention Type: DRUG

Capsules

Gemcitabine

Intervention Type: DRUG

50 to 600 milligrams per square meter of body surface area (mg/m2)

Interventions

LY2880070

Capsules

Intervention Type: DRUG

Gemcitabine

50 to 600 milligrams per square meter of body surface area (mg/m2)

Intervention Type: DRUG

Other Intervention Names

Gemzar

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Esperas Pharma Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email: Darcy.Vincett@ozmosisresearch.ca

Role: STUDY_DIRECTOR

Esperas Pharma Inc.

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

BC Cancer Agency

Vancouver, British Columbia, Canada

Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

University Health Network - Princess Margaret Hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

General Hospital Zadar

Zadar, , Croatia

University Hospital Centre Zagreb

Zagreb, , Croatia

Centrum Onkologii im. prof. F. Łukaszczyka

Bydgoszcz, , Poland

Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz

Gdansk, , Poland

Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o. o.

Krakow, , Poland

Szpital Specjalistyczny im. L. Rydygiera w Krakowie sp. z o. o.

Krakow, , Poland

Countries

United States; Canada; Croatia; Poland

References

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)

Reference Type: RESULT

DOI: 10.1200/JCO.2020.38.15_suppl.3579 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3579-3579.

Reference Type: RESULT

DOI: 10.1200/JCO.2020.38.15_suppl.3581 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3581-3581.

Reference Type: RESULT

Huffman BM, Feng H, Parmar K, Wang J, Kapner KS, Kochupurakkal B, Martignetti DB, Sadatrezaei G, Abrams TA, Biller LH, Giannakis M, Ng K, Patel AK, Perez KJ, Singh H, Rubinson DA, Schlechter BL, Andrews E, Hannigan AM, Dunwell S, Getchell Z, Raghavan S, Wolpin BM, Fortier C, D'Andrea AD, Aguirre AJ, Shapiro GI, Cleary JM. A Phase I Expansion Cohort Study Evaluating the Safety and Efficacy of the CHK1 Inhibitor LY2880070 with Low-dose Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma. Clin Cancer Res. 2023 Dec 15;29(24):5047-5056. doi: 10.1158/1078-0432.CCR-23-2005.

Reference Type: DERIVED

PMID: 37819936 (View on PubMed)

Related Links

http://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.3581

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

Other Identifiers

ESPS-001

Identifier Type: -

Identifier Source: org_study_id