A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

Completed · Phase 1/Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02632448

Run by

Esperas Pharma Inc.

People needed

229

Starts

2016-05-16

Expected to finish

2025-04-14

Last updated by the study team

2025-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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