Breast Cancer Clinical Trial

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

Summary

The main purpose of this two-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

229

Study ID:

NCT02632448

Recruitment Status:

Recruiting

Sponsor:

Esperas Pharma Inc.

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There are 16 Locations for this study

See Locations Near You

Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada More Info
Temitope Oke
Contact
403-521-3226
[email protected]
Prafull Ghatage
Principal Investigator
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada More Info
Trish Mhonde
Contact
(780) 432-8647
[email protected]
Quincy Chu
Principal Investigator
BC Cancer Agency
Vancouver British Columbia, V5Z 4, Canada More Info
Joanne Marshall
Contact
604-877-600 X 675851
[email protected]
Yvette Drew
Principal Investigator
Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H 8, Canada
University Health Network - Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada More Info
Horace Wong
Contact
416-946-4501
[email protected]
Amit Oza
Principal Investigator
Jewish General Hospital
Montreal Quebec, H3T 1, Canada More Info
Alessandra Figueiredo de Vasconcelos
Contact
514-340-8222
[email protected]
Wilson Miller
Principal Investigator
McGill University Health Centre
Montreal Quebec, H4A 3, Canada More Info
Lucy Gilbert
Contact
514-934-1934
Mohamed Bakir
Contact
514 934-1934
[email protected]
Lucy Gilbert
Principal Investigator
Centre Hospitalier de l'Université de Montréal
Montréal Quebec, H2X 0, Canada More Info
Diane Provencher
Contact
514-890-8444
[email protected]
Diane Provencher
Principal Investigator
General Hospital Zadar
Zadar , 23000, Croatia More Info
Sara Bilić Knežević
Contact
+38523505064
[email protected]
Sara Bilić Knežević
Principal Investigator
University Hospital Centre Zagreb
Zagreb , 10000, Croatia More Info
Prim. Višnja Matković
Contact
+385146048701
[email protected]
Prim. Višnja Matković
Principal Investigator
Centrum Onkologii im. prof. F. Łukaszczyka
Bydgoszcz , 85-79, Poland More Info
Bogdan Zurawski
Contact
+48 52 374 31 09
[email protected]
Bogdan Zurawski
Principal Investigator
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
Gdańsk , 80-21, Poland More Info
Dagmara Klasa-Mazurkiewicz
Contact
+48 58 584 40 50/47
[email protected]
Dagmara Klasa-Mazurkiewicz
Principal Investigator
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o. o.
Kraków , 30-34, Poland More Info
Pawel Blecharz
Contact
+48126348238
[email protected]
Pawel Blecharz
Principal Investigator
Szpital Specjalistyczny im. L. Rydygiera w Krakowie sp. z o. o.
Kraków , 31-82, Poland More Info
Marek Jasiowka
Contact
+48(12)6468634
[email protected]
Marek Jasiowka
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

229

Study ID:

NCT02632448

Recruitment Status:

Recruiting

Sponsor:


Esperas Pharma Inc.

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