Phase
Condition
Neoplasms
Sarcoma
Pancreatic Cancer
Treatment
LY2880070
Gemcitabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 metastaticdisease
Agree to use medically approved contraceptives during the study and for 3 monthsfollowing the last study treatment
All females must have a negative serum pregnancy test result, and females ofchild-bearing potential must have a negative urine pregnancy test result, prior tothe first study treatment
Have tumor lesions considered measurable by the Response Evaluation Criteria inSolid Tumors (RECIST) v1.1
Must be, in the judgment of the investigator, an appropriate candidate forexperimental therapy, and no standard therapy would confer clinical benefit
For Part A
Must have evidence of cancer (solid tumors, excluding glioblastoma and primary braintumor) 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 (perAmerican 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 anybeast 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 colorectalcancer
For Ovarian Cancer:
Must have histologically confirmed advanced or metastatic epithelialovarian cancer
Must be eligible to receive Gemzar (GEM) and not refractory toGEM/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 metastaticor locally advanced
Must have failed at least 1 prior chemotherapy
For STS:
Must have histologically confirmed STS that is metastatic or locallyadvanced
Patients with gastrointestinal stromal tumors (GIST) must have failed aKIT inhibitor
Must have failed at least 1 prior chemotherapy
For Pancreatic Cancer:
Must have histologically confirmed pancreatic cancer that is metastatic orlocally advanced
Must have failed at least 1 prior chemotherapy regimen
For Part C
Participants with high grade serous ovarian cancer (HGSOC) will be screened forspecific genetic signatures
Exclusion
Exclusion Criteria:
Have received treatment with an investigational drug which has not receivedregulatory 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 chronicactive 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 studyof 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 cervicalcancer in situ, in situ carcinoma of the bladder, basal cell carcinoma of theskin, or another in situ carcinoma that is considered cured
Study Design
Connect with a study center
Tom Baker Cancer Centre
Calgary, Alberta T2N 4N2
CanadaSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
BC Cancer Agency
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
Juravinski Cancer Center
Hamilton, Ontario L8V 5C2
CanadaSite Not Available
Ottawa Hospital Cancer Centre
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
University Health Network - Princess Margaret Hospital
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Jewish General Hospital
Montreal, Quebec H3T 1E2
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec H2X 0A9
CanadaSite Not Available
General Hospital Zadar
Zadar, 23000
CroatiaSite Not Available
University Hospital Centre Zagreb
Zagreb, 10000
CroatiaSite Not Available
Centrum Onkologii im. prof. F. Łukaszczyka
Bydgoszcz, 85-796
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
Gdańsk, 80-214
PolandSite Not Available
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o. o.
Kraków, 30-348
PolandSite Not Available
Szpital Specjalistyczny im. L. Rydygiera w Krakowie sp. z o. o.
Kraków, 31-826
PolandSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.