A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

  • STATUS
    Recruiting
  • days left to enroll
    14
  • participants needed
    185
  • sponsor
    Esperas Pharma Inc.
Updated on 26 January 2021
cancer
estrogen
serum pregnancy test
breast cancer
treatment regimen
progesterone
KIT
metastasis
carboplatin
gemcitabine
HER2
metastatic colorectal cancer
chemotherapy regimen
primary cancer
cancer chemotherapy
glioblastoma multiforme
solid tumour
triple negative breast cancer
ovarian cancer
progesterone receptor
erbb2
estrogen receptor
solid neoplasm
sarcoma
investigational treatment
mammogram
ovarian epithelial cancer
endometrial carcinoma
soft tissue sarcoma
ovarian epithelial carcinoma
cancer of the ovary
epithelial ovarian cancer
gemzar
gastrointestinal stromal tumor
stromal tumor

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.

Details
Condition Pancreatic Cancer, Ovarian disorder, Colorectal Cancer, Connective and Soft Tissue Neoplasm, Endometrial Carcinoma, Rectal disorder, Rectal Cancer, Uterine Cancer, Cancer, Pancreatic disorder, Breast Cancer, Ovarian Cancer, Malignant neoplasm of colon, Neoplasm of unspecified nature of digestive system, Sarcoma, Diet and Nutrition, Chronic Diarrhea, Pancreatic Disorders, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, All Solid Tumors, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Colon Cancer Screening, Cancer/Tumors, Rectal Disorders, Solid Tumors, Colon cancer; rectal cancer, Ovarian Function, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Solid Neoplasm, Breast Cancer Diagnosis, Ewing's Family Tumors, Brain Function, Recurrent Respiratory Papillomatosis, Recurrent Ovarian Cancer, Solid Tumour, Razor Bumps (Pseudofolliculitis Barbae), Cancer (Pediatric), Sarcoma (Pediatric), Islet Ce417ll Cancer, Metastatic Triple-Negative Breast Cancer, Colon Cancer, Endometrial Cancer, Neoplasms, Digestive System Neoplasms, Soft Tissue Sarcoma, breast carcinoma, colorectal neoplasm, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, colon carcinoma, sarcomas, soft tissue sarcomas, cancer, breast, colorectal cancers, cancer of the pancreas, ovarian tumors, pancreatic cancers, cancer, pancreatic, cancer, colorectal, colorectal tumor, tumors, colorectal, rectal carcinoma
Treatment Gemcitabine, LY2880070
Clinical Study IdentifierNCT02632448
SponsorEsperas Pharma Inc.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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