A Phase 1b/2a Two-Part Open-Label Multicenter Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination with Gemcitabine in Patients with Advanced or Metastatic Cancer

NOT ENROLLING
Protocol # :
18-524
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
Phase
I
Disease Sites
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Shapiro, Geoffrey, I.
Site Research Nurses
Baylies, Rosemarie
Caramella, Anne
Carey, Margaret, M.
DeGonge, Danielle
Gillen Mckay, Christine, A.
Harran, John
Hart, Kayla
Hedglin, Jennifer
Mackoul, Anna
O’Neill, Kailene
Patchel, Rachel, Alexandra
Powers, Allison
QUINN, NICHOLAS
Rang, Bethany
Rowan, Jennifer, M.

Trial Description

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.

Eligibility Requirements

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

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