Trial | NCT02632448  Report issue

Title

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer
A Phase 1b/2a Three-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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    229
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.
Study Started
May 16
2016
Primary Completion
Sep 30
2025
Anticipated
Study Completion
Sep 30
2025
Anticipated
Last Update
Oct 05
2023

Drug LY2880070

Capsules

Drug Gemcitabine

50 to 600 milligrams per square meter of body surface area (mg/m2)

  • Other names: Gemzar

Part A: LY2880070 Experimental

Multiple oral doses of LY2880070 during 21-day cycles

Part A: LY2880070 with Gemcitabine Experimental

Multiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles

Part A: LY2880070 (Metabolism Phenotype) Experimental

Multiple oral doses of LY2880070 administered during 21 day cycles, to participants who are poor metabolizers

Part B: LY2880070 and Gemcitabine (Breast) Experimental

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Part B: LY2880070 and Gemcitabine (Colorectal) Experimental

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Part B:LY2880070 and Gemcitabine (Ovarian) Experimental

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Part B: LY2880070 and Gemcitabine (Endometrial) Experimental

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS)) Experimental

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Part B: LY2880070 and Gemcitabine (Pancreatic) Experimental

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer) Experimental

Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)

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
No Results Posted