Description:
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.
Title
- Brief Title: A Study of LY2880070 in Participants With Advanced or Metastatic Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
ESPS-001
- NCT ID:
NCT02632448
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
Interventions
| Drug | Synonyms | Arms |
|---|
| LY2880070 | | Part A: LY2880070 |
| Gemcitabine | Gemzar | Part A: LY2880070 with Gemcitabine |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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) | |
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
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Maximum Tolerated Dose(s) |
| Time Frame: | Baseline through Cycle 1 (Estimated up to 21 days) |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Number of dose limiting toxicities (DLTs) |
| Time Frame: | Baseline through Cycle 1 (Estimated up to 21 days) |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24) |
| Time Frame: | Baseline to 24-hours post dose (up to Day 20 in Cycle 1) |
| Safety Issue: | |
| Description: | |
| Measure: | Peak plasma concentration (Cmax) |
| Time Frame: | Baseline to 24 hours post-dose (up to Day 20 in Cycle 1) |
| Safety Issue: | |
| Description: | |
| Measure: | Time to reach maximum plasma concentration (tmax) |
| Time Frame: | Baseline to 24 hours post dose (up to Day 20 in Cycle 1) |
| Safety Issue: | |
| Description: | |
| Measure: | Change from baseline in white blood cell count |
| Time Frame: | Baseline to 24 hours post dose (up to Day 20 in Cycle 1) |
| Safety Issue: | |
| Description: | |
| Measure: | Change from baseline in neutrophil count |
| Time Frame: | Baseline to 24 hours post dose (up to Day 20 in Cycle 1) |
| Safety Issue: | |
| Description: | |
| Measure: | Change from baseline in lymphocyte count |
| Time Frame: | Baseline to 24 hours post dose (up to Day 20 in Cycle 1) |
| Safety Issue: | |
| Description: | |
| Measure: | Number of participants with tumor response (objective response rate) as measured by the Response Evaluable Criteria in Solid Tumors (RECIST v.1.1) |
| Time Frame: | Baseline to study completion (estimated up to 4 years) |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of objective response |
| Time Frame: | Baseline to study completion (estimated up to 4 years) |
| Safety Issue: | |
| Description: | |
| Measure: | Best response |
| Time Frame: | Baseline to study completion (estimated up to 4 years) |
| Safety Issue: | |
| Description: | |
| Measure: | Progression free survival |
| Time Frame: | Baseline to study completion (estimated up to 4 years) |
| Safety Issue: | |
| Description: | |
| Measure: | Overall survival |
| Time Frame: | Baseline up to 1 year |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Esperas Pharma Inc. |
Trial Keywords
- Metastatic cancer
- Advanced cancer
- Recurrent cancer
- Colorectal neoplasms
- Triple negative breast cancer
- Ovarian neoplasms
- Colon neoplasms
- Rectal neoplasms
- Triple negative breast neoplasms
- Gastrointestinal stromal tumor
- Pancreatic Neoplasms
- Pancreatic Cancer
Last Updated
September 16, 2020
