NCT02632448CompletedPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 2 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 229 (estimated)
- First submitted
- 14 Dec 2015
- Start date
- 16 May 2016
- Primary completion date
- 14 Apr 2025
- Lead sponsor
- Esperas Pharma Inc.
- Diseases
- Triple-negative breast cancer, Endometrial cancer, Pancreatic cancer, Colorectal cancer, Ovarian cancer, Sarcoma
- NCT number
- NCT02632448
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 229
- From 16 May 2016 to the primary completion date, 14 Apr 2025
- 16 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received treatment with an investigational drug which has not received regulatory approval within 21 days of first study treatment
- Have had a bone marrow transplant
- Have had radiation therapy to \>25% of bone marrow
Other illness
- Have known positive test results of human immunodeficiency virus, or have chronic active hepatitis A, B or C
- 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
Lab values
- Have a corrected QT interval (QTcB) greater than (\>) 470 milliseconds (msec) (female) or \>450 msec (male), or a history of congenital long QT syndrome
Other
- Have symptomatic central nervous system (CNS) metastasis
- Females who are pregnant or nursing
- Have participated in this study, or are currently enrolled in another clinical study of an investigational medicinal product
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tom Baker Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| University Health Network, Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| BC Cancer Agency Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| General Hospital Zadar Coordinator of this site? Confirm its status | Zadar | Croatia | Unknown status |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Centrum Onkologii im. prof. F. Łukaszczyka Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o. Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Szpital Specjalistyczny im. L. Rydygiera w Krakowie sp. z o. o. Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.