Advanced Solid TumorPhase 1NCT02836600
A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors
A Phase 1 study testing LY3039478 in people with Advanced Solid Tumor, run by Eli Lilly and Company at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- LY3039478
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteJapan
- Study dates
- 9 Sep 2016to 30 May 2023
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic.
- In the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate.
- Performance status of less than or equal to (≤) 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Adequate organ function, including hematologic, hepatic, and renal.
- Estimated life expectancy of greater than or equal to (≥) 12 weeks.
Who cannot join
- Received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively.
- Have serious preexisting medical conditions.
- Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea.
- Have an active bacterial, fungal, and/or known viral infection.
- Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results.
Trial locations and contacts
1 site in 1 country.
Japan1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kashiwa, Chiba, 277 8577
About this study
Official title: A Phase 1 Study of LY3039478 in Japanese Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- LY3039478
- Keywords
- notch inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3039478Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 25 mg LY3039478 | Experimental | Participants received 25 milligrams (mg) of LY3039478, administered orally three times per week (TIW) in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met. Receives: Drug: LY3039478 |
| 50 mg LY3039478 | Experimental | Participants received 50 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met. Receives: Drug: LY3039478 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With LY3039478 Dose-Limiting Toxicities (DLTs)
DLT was defined as an adverse event (AE) that occurred during Cycle 1 (first 28 days) related to the study drug and met one of the following criteria per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. These criteria included: CTCAE Grade greater than or equal to (≥) 3 non-hematological toxicity, with exceptions for nausea, vomiting, or constipation, and asymptomatic electrolyte disturbances that can be controlled with standard treatment; Grade 4 hematological toxicity of greater than (>) 5 days duration; Grade ≥ 3 anemia requiring transfusion; any febrile neutropenia; neutropenia needing granulocyte-colony stimulating factors (GCSFs); Grade 3 thrombocytopenia with bleeding or requiring platelet transfusion; Grade 4 thrombocytopenia.
Measured: Cycle 1 (Up to 28 Days)
Secondary outcomes (3)
Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)
- The ORR was defined as the percentage of participants achieving either a CR or PR. Tumor response was assessed based on histology: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) was used for solid tumors, and Response Assessment in Neuro-Oncology criteria were used for glioblastoma.
- CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to <10 mm. Additionally, tumor marker results were required to have normalized. PR was defined as a decrease of at least 30% in the sum of the diameters of target lesions, using baseline diameters as the reference.
Measured: Baseline through Measured Progressive Disease (Up To 100 Weeks)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3039478
PK: Cmax of LY3039478 was reported.
Measured: Cycle 1, Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose); Cycle 1 Day 22 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose)
PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3039478
PK: AUC (0-24) of LY3039478 was reported.
Measured: Cycle 1, Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose); Cycle 1 Day 22 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start9 Sep 2016
- Primary completion5 Jul 2019
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836600
- Sponsor's protocol ID
- 16191
- Other IDs
- I6F-JE-JJCC
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2016
- Last updated
- 7 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Doi T, Tajimi M, Mori J, Asou H, Inoue K, Benhadji KA, Naito Y. A phase 1 study of crenigacestat (LY3039478), the Notch inhibitor, in Japanese patients with advanced solid tumors. Invest New Drugs. 2021 Apr;39(2):469-476. doi: 10.1007/s10637-020-01001-5. Epub 2020 Sep 16.
PubMed 32939607