Clinical trial NCT02836600: A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors
Official title: A Phase 1 Study of LY3039478 in Japanese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: notch inhibitor
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-07-19
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* 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 ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Adequate organ function, including hematologic, hepatic, and renal.
* Estimated life expectancy of ≥12 weeks.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants with LY3039478 Dose-Limiting Toxicities (DLTs)
timeFrame: Cycle 1 (28 days)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles)
measure: PK: Area Under the Curve (AUC) of LY3039478
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles)
measure: Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline through Disease Progression or Death (estimated at up to 9 months)
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: 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.
state: Chiba
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.