Clinical trial NCT01919398: A Study of LY2940680 in Japanese Participants With Advanced Cancers
Official title: A Phase 1 Study of LY2940680 in Japanese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm Metastasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-08-09
Enrollment: 19
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 primary purpose of this study is to assess the safety and tolerability of LY2940680 up to the global recommended dose in Japanese participants with advanced solid cancers.


Eligibility criteria: Inclusion Criteria:

* Have histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic. The participant must be, in the judgment of the investigator, an appropriate candidate for the experimental therapy after available standard therapies have failed to provide clinical benefit for their disease
* Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors Guideline Version 1.1
* Have adequate organ function
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy for at least 3 weeks (6 weeks for mitomycin-C or nitrosoureas, 2 weeks for palliative radiation therapy for bone metastasis) prior to study enrollment, and have recovered from the acute effects of any such therapy
* Males must agree to use medically approved barrier contraceptive precautions during the study and for 6 months following the last dose of study drug
* Females with child bearing potential must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of study drug; have had a negative serum pregnancy test ≤7 days before the first dose of study drug
* A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, the female must stop breastfeeding from the day of the first study drug administration until at least 6 months after the last administration
* Have an estimated life expectancy, in the judgment of the investigator, which will permit the participant to complete 2 cycles of treatment
* Are able to swallow tablets

Exclusion Criteria:

* Have received treatment within 21 days of the study enrollment with any agent that has not received regulatory approval for any indication
* Have symptomatic central nervous system (CNS) malignancy or metastasis. Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function and off steroids after cranial irradiation ending at least 14 days prior to enrollment, or after surgical resection performed at least 28 days prior to enrollment
* Have known current hematologic malignancies or acute or chronic leukemia
* Have a known active fungal, bacterial, and/or known viral infection including human immunodeficiency (HIV) or viral (A, B, or C) hepatitis, potentially affecting the conduct of this study
* Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
* Have QTc interval of \>470 milliseconds (msec) on screening electrocardiogram (ECG)
* Have serious preexisting medical conditions or serious concomitant systemic disorders that, in the opinion of the investigator, would preclude participation in this study
* Have received any medication that is a strong inhibitor of cytochrome P4503A4 (CYP3A4) within 7 days prior to receiving study drug

Primary outcomes:
measure: Number of Participants With LY2940680 Dose-Limiting Toxicities (DLT)
timeFrame: Cycle 1 (28 Days)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556)
timeFrame: Cycle1 Day1: Predose, 0.5,1,2,4, 6, 8, 10-12 hours; Cycle 1 Day15: Predose, 0.5,1,2,4, 6, 8, 10-12 hours
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve From 0 to 24 Hours (AUC[0-24]) of LY2940680 and a Major Metabolite of LSN3185556
timeFrame: Cycle1 Day1: Predose, 0.5,1,2,4, 6, 8, 10-12 hours; Cycle 1 Day15: Predose, 0.5,1,2,4, 6, 8, 10-12 hours
measure: Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])
timeFrame: Baseline Until Disease Progression or Death Due to Any Cause (Up to 29 Months)
measure: Pharmacodynamic (PD): Percentage Change From Baseline in Gene Expression Level of Hedgehog (Hh) Regulated Genes (Gli1) in Skin
timeFrame: Baseline, Cycle 1 Day15
Other outcomes:
Locations:
city: Shizuoka
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri from 9 AM to 5 PM Pacific Time (PST), or speak with your personal physician.
city: Tokyo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri from 9 AM to 5 PM Pacific Time (PST), or speak with your personal physician.
Study officials:
affiliation: Hoffmann-La Roche
name: 1-858-255-5959 Mon-Fri from 9 AM to 5 PM Pacific Time (PST)
role: STUDY_DIRECTOR
References: