Overview

This trial is active, not recruiting.

Condition neoplasm metastasis
Treatment ly2940680
Phase phase 1
Sponsor Eli Lilly and Company
Start date August 2013
End date May 2016
Trial size 12 participants
Trial identifier NCT01919398, 14895 TRANSFERRED, I4J-MC-HHBH

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Oral LY2940680 will be administered at escalating doses (100 mg up to 400 mg) once daily in 28-day cycles. Treatment with LY2940680 may continue until disease progression, unacceptable toxicity, or other discontinuation criteria are met.
ly2940680
Administered orally

Primary Outcomes

Measure
Number of Participants with LY2940680 Dose-Limiting Toxicities (DLT)
time frame: Cycle 1 (28 Days)

Secondary Outcomes

Measure
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2640680 and a Major Metabolite of LY2940680 (LSN3185556)
time frame: Cycle 1: Predose through 24 hours post dose on Days 1 and 15. Cycle 2: Predose through 2 hours post dose on Days 1 and predose on Day 15. Cycle 3 - 4: Predose on Days 1 and 15
Pharmacokinetics (PK): Area Under the Concentration time (AUC) of LY2640680 and a Major Metabolite of LSN3185556
time frame: Cycle 1: Predose through 24 hours post dose on Days 1 and 15. Cycle 2: Predose through 2 hours post dose on Days 1 and predose on Day 15. Cycle 3 - 4: Predose on Days 1 and 15
Percentage of Participants with a Tumor Response
time frame: Baseline to study completion (estimated as 4 months)
Pharmacodynamic (PD): Gene Expression Level of Hedgehog (Hh) Regulated Genes (Including Gli1) in Skin
time frame: Baseline, 2 hours post dose on Day 15 in Cycle 1, Predose on Day 1 in Cycle 2

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title A Phase 1 Study of LY2940680 in Japanese Patients With Advanced Solid Tumors
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.