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A Study of LY2940680 in Japanese Participants With Advanced Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01919398
First received: August 5, 2013
Last updated: December 30, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Neoplasm Metastasis
Drug: LY2940680
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY2940680 in Japanese Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with LY2940680 Dose-Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (28 Days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Participants with a Tumor Response [ Time Frame: Baseline to study completion (estimated as 4 months) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: August 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2940680
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.
Drug: LY2940680
Administered orally

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919398

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
Japan
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. Recruiting
Shizuoka, Japan, 411-8777
Contact: Eli Lilly and Company         
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. Recruiting
Tokyo, Japan, 104-0045
Contact: Eli Lilly and Company         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01919398     History of Changes
Other Study ID Numbers: 14895, I4J-MC-HHBH
Study First Received: August 5, 2013
Last Updated: December 30, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 02, 2015