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Trial record 97 of 109 for:    hedgehog

A Study of LY2940680 in Japanese Participants With Advanced Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01919398
Recruitment Status : Active, not recruiting
First Posted : August 9, 2013
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Drug: LY2940680 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY2940680 in Japanese Patients With Advanced Solid Tumors
Study Start Date : August 2013
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Participants with LY2940680 Dose-Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (28 Days) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Percentage of Participants with a Tumor Response [ Time Frame: Baseline to study completion (estimated as 4 months) ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919398


Locations
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Japan
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.
Shizuoka, Japan, 411-8777
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.
Tokyo, Japan, 104-0045
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 1-858-255-5959 Mon-Fri from 9 AM to 5 PM Pacific Time (PST) Ignyta, Inc.

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01919398     History of Changes
Other Study ID Numbers: 14895 TRANSFERRED
I4J-MC-HHBH ( Other Identifier: Eli Lilly and Company )
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

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