A Study in Advanced Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01226485
First received: October 20, 2010
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to find a recommended dose level and schedule of dosing LY2940680 that can safely be taken by patients with advanced cancer. The study will also explore the changes in a cancer marker level in skin, hair follicles, buccal cells, and tumor cells. Finally, the study will help document any antitumor activity this drug may have.


Condition Intervention Phase
Advanced Cancer
Drug: LY2940680
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study of LY2940680 in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended phase 2 dose [ Time Frame: Time of first dose to time of last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics, area under the concentration - time curve (AUC) [ Time Frame: Cycle 1: Days 1, 2, 15 and 16; Cycles 2-4: Day 1 and Day 15 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Cycle 1: Days 1, 2, 15 and 16; Cycles 2-4: Day 1 and Day 15 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, time of maximal concentration (Tmax) [ Time Frame: Cycle 1: Days 1, 2, 15 and 16; Cycles 2-4: Day 1 and Day 15 ] [ Designated as safety issue: No ]
  • Number of patients with tumor response [ Time Frame: Baseline to study completion (estimated 8 weeks or until study discontinuation) ] [ Designated as safety issue: No ]
  • Change from baseline to study completion in Basal Cell Carcinoma Questionnaire [ Time Frame: Baseline, study completion (estimated 8 weeks or until study discontinuation) ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2940680 Experimental

Part A (dose escalation: advanced solid tumors) - Daily dosing with LY2940680

Part B (dose escalation: advanced solid tumors) - Twice Daily dosing with LY2940680 (if necessary based on pharmacokinetic, pharmacodynamic and safety data)

Part C (dose expansion: advanced solid tumors) - Dose and frequency as determined by parts A and B of the study

Part D (dose expansion: advanced basal cell carcinoma) - Dose and frequency as determined by parts A and B of the study

Drug: LY2940680
50 - 1000 mg administered orally for at least two 28 day cycles. Patients who demonstrate clinical benefit may receive treatment until discontinuation criteria are met.

Detailed Description:

Participants may include those who have previously received treatment with another hedgehog smoothened (Hh/Smo) inhibitor (excluding LY2940680).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy.
  • Have the presence of measurable or nonmeasurable disease
  • Have adequate organ function, including:

    • Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 9 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin until 5 days after the erythrocyte transfusion.
    • Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), ALT, and aspartate transferase (AST) less than or equal to 2.0 times ULN. If the liver has tumor involvement AST and ALT equaling less than or equal to 5 times ULN are acceptable.
    • Renal: Serum creatinine less than or equal to 1.5 times ULN.
  • Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have discontinued previous treatments for cancer and recovered from the acute effects of therapy (for example, at least 42 days for mitomycin-C or nitrosoureas, 28 days for other chemotherapy and biologics. At the discretion of the investigator, hormone refractory prostate cancer patients who are stable on gonadotropin-releasing hormone (GnRH) agonist therapy and breast cancer patients who are stable on antiestrogen therapy (for example, an aromatase inhibitor) may continue treatment

Exclusion Criteria:

  • Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.
  • Have serious preexisting medical conditions
  • Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.
  • 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 (screening is not required)
  • Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
  • Have QTc interval of >500 msec on screening electrocardiogram
  • Patients who have previously received treatment with LY2940680
  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: NCT01226485

Locations
United States, Arizona
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.
Scottsdale, Arizona, United States, 85260
United States, California
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.
Redwood City, California, United States, 94063
United States, Colorado
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.
Aurora, Colorado, United States, 80045
United States, Florida
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.
Fort Myers, Florida, United States, 33908
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.
Tampa, Florida, United States, 33612
United States, Nevada
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.
Las Vegas, Nevada, United States, 89169
United States, New York
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.
New York, New York, United States, 10065
United States, Oklahoma
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.
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
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.
Nashville, Tennessee, United States, 37203
United States, Texas
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.
Fort Worth, Texas, United States, 76177
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.
Houston, Texas, United States, 77030
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.
Tyler, Texas, United States, 75702
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 9 AM - 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: NCT01226485     History of Changes
Other Study ID Numbers: 13200, I4J-MC-HHBB
Study First Received: October 20, 2010
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Cancer
Terminal
Solid Tumor
End Stage
Metastatic

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014