A Study in Advanced Cancer

This study is currently recruiting participants.
Verified April 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01226485
First received: October 20, 2010
Last updated: April 11, 2014
Last verified: April 2014

October 20, 2010
April 11, 2014
September 2010
October 2014   (final data collection date for primary outcome measure)
Recommended phase 2 dose [ Time Frame: Time of first dose to time of last dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01226485 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pharmacokinetics, area under the concentration - time curve (AUC) [ Time Frame: Cycle 1 - Days 1 and 2, 15 and 16; Cycle 2 - Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Cycle 1 - Days 1 and 2, 15 and 16; Cycle 2 - Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, time of maximal concentration (Tmax) [ Time Frame: Cycle 1 - Days 1 and 2, 15 and 16; Cycle 2 - Day 1 ] [ Designated as safety issue: No ]
  • Number of patients with tumor response [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study in Advanced Cancer
A Phase 1 Dose-Escalation Study of LY2940680 in Patients With Advanced Cancer

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.

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Cancer
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.
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

Intervention: Drug: LY2940680
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2015
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
United States
 
NCT01226485
13200, I4J-MC-HHBB
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP