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A Phase 1 Study of LY2606368 in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancer, Squamous Cell Carcinoma, Carcinoma, Squamous Cell of Head and Neck, Lung Squamous Cell Carcinoma Stage IV, Anal Squamous Cell Carcinoma, Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Phase 1 Study of LY2606368 in Patients With Advanced Cancer


Part C added per protocol amendment (February, 2013).


Inclusion Criteria:



- Must be appropriate candidate for experimental therapy, as determined by
investigator, after available standard therapies have failed

- Have adequate organ function

- Prior Therapies: Systemic treatments: must have discontinued previous systemic
treatments for cancer and recovered from the acute effects of therapy. Participants
must have discontinued mitomycin-C or nitrosourea therapy at least 42 days and have
discontinued any cytotoxic therapies at least 28 days prior to study enrollment.
Radiation therapy and surgery: must be completed at least 4 weeks before study
enrollment

- Part A: Must have diagnosis of cancer that is advanced or metastatic

- Part B: Must have histologically confirmed squamous cell cancer of the head and neck
or must have squamous cell cancer of any tumor type

- Part C: Must have histological diagnosis of squamous cell cancer of the head and
neck, histological or cytological diagnosis of squamous non-small-cell lung cancer,
or histological diagnosis of Stage IIIB (N2 or N3) or Stage IV small cell cancer of
the anus that is not curable by local therapy

- Must be available during the duration of the study and willing to follow the study
procedures

- If participant is of reproductive potential, must agree to use medically approved
contraceptive precautions during the study and for three months following the last
dose of study drug

- If the participant is a female of childbearing potential, must have had a negative
serum or urine pregnancy test within 7 days of the first dose of study drug and must
not be breast feeding

Exclusion Criteria:

- Must not have taken an unapproved drug as treatment for any indication within the
last 28 days prior to starting study treatment

- Must not have an active symptomatic fungal, bacterial or viral infection, including
human immunodeficiency virus (HIV) or Hepatitis A, B, or C

- Must not have a serious heart condition, such as congestive heart failure, unstable
angina pectoris, or heart attack within the last three months

- Must not have systolic blood pressure <90 millimeters of mercury (mmHg) or recurrent
symptomatic orthostatic hypotension

- Must not have a family history of long QTc syndrome or be taking drugs known to cause
QTc prolongation or Torsades de Pointes

- Must not have a serotonin-secreting carcinoid tumor or a prior history of
drug-induced serotonin syndrome

- Must not have acute leukemia

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of a Recommended Phase 2 Dosing Regimen: Maximum Tolerated Dose (Parts A and B)

Outcome Time Frame:

Time of first dose until last dose (estimated as up to 156 weeks)

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

13129

NCT ID:

NCT01115790

Start Date:

February 2010

Completion Date:

May 2015

Related Keywords:

  • Advanced Cancer
  • Squamous Cell Carcinoma
  • Carcinoma, Squamous Cell of Head and Neck
  • Lung Squamous Cell Carcinoma Stage IV
  • Anal Squamous Cell Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Anus Neoplasms
  • Neoplasms
  • Head and Neck Neoplasms

Name

Location

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.Birmingham, Alabama  35294
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.St Joseph, Missouri  64507
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.Memphis, Tennessee  38138
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.Bedford, Texas  76022