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A Phase 1 Dose-Escalation Study of LY2940680 in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancer

Thank you

Trial Information

A Phase 1 Dose-Escalation Study of LY2940680 in Patients With Advanced Cancer


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended phase 2 dose

Outcome Time Frame:

Time of first dose to time of last dose

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:

13200

NCT ID:

NCT01226485

Start Date:

September 2010

Completion Date:

June 2014

Related Keywords:

  • Advanced Cancer
  • Cancer
  • Terminal
  • Solid Tumor
  • End Stage
  • Metastatic
  • 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.Manhassaet, 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.Phoenix, Arizona  85012
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.Jacksonville, Florida  32256
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  89169
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.Tulsa, Oklahoma  74136
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.Greenville, South Carolina  29605
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