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A Phase 1b/2 Study With Gemcitabine and LY2157299 for Patients With Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Neoplasms, Neoplasm Metastasis, Pancreatic Cancer

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Trial Information

A Phase 1b/2 Study With Gemcitabine and LY2157299 for Patients With Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2)


Inclusion Criteria:

For both Phase 1b and Phase 2 (unless specified in the following),
patients are eligible to be included in the study only if they meet all of the following
criteria:

For Phase 1b:

- Have histological or cytological evidence of a diagnosis of cancer that is advanced
and/or metastatic disease; that is refractory to standard therapy and/or therapies
known to provide clinical benefit or for which no standard therapy exists; and/or in
which gemcitabine therapy at the proposed doses and schedule would be considered
appropriate treatment for the metastatic disease (eg, pancreatic cancer)

- Patients may have received prior chemotherapy, radiotherapy, cancer-related hormone
therapy, or other investigational therapy as treatment. There is no limit in the
number of previous lines of therapy.

For Phase 1b and Phase 2:

- Have measurable disease or non-measurable disease, defined according to Response
Evaluation Criteria In Solid Tumors (RECIST)

- Have given written informed consent prior to any study-specific procedures

- Have adequate organ function including: Hematologic: absolute neutrophil count (ANC)
greater than or equal to 1.5 x 10^9/L, platelets greater than or equal to 100 x
10^9/L, and hemoglobin greater than or equal to 9 g/dL. Hepatic: bilirubin less than
or equal to 1.5 times upper limit of normal (ULN), and alkaline phosphatase (ALP),
aspartate aminotransferase (AST), alanine aminotransferase (ALT)less than or equal to
2.5 times ULN. If the liver has tumor involvement, AST less than or equal to 5 times
ULN and ALT less than or equal to 5 times ULN are acceptable. Patients may have
endoscopic or radiologic stenting to treat biliary obstructions. If so, then
bilirubin must return to less than or equal to 1.5 times ULN and ALP, AST, and ALT to
less than or equal to 5 times ULN prior to enrollment. Renal: serum creatinine within
normal limits, less than or equal to 1.5 times ULN.

- Have a performance status of less than or equal to 2 on the Eastern Cooperative
Oncology Group (ECOG) scale

- Patients must have recovered from any Grade 3/4 toxicities of previous therapies

- Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures

- Prior radiation therapy for treatment of cancer is allowed to <25% of the bone
marrow, and patients must have recovered from the acute toxic effects of their
treatment prior to study enrollment. Prior radiation to the whole pelvis is not
allowed. Prior radiotherapy must be completed at least 4 weeks before study entry.

- Male and female patients with reproductive potential must use an approved
contraceptive method during and for 3 months after discontinuation of study
treatment. Women of childbearing potential must have a negative beta-human chorionic
gonadotropin (B-HCG) pregnancy test documented within 14 days prior to treatment. If
condoms are used as a barrier contraceptive, a spermicidal agent should be added to
ensure that pregnancy does not occur. Should a woman become pregnant or suspect she
is pregnant while participating in this study, she should inform her treating
physician immediately.

For Phase 2:

- Have histological or cytological diagnosis of adenocarcinoma of the pancreas that is
locally advanced (Stage II, III) or metastatic (Stage IV) and not amenable to
resection with curative intent. Patients with previous radical surgery for pancreatic
cancer are eligible after progression is documented. If they received adjuvant
chemotherapy or chemoradiotherapy with gemcitabine, they can be enrolled if the
treatment was completed 3 months before or longer

- Tumor tissue or unstained slides are available from original biopsy or resection or
other tumor biopsies

- Patients may have received previous adjuvant treatment with gemcitabine with or
without radiotherapy for pancreatic cancer. Adjuvant treatment must have finished at
least 6 months before enrolling.

Exclusion Criteria: Patients will be excluded from the study if they meet any of the
following criteria:

- Are currently enrolled in, or discontinued within the last 30 days from, a clinical
trial involving an investigational product or unapproved use of a drug or device
(other than the investigational product used in this study), or concurrently enrolled
in any other type of medical research judged not to be scientifically or medically
compatible with this study

- Have moderate or severe cardiac disease:

- Myocardial infarction within 6 months prior to study entry, unstable angina pectoris,
New York Heart Association (NYHA) Class III/IV congestive heart failure, or
uncontrolled hypertension

- Major abnormalities documented by echocardiography with Doppler (for example,
moderate or severe heart valve function defect and/or left ventricular ejection
fraction (LVEF) <50%, evaluation based on the institutional lower limit of normal)

- Predisposing conditions that are consistent with development of aneurysms of the
ascending aorta or aortic stress (for example, family history of aneurysms,
Marfan-Syndrome, bicuspid aortic valve, evidence of damage to the large vessels of
the heart documented by CT scan or MRI with contrast)

- Are unable to swallow tablets or capsules

- Are pregnant or breastfeeding

- Have any significant medical illnesses that, in the investigator's opinion, cannot be
adequately controlled with appropriate therapy or would compromise the patient's
ability to tolerate this therapy

- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma
in-situ), unless in complete remission and off of all therapy for that disease for a
minimum of 3 years

- Have active infection that would interfere with the study objectives or influence
study compliance

- Phase 2 only: Endocrine pancreatic tumors or ampullary cancer

- Patients with acute or chronic leukemia or with any other disease likely to have a
significant bone marrow infiltration (screening not required)

- Have previously completed or withdrawn from this study or any other study
investigating LY2157299 or any other TGF-ß inhibitor

- Have known allergy to LY2157299 or gemcitabine or any ingredient of LY2157299 or
gemcitabine formulations

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:

Phase 1b: Recommended Phase 2 dose

Outcome Time Frame:

Time of first phase 1b dose until time of last phase 1b dose (approximately 1 year)

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:

13663

NCT ID:

NCT01373164

Start Date:

December 2011

Completion Date:

August 2014

Related Keywords:

  • Neoplasms
  • Neoplasm Metastasis
  • Pancreatic Cancer
  • Neoplasms
  • Neoplasm Metastasis
  • Pancreatic Cancer
  • Neoplasms
  • Neoplasm Metastasis
  • Pancreatic 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.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.Chicago, Illinois  60674
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.Seattle, Washington  98133