A Study of LY2801653 in Advanced Cancer



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/22/2018
Start Date:September 9, 2009
End Date:September 11, 2017

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A Phase 1 Study of LY2801653 in Patients With Advanced Cancer

Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to
participants with advanced cancer and to determine any side effects that may be associated
with LY2801653 in this participant population. Efficacy measures will be used to assess the
activity of LY2801653.

Part B- The dose determined in Part A will be used along with efficacy measures to assess the
activity of LY2801653 in participants with adenocarcinoma of the colon or rectum, head and
neck squamous cell carcinoma (HNSCC), uveal melanoma with liver metastasis, and
cholangiocarcinoma.

Part C - the objective of Part C is to determine a recommended Phase 2 dose of LY2801653 that
may be safely given to participants with HNSCC when taken with standard doses of cetuximab
Part D - the objective of Part D is to determine a recommended Phase 2 dose of LY2801653 that
may be safely given to participants with cholangiocarcinoma when taken with a standard dose
of cisplatin.

Part E - the objective of Part E is to determine a recommended Phase 2 dose of LY2801653 that
may be safely given to participants with cholangiocarcinoma when taken with gemcitabine plus
cisplatin.

Part F - the objective of Part F is to determine a recommended Phase 2 dose of LY2801653 that
may be safely given to participants with gastric cancer when taken with ramucirumab.

Parts C and D were added to the registration in November, 2013, per protocol amendment. Parts
E and F were added to the registration in February, 2015, per protocol amendment.

Inclusion Criteria:

- Part A- Diagnosed with advanced and/or metastatic cancer during dose escalation

- Part B- Diagnosed with adenocarcinoma of the colon or rectum, head and neck squamous
cell carcinoma, uveal melanoma with liver with metastasis, or cholangiocarcinoma

- Part C - Diagnosed with head and neck squamous cell carcinoma and have received at
least one prior platinum-based systemic therapy

- Part D - Diagnosed with cholangiocarcinoma and have not received more than 1 prior
systemic therapy

- Part E - Diagnosed with cholangiocarcinoma, either intrahepatic or extrahepatic, that
is unresectable, recurrent, or metastatic. Participants must not have received prior
systemic front line therapy for metastatic or resectable disease (i.e. participants
may have received adjuvant gemcitabine but have not yet received gemcitabine/cisplatin
for recurrent metastatic disease). Participants must be, in the opinion of the
investigator, an appropriate candidate for experimental therapy. Participants should
be evaluated for the need to undergo biliary drainage by stent placement prior to
study participation. Participants should have adequate biliary drainage with no
unresolved biliary obstruction.

- Part F - Histologically- or cytologically-confirmed gastric carcinoma, including
gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma (participants
with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves
the GEJ). Participants must be ramucirumab naïve. Participants must be, in the opinion
of the investigator, an appropriate candidate for experimental therapy. human
epidermal growth factor receptor 2 (HER2)/neu status should be documented, if known.

- Must be at least 18 years of age

- Adequate hematologic, renal, and liver functions

- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

- Ability to swallow capsules, with the exception of head and neck squamous cell
carcinoma participants who may have study drug crushed and administered through a
feeding tube

Exclusion Criteria:

- Have serious preexisting medical conditions that would preclude participation in the
study

- Have a chronic underlying infection

- Have symptomatic central nervous system (CNS) malignancy or metastasis

- Have current acute or chronic leukemia

- Are pregnant or lactating

- Have hepatocellular cancer, liver cirrhosis with a Child-Pugh stage of B or higher, or
have received a liver transplant

- Have a history of congestive heart failure with a New York Heart Association class
greater than 2, unstable angina, recent myocardial infarction (within 6 months of
study enrollment), transient ischemic attacks, stroke, or arterial or venous vascular
disease

- Have a QTc interval greater than 470 msec

- For participants in Part B, C, D, E, and F, a tumor tissue sample is mandatory, when
safe and feasible, for biomarker analysis
We found this trial at
7
sites
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Ariel Birnbaum
Phone: 401-444-4239
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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Philadelphia, Pennsylvania 19104
Principal Investigator: Roger Cohen
Phone: 215-662-4469
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: James Posey
Phone: 215-503-6442
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, Pennsylvania 19111
Principal Investigator: Elizabeth Plimack
Phone: 215-214-1676
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Tucson, Arizona
Principal Investigator: Daruka Mahadevan
Phone: 901-683-0055
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Tucson, AZ
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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