A Study in Advanced Cancers Using Ramucirumab (LY3009806) and Other Targeted Agents



Status:Completed
Conditions:Colorectal Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:October 21, 2016
End Date:January 22, 2019

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An Open-Label, Phase 1a/1b Study of Ramucirumab in Combination With Other Targeted Agents in Advanced Cancers

The main purpose of this study is to evaluate the safety of ramucirumab in combination with
other targeted agents in participants with advanced cancers.


Inclusion Criteria:

- Study Arm 1:

- histopathologically confirmed advanced or metastatic colorectal cancer, excluding
primary tumors of appendiceal origin

- have at least 1 measurable lesion assessable by radiological imaging. Tumor
lesions located in a previously irradiated area are considered measureable if
progression has been demonstrated in such lesions

- have received prior second-line treatment with oxaliplatin and/or irinotecan, and
no other licensed/standard-of-care therapies are available. If the participant
has RAS wild type colorectal cancer, he or she also must have received prior
treatment with an epidermal growth factor receptor monoclonal antibody

- Study Arm 2

- pathologically confirmed mantle cell lymphoma (MCL), with (a) measurable nodal
disease on positron emission tomography computed tomography (PET-CT) per Lugano
classification. Prior to enrollment, pathology must be reviewed and confirmed at
the investigational site where the participant is entered

- have MCL that relapsed after or is refractory to (a) first-line combination
chemotherapy with or without stem cell transplant and (b) at least 1 other
locally available therapy

- provide a newly obtained tumor tissue sample. Tumor tissue biopsies may be taken
by surgical resection, core needle biopsy, or fine needle biopsy

- All Study Arms:

- have not received previous systemic therapy (including investigational agents)
targeting programmed cell death protein 1 (PD-1)/ PD-1 ligand (PDL 1) or
PD-1/PDL-2 signaling pathways. Prior therapy with other immune checkpoint
inhibitors, including but not limited to, anti-CD137 antibody or anticytotoxic
T-lymphocyte-associated antigen-4 antibody, is not permitted

- have adequate organ function

- are, in the judgment of the investigator, appropriate candidates for experimental
therapy after available standard therapies have failed to provide clinical
benefit

- have discontinued all previous treatments for cancer and recovered from the acute
effects of therapy, other than less than or equal to Grade 2 neuropathy or
nonserious and nonlife-threatening toxicities such as alopecia, altered taste,
and nail changes

- have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group
scale

- men and women must agree to the use an effective method of contraception during
the study and for at least 3 months post last dose of study drug administration.
Women of child-bearing potential must have negative serum and urine pregnancy
tests at screening and during each treatment cycle, respectively

Exclusion Criteria:

- Study Arm 1

- have a serious illness or medical condition including, but not limited to, the
following: active or uncontrolled clinically serious infection; inadequate
biliary drainage with evidence of unresolved biliary obstruction

- Study Arm 2

- have a serious illness or medical condition including, but not limited to, the
following: active or uncontrolled clinically serious infection, including chronic
viral hepatitis

- All Arms:

- have prior or concurrent malignancies, inclusive of hematologic, primary brain
tumor, sarcoma, and other solid tumors, unless in complete remission with no
therapy for a minimum of 5 years

- have active gastrointestinal (GI) disease characterized by inflammatory bowel
disease, malabsorption syndrome, or frequent Grade 2 or more diarrhea

- are pregnant or breastfeeding

- have previously documented brain metastases, leptomeningeal disease, or
uncontrolled spinal cord compression

- have experienced any of the following: a major surgical procedure, significant
traumatic injury, non-healing wound, peptic ulcer, or bone fracture less than or
equal to 28 days prior to enrollment, or placement of a subcutaneous venous
access device less than or equal to 7 days prior to the first dose of study
treatment unless the procedure is of low risk of bleeding in the judgment of the
investigator

- have an elective or a planned major surgery during the course of the trial

- have a known allergy or hypersensitivity reaction to any of the treatment
components

- have uncontrolled hypertension

- have experienced any arterial thromboembolic event within 6 months prior to
enrollment

- have experienced any Grade 3 or 4 venous thromboembolic event that is considered
by the investigator to be life threatening or that is symptomatic and not
adequately treated by anticoagulation therapy, within 6 months prior to
enrollment

- have a history of GI perforation and/or fistulae within 6 months prior to
enrollment

- have experienced any bleeding episode considered life-threatening, or any Grade 3
or 4 GI/variceal bleeding episode in the 3 months prior to enrollment requiring
transfusion or endoscopic or operative intervention

- have congestive heart failure or poorly controlled cardiac arrhythmia per New
York Heart Association Class II-IV heart disease
We found this trial at
3
sites
1802 6th Avenue South
Birmingham, Alabama 35294
(205) 934-4011
Principal Investigator: Mansoor Saleh
Phone: 205-996-1403
UAB Comprehensive Cancer Center One of the nation’s leading cancer research and treatment centers, the...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Siqing Fu
Phone: 713-792-9669
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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