Overview

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

Status:
Completed
Trial end date:
2019-01-22
Target enrollment:
0
Participant gender:
All
Summary
The main purpose of this study is to evaluate the safety of ramucirumab in combination with other targeted agents in participants with advanced cancers.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Antibodies, Monoclonal
Ramucirumab
Criteria
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