A Study of Emibetuzumab in Combination With Ramucirumab (LY3009806) in Participants With Advanced Cancer



Status:Completed
Conditions:Lung Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:March 7, 2014
End Date:January 24, 2018

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A Phase 1b/2 Study of Ramucirumab in Combination With LY2875358 in Patients With Advanced Cancer

The purpose of this study is to find a recommended schedule and dose range for Emibetuzumab
when given with ramucirumab that may be safely given to participants with cancer. In Part A
of this study, escalating doses of Emibetuzumab will be given in combination with a fixed
dose of ramucirumab to evaluate the safety of the combination. After a recommended schedule
and dose range of Emibetuzumab and ramucirumab has been established, Part B of the study will
confirm safety and to see how well certain tumors respond to the combination of study drugs.
The average amount of time on study is expected to be about 6 months.


Inclusion Criteria:

- Participants must have histological or cytological confirmed diagnosis of the
following tumor types that is advanced and/or metastatic cancer and must be, in the
judgment of the investigator, an appropriate participant for experimental therapy

- Part A: Any type of solid tumor ("all comer")

- Part B1: Gastric or Gastroesophageal Junction (GEJ) adenocarcinoma

- Part B2: Hepatocellular cancer (excluding fibrolamellar carcinoma)

- Part B3: Renal cell carcinoma (any histology)

- Part B4: Non-small cell lung cancer (squamous or non-squamous)

- Have at least 1 measurable lesion outside of the central nervous system (CNS) whose
presence is assessable using standard techniques by Response Evaluation Criteria in
Solid Tumors (RECIST) version 1.1.

- Availability of a tumor sample taken after progression on the most recent line of
systemic tumor therapy or willing to undergo a tumor biopsy pre-study treatment.

- Have a performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG)
scale in Part A and ≤ 1 on the ECOG scale in Part B.

- Have adequate organ function.

- Routine urinalysis showing ≤1+ protein or protein/creatinine ratio <0.5. For
proteinuria ≥2+ or urine protein/creatinine ratio ≥0.5, 24-hour urine must be
collected and the level must be <1 gram of protein in 24 hours for subject enrollment.

- Have discontinued all previous cancer therapies and any agents that have not received
regulatory approval for any indication, for at least 21 days or 5 halflives prior to
study enrollment, whichever is shorter, and recovered from the acute effects for
therapy.

- Have an estimated life expectancy, in the judgment of the investigator, that will
permit the participant to complete 8 weeks (2 cycles) of treatment.

- Males and females with reproductive potential: Must agree to use medically approved
contraceptive precautions during the study and for at least 3 months following the
last dose of study drug. Females with childbearing potential must have had a negative
serum pregnancy test 7 days before the first dose of study drug and must not be
breast-feeding.

Exclusion Criteria:

- Have serious pre-existing medical conditions (at the discretion of the investigator,
such as severe acute or chronic medical condition or laboratory abnormality that may
increase the risk associated with study participation).

- Have a history of hypertensive crisis or hypertensive encephalopathy or current poorly
controlled hypertension despite standard medical management.

- Participant has experienced any arterial thromboembolic event (ATE), including
myocardial infarction, unstable angina pectoris, cerebrovascular accident, or
transient ischemic attack, within 6 months prior to receiving study drugs.

- Have a history of deep vein thrombosis, pulmonary embolism, or any other significant
thromboembolic event during the 3 months prior to receiving study drugs.

- Are receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin,
or similar agents. Participants receiving prophylactic, low-dose anticoagulation
therapy are eligible provided that they are on low-molecular weight heparin or oral
factor Xa inhibitors.

- The participant is receiving chronic therapy with nonsteroidal anti-inflammatory drugs
or other antiplatelet agents. Aspirin use at doses up to 325 mg/day is permitted.

- Have significant bleeding disorders, vasculitis, or had a significant bleeding episode
from the gastrointestinal (GI) tract within 3 months prior to receiving study drugs.

- Have a history of GI perforation and/or fistulae within 6 months prior to receiving
study drugs.

- Have congestive heart failure (CHF) New York Heart Association class ≥3 or symptomatic
or poorly controlled cardiac arrhythmia.

- Have undergone major surgery within 28 days prior to receiving study drugs.

- Have a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days
prior to receiving study drugs.

- Have a known active fungal, bacterial, and/or known viral infection. Hepatocellular
cancer participants with chronic viral (B or C) hepatitis are eligible if they retain
adequate liver function.

- Have liver cirrhosis with a Child-Pugh Stage of B or C.

- Have symptomatic CNS malignancy (with the exception of medulloblastoma) or metastasis.

- Have corrected QT (QTc) interval of >470 milliseconds on screening electrocardiogram
(ECG).

- Have received previous treatment with ramucirumab or Emibetuzumab, except for
participants enrolled in cohort B1 (Gastric or GEJ adenocarcinoma) and B4 (non- small
cell lung cancer) who may have received previous ramucirumab treatment.

- Known hypersensitivity to any of the treatment components of ramucirumab or
Emibetuzumab.

- Have a second primary malignancy that, in the judgment of the investigator and
sponsor, may affect the interpretation of results.

- Are pregnant or breastfeeding.

- For Part B4 (non-small cell lung cancer) only:

- The participant has radiologically documented evidence of major blood vessel
invasion or encasement by cancer

- Participants with a history of gross hemoptysis within 2 months prior to study
treatment

- The participant has radiographic evidence of intratumor cavitation, regardless of
tumor histology
We found this trial at
4
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: James Harding
Phone: 646-888-4314
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Andrew Zhu
Phone: 617-726-6603
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Peter Enzinger
Phone: 617-632-5869
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna Bendell
Phone: 615-329-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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