Study of GO-203-2C Given Intravenously in Patients With Advanced Solid Tumors Including Lymphomas

Conditions:Cancer, Lymphoma
Therapuetic Areas:Oncology
Age Range:Any
Start Date:January 2011

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A Phase 1, Multi-center, Open-label, Dose-escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GO-203-2c Given Intravenously Daily X21 Repeated Every 28 Days in Patients With Advanced Solid Tumors Including Lymphomas

This clinical trial is about testing GO-203-2c, which is a newly discovered compound that
binds to an oncoprotein (a cancer causing protein) called MUC1 (which is over-expressed in
many cancers). By binding to MUC1, GO-203-2c eventually causes tumor cell death in
laboratory studies.

This study is being done to:

- Test the safety of GO-203-2c and see what effects (good and bad) it has on you and your

- Find the highest dose of GO-203-2c that can be given without causing bad side effects

- Examine how much GO-203-2c is in the blood at certain times after it is given and how
quickly the body gets rid of it

- Observe whether there is any effect of GO-203-2c on the size and activity of cancer in
your body

Inclusion Criteria:

- Histologically confirmed solid tumors or lymphomas

- Tumor progression observed after receiving standard/approved systemic chemotherapy
and/or immunotherapy including monoclonal antibodies, or when there is no approved or
effective therapy

- One or more measureable tumors by radiological evaluation

- Karnofsky performance ≥ 70%

- Life expectancy of ≥ 3 months

- Age ≥ 18 years

- Signed, written IRB-approved informed consent

- Negative pregnancy test (if female)

- Adequate liver function:

- Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)

- AST (SGOT), ALT (SGPT) and Alkaline phosphatase less than or equal to 2.5 x ULN (if
liver metastases are present, then less than or equal to 5 x ULN is allowed)

- Adequate renal function:

- Serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60
mL/min/1.73 m2 for patients with serum creatinine above institutional ULN.

- Corrected serum calcium ≥ lower limit of the institutional normal range (LLN)

- Serum phosphorus level ≥ LLN

- Adequate hematologic function:

- Absolute Neutrophil Count ≥ 1500 cells/mm3

- Platelet count ≥ 100,000 (cells/mm3)

- Hemoglobin ≥ 9 g/dL

- Urinalysis:

- No clinically significant abnormalities

- Adequate coagulation function:

- PT ≤ 1.25 x ULN

- PTT ≤ 1.25 x ULN

- For men and women of child-producing potential, agreement to use effective
contraceptive methods during the study

Exclusion Criteria:

- New York Heart Association Class III or IV, cardiac disease, myocardial infarction
within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG

- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic

- Pregnant or nursing women. NOTE: Women of childbearing potential and men must agree
to use adequate contraception (hormonal or barrier method of birth control; or
abstinence) prior to study entry and for the duration of study participation. Should
a woman become pregnant or suspect that she is pregnant while participating in this
study, she should inform her treating physician immediately.

- Major surgery within 4 weeks prior to Day 1, or not fully recovered by Day 1

- Minor surgery within 2 weeks prior to Day 1, or not fully recovered by Day 1

- Treatment with radiation therapy within 4 weeks prior to Day 1.

- Received systemic chemotherapy or monoclonal antibody or other immunotherapy within 4
weeks prior to Day 1 (exceptions: 6 weeks for nitrosourea, mitomycin C, or any agent
with a known treatment effect > 4 weeks' duration), or not fully recovered from any
side effects from previous therapy by Day 1

- History of allergic reactions attributed to excipients or chemical products used in
the final GO-203-2c drug formulation

- Known infection with HIV, hepatitis B, or hepatitis C.

- Subjects with risk factors for gastrointestinal perforation or pulmonary hemorrhage
(e.g. unresected luminal intestinal cancers; abdominal carcinomatosis within 3 months
before the first dose of study drug, abdominal fistula, acute diverticulitis, peptic
ulcer disease, irritable bowel syndrome, Crohn's disease, pulmonary hemorrhage,
hemoptysis, or tuberculosis)

- Currently receiving or having received treatment with any other investigational agent
within 4 weeks prior to Day 1, or not fully recovered from toxicities of prior
treatment by Day 1

- Serious and/or poorly controlled non-malignant disease (including but not limited to,
ongoing or active infection, hydronephrosis, hypertension, diabetes, or other
conditions) that could compromise protocol objectives in the opinion of the
Investigator and/or the sponsor. Patients with such conditions should be discussed
with the Medical Monitor prior to enrollment. All medical conditions must be NCI
CTCAE Grade 1 or lower at baseline.

- Unwillingness or inability to comply with requirements of this protocol
We found this trial at
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
Los Angeles, CA
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330 Brookline Ave
Boston, Massachusetts 02215
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
Boston, MA
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San Antonio, TX
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Scottsdale, Arizona 85258
Scottsdale, AZ
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