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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279603
• Other study ID #: GO-2C-001
• Status: Completed
• Phase: Phase 1
• First received: January 11, 2011
• Last updated: September 18, 2014
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: September 2014
• Source: Genus Oncology, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 cancer

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 therapy

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• GO-203-2c
GO-203-2c Injection is a non-preserved, sterile, ready-to-use liquid dosage form provided in a glass vial with rubber closure and crimp seal. Injection will be added to the contents of an intravenous bag (of 0.9% NS, D5W or sterile water) to a final concentration of between 0.03 - 0.3 mg/ml (preferable in 100 mls or greater) and administered as a single agent intravenously over 60 minutes. A treatment cycle will consist of a daily IV dose administered for 21 consecutive days followed by a 7 day rest.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Texas Health Science Center San Antonio	San Antonio	Texas
United States	TGen Clinical Research Service	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Genus Oncology, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	To determine the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of GO-203-2c - To establish the dose of GO-203-2c recommended for future phase II protocols	24 months	Yes