Study of GO-203-2C Given Intravenously in Patients With Advanced Solid Tumors Including Lymphomas
Primary Purpose
Solid Tumors
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GO-203-2c
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumors focused on measuring Cancer
Eligibility Criteria
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
Sites / Locations
- TGen Clinical Research Service
- Cedars-Sinai Medical Center
- Beth Israel Deaconess Medical Center
- University of Texas Health Science Center San Antonio
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GO-203-2c
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01279603
First Posted
January 11, 2011
Last Updated
September 18, 2014
Sponsor
Genus Oncology, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01279603
Brief Title
Study of GO-203-2C Given Intravenously in Patients With Advanced Solid Tumors Including Lymphomas
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genus Oncology, LLC
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors
Keywords
Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GO-203-2c
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GO-203-2c
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
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
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
TGen Clinical Research Service
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Texas Health Science Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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Study of GO-203-2C Given Intravenously in Patients With Advanced Solid Tumors Including Lymphomas
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