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

Sponsor

Genus Oncology, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01279603

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

5.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: GO-203-2c	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2011

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GO-203-2c	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.

Arm

Intervention/Treatment

Experimental: GO-203-2c

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.

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [24 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TGen Clinical Research Service	Scottsdale	Arizona	United States	85258
2	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
3	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
4	University of Texas Health Science Center San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Genus Oncology, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genus Oncology, LLC

ClinicalTrials.gov Identifier:

NCT01279603

Other Study ID Numbers:

GO-2C-001

First Posted:

Jan 19, 2011

Last Update Posted:

Sep 19, 2014

Last Verified:

Sep 1, 2014

Keywords provided by Genus Oncology, LLC

Cancer

Additional relevant MeSH terms:

Lymphoma

Neoplasms

Study Results

No Results Posted as of Sep 19, 2014