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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genus Oncology, LLC
ClinicalTrials.gov Identifier:
NCT01279603
First received: January 11, 2011
Last updated: October 22, 2012
Last verified: October 2012

January 11, 2011
October 22, 2012
January 2011
January 2013   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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
Complete list of historical versions of study NCT01279603 on ClinicalTrials.gov Archive Site
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Study of GO-203-2C Given Intravenously in Patients With Advanced Solid Tumors Including Lymphomas
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 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
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
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.
Experimental: GO-203-2c
Intervention: Drug: GO-203-2c
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
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January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01279603
GO-2C-001
Not Provided
Genus Oncology, LLC
Genus Oncology, LLC
Not Provided
Not Provided
Genus Oncology, LLC
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP