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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome 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

Outcome Time Frame:

24 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

GO-2C-001

NCT ID:

NCT01279603

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Solid Tumors
  • Cancer
  • Lymphoma
  • Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Cedars-Sinai Medical CenterLos Angeles, California  90048
TGen Clinical Research ServiceScottsdale, Arizona  85258
University of Texas Health Science Center San AntonioSan Antonio, Texas  78229