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A Phase I Trial of ABI-011 Administered Weekly in Patients With Advanced Solid Tumors or Lymphomas

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

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Trial Information

A Phase I Trial of ABI-011 Administered Weekly in Patients With Advanced Solid Tumors or Lymphomas

Dose limiting toxicities (DLT), maximum tolerated dose (MTD)

Inclusion Criteria:

- Must be equal or greater 18 years of age

- ECOG performance status less than or equal to 2 (Appendix 2)

- Pts. must be willing and able to sign informed consent

- Cytologically or histologically confirmed solid tumor malignancy or lymphoma for
which no standard approved therapy is available. Patients should have accessible
tumor lesions amendable to 2 serial biopsies which would not put the patient or their
treatment at risk

- Pt. agrees and is willing to provide 2 serial tumor biopsies(optional on first phase,
mandatory on 2nd phase)

- During the dose escalation phase, measurable or non-measurable disease as defined by
RECIST criteria. At 2nd phase, only patients with measurable disease

- Life expectancy of equal or greater than 12 weeks

- All AEs of any prior chemotherapy, surgery or radiotherapy, must have resolved to
grade equal to or less than 1

- The following laboratory results must be present within 14 days of initial ABI-011

- Hemoglobin greater or equal to 9g/dL

- Absolute neutrophils count(ANC)greater or equal to 1.5 x 10^9/L

- Platelet count is greater or equal to 100 x 10^9/L

- Serum bilirubin less than or equal to 1.5 x upper limit of normal (ULN)

- Aspartate transaminase (AST) and alanine transaminase (ALT)is less than or equal
to 2.5 ULN(except if liver metastases are present; then values must be less than
or equal to 5 x ULN)

- Potassium, corrected calcium and magnesium WNL

- Serum Creatinine less than or equal to 1.5 x ULN

- Activated aPTT,PT,INR,WNL

- WNL levels : Troponin I and T, CK-MB,BNP

- At least one measurable lesion should be evaluable (DCE-MRI eligibility criteria)and
meet at least one of the criteria below:

- At least one measurable lesions should be at least 3 cm in diameter and
should not be near the diaphragm or mediastinum

- Lesions should be solid masses that enhance with contrast, without signs of
calcification on the most recent computed tomography (CT) or magnetic resonance

- Pts. must be willing to practice contraceptive methods for the duration of the study
and for one month following study completion. Female patients must be postmenopausal,
surgically sterile or they must agree to use acceptable methods of birth control.
Male patients must be surgically sterile or agree to use an acceptable method of

- Women of childbearing potential must have a negative serum pregnancy
test(B-hCG)within 72 hours prior to first study drug administration

Exclusion Criteria:

- Inability to comply with study and follow-up procedures

- Women who are pregnant or lactating

- Treatment with chemotherapy, hormonal therapy(except leuprolide for prostate cancer),
immunotherapy, biologic therapy, or radiation therapy as cancer therapy within 4
weeks before initiation of study treatment. Six weeks should have elapsed if prior
chemotherapy treatment included nitrosoureas or mitomycin C

- Pts. who have received antibody-based therapies within 28 days or 5 half-lives of the
agent, whichever time period is longer

- Major surgery within 6 weeks before first study drug administration

- Prior treatment with tumor vascular disruptive agents

- Any uncontrolled medical or psychiatric risk factors

- Central nervous system(CNS)metastases.

- History of diabetic retinopathy. All patients must be evaluated by an
ophthalmologist prior to study treatment

- Any history of myopathy, either peripheral or cardiac

- Current use of medications that may have the potential of QTc prolongation

- History of allergy or hypersensitivity to any compound of the ABI-011 formulation

- Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy

- Pt.has known infection with human immunodeficiency virus (HIV),or known chronic
Hepatitis B or Hepatitis C

- Inability to be venipunctured and/or tolerate venous access

- History of other carcinoma within past 5 years

- Pts. requiring therapeutic anticoagulation with either coumadin or low molecular
weight heparin or with history of any bleeding diathesis. Low dose aspirin and low
dose coumadin for catheter maintenance are allowed

- Lung tumors in a central position.

- Cardiac exclusion criteria:

- Left ventricular ejection fraction (LVEF)< 50% by echocardiography;

- Previous history of MI or ischemic heart disease

- EKG findings suggestive of current or previous ischemic heart disease, including
left bundle branch block

- Prior treatment with chemotherapy agents known to potentially cause

- Class III or IV heart failure as defined by the New York Heart(NYHA) functional

- Congenital or acquired long QT syndrome

- Uncontrolled hypertension

- Current or past history of clinically significant arrhythmias

- QTc prolongation

- HO Symptomatic PVD (Venous or arterial)

- Seizure disease requiring current anticonvulsant treatment

- HO previous CVA or TIA

- HO inflammatory bowel disease (active or past) or active PUD

- HO previous, whole abdomen radiation therapy or more than Grade 1 residual toxicity
from previous radiation therapy.

- History of autoimmune disease or vascular disease (venous or arterial)

Type of Study:


Study Design:

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

Outcome Measure:

DLT's and MTD Safety and Toxicity profile

Outcome Description:

Evaluate PK and PD of ABI-011. Preliminary assessment of tumor response.

Outcome Time Frame:

During Cycle 1, treatment period, End of Study and Follow-Up, approximately up to 2 years

Safety Issue:


Principal Investigator

Patricia M LoRusso, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karmanos Cancer Institute Hudson-Webber Cancer Research Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

September 2014

Related Keywords:

  • Advanced Solid Tumors
  • Lymphoma
  • Neoplasms



Karmanos Cancer Center InstituteDetroit, Michigan  48201
CTRC @ The Utah Health Science Center @ San AntonioSan Antonio, Texas  78229