ABI-009 Trial in Patients With Advanced Non-hematologic Malignancies

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 given weekly; to characterize the toxicities of ABI-009; and to determine the pharmacokinetic parameters for ABI-009 when given on a weekly schedule.

Key facts

Study ID

NCT00635284

Run by

Celgene

People needed

27

Starts

2007-12-01

Expected to finish

2011-06-01

Last updated by the study team

2019-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each subject must meet the following criteria to be enrolled in this study.
• Male and female patients with histologically or cytologically confirmed diagnosis of cancer which is not amenable to curative therapy.
• Patients with advanced non-hematologic malignancies for whom no standard therapy exists.
• Measurable disease by RECIST or evaluable disease (e.g., bone metastasis, pleural effusion, ascites, or lesions which do not fulfill RECIST criteria for metastatic disease)
• Off all therapy (inclusive of investigational therapies) for at least 4 weeks prior to study drug administration OR off all daily or weekly therapy (inclusive of investigational therapies) for at least 2 weeks prior to study drug administration and without any side effects associated with these therapies.
• Female patients of child-bearing potential must have a negative serum pregnancy test within 7 days prior to first study drug administration.
• Female patients who are postmenopausal must have 12 months of amenorrhea, surgically sterile, or must agree to the use of a physical method of non-hormonal contraception.
• Male patients must be surgically sterile or agree to the use of a barrier method of contraception.
• Life expectancy of > 3 months.
• ECOG Performance Status of 0-1.
• Patients must be able to provide informed consent indicating knowledge of his/her disease process, the investigational nature of the therapy, alternatives, benefits, and risks including potential side effects.
• Age ≥ 18 years of age.
• No major surgery within 4 weeks before treatment with ABI-009. (A biopsy is not considered major surgery).
• No chemotherapy, hormonal therapy, immunotherapy or radiotherapy within 4 weeks before treatment with ABI-009 (6 weeks for previous treatment with nitrosoureas, mitomycin, or extensive radiotherapy) and no immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
• No immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
• Required Initial Laboratory Data:
• Hemoglobin > 9.0 g/dL
• WBC ≥ 3,000/µl
• ANC ≥ 1,500/µl
• Platelet count ≥ 100,000/µl
• Total Bilirubin ≤ ULN
• SGOT (AST) SGPT (ALT) ≤ 1.5 x ULN ≤ 1.5 x ULN
• Serum Cholesterol < 350 mg/dL
• Serum Triglyceride < 300 mg/dL
• Adequate renal function with serum creatinine < 1.5 mg/dL and/or creatinine clearance (cockroft formula) ≥ 60 mL/min.

You may not qualify if…

• Subjects who meet any of the following criteria will be excluded from the study.
• Pregnant or nursing women.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition including macrolide (e.g. azithromycin, clarithromycin, dirithromycin, and erythromycin) and ketolide antibiotics.
• Patients have not recovered from adverse affects of radiation therapy or investigational agent within previous 28 days.
• Uncontrolled intercurrent illness that in the opinion of the investigator would limit compliance and tolerance to study requirements
• Patients with known brain metastases or leptomeningeal tumor involvement.
• Receiving any of the following: concomitant antitumor therapy or inhibitors of CYP3A4.
• Patients with history of interstitial lung disease and/or pneumonitis.

Where it is running

• Sarcoma Oncology Center — Santa Monica, California, United States
• University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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