Status:
COMPLETED
ABI-009 Trial in Patients With Advanced Non-hematologic Malignancies
Lead Sponsor:
Celgene
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 fo...
Detailed Description
No extended description necessary
Eligibility Criteria
Inclusion
- 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.
- No active alcohol abuse, drug addiction, or psychotic disorders.
- No known concomitant genetic or acquired immunosuppressive diseases (such as AIDS).
- If obese, a patient must be treated with doses calculated using his/her actual BSA (The physician must be comfortable treating at the full BSA dose regardless of BSA).
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00635284
Start Date
December 1 2007
End Date
June 1 2011
Last Update
October 18 2019
Active Locations (2)
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1
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
2
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030