ABI-009 Trial in Patients With Advanced Non-hematologic Malignancies
Study Details
Study Description
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 for ABI-009 when given on a weekly schedule.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
No extended description necessary
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ABI-009
|
Drug: ABI-009
nab-rapamycin
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 administered weekly and pharmacokinetic parameters for ABI-009. [End of Study (EOS) and Follow Up]
Secondary Outcome Measures
- Efficacy of ABI-009 in this patient population [End of Study (EOS) and Follow Up]
Eligibility Criteria
Criteria
Inclusion Criteria:
Each subject must meet the following criteria to be enrolled in this study.
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Male and female patients with histologically or cytologically confirmed diagnosis of cancer which is not amenable to curative therapy.
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Patients with advanced non-hematologic malignancies for whom no standard therapy exists.
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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)
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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.
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Female patients of child-bearing potential must have a negative serum pregnancy test within 7 days prior to first study drug administration.
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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.
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Male patients must be surgically sterile or agree to the use of a barrier method of contraception.
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Life expectancy of > 3 months.
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ECOG Performance Status of 0-1.
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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.
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Age ≥ 18 years of age.
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No major surgery within 4 weeks before treatment with ABI-009. (A biopsy is not considered major surgery).
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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).
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No immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
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Required Initial Laboratory Data:
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Hemoglobin > 9.0 g/dL
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WBC ≥ 3,000/µl
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ANC ≥ 1,500/µl
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Platelet count ≥ 100,000/µl
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Total Bilirubin ≤ ULN
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SGOT (AST) SGPT (ALT) ≤ 1.5 x ULN ≤ 1.5 x ULN
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Serum Cholesterol < 350 mg/dL
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Serum Triglyceride < 300 mg/dL
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Adequate renal function with serum creatinine < 1.5 mg/dL and/or creatinine clearance (cockroft formula) ≥ 60 mL/min.
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No active alcohol abuse, drug addiction, or psychotic disorders.
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No known concomitant genetic or acquired immunosuppressive diseases (such as AIDS).
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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 Criteria:
Subjects who meet any of the following criteria will be excluded from the study.
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Pregnant or nursing women.
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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.
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Patients have not recovered from adverse affects of radiation therapy or investigational agent within previous 28 days.
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Uncontrolled intercurrent illness that in the opinion of the investigator would limit compliance and tolerance to study requirements
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Patients with known brain metastases or leptomeningeal tumor involvement.
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Receiving any of the following: concomitant antitumor therapy or inhibitors of CYP3A4.
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Patients with history of interstitial lung disease and/or pneumonitis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sarcoma Oncology Center | Santa Monica | California | United States | 90403 |
| 2 | University of Texas M.D. Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Celgene
Investigators
- Principal Investigator: Ana M. Gonzalez, MD, M.D. Anderson Cancer Center
- Principal Investigator: Sant P. Chawla, MD, Sarcoma Oncology Center
Study Documents (Full-Text)
None provided.More Information
Publications
- CA401
- NCT00573677