A Trial of ABI-010 & ABI-007 in Patients With Advanced Non-Hematologic Malignancies

Launched by CELGENE · Jan 9, 2009

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria: Each subject must meet the following criteria to be enrolled in this study:
• • 1. Pathologically confirmed advanced solid tumor malignancy.
• • 2. Measurable or evaluable advanced solid tumors.
• • 3. Patients with advanced solid tumor malignancy who failed standard therapy or for whom no standard therapy exists. Patients failing standard therapy should have received no more than 3 prior chemotherapy regimens.
• • 4. Patients must have recovered for at least 3 weeks from prior treatment regimens and have no residual toxicity \> Grade 2 (with the exception of peripheral neuropathy which must have improved to ≤ Grade 1).
• • 5. Patient should have full recovery from any reversible side effects of prior chemotherapy.
• • 6. Patient should have full recovery for at least 4 weeks since major surgery.
• • 7. ECOG performance status 0-2.
• • 8. Age ≥18 years.
• 9. Patient must have the following blood counts at Baseline:
• • WBC ≥ 3.0 x 10 cells/L.
• • ANC ≥ 1.5 x 10 cells/L.
• • Platelets ≥ 100 x 10 cells/L.
• • Hgb ≥ 9grams/dL.
• 10. Patient must have the following blood chemistry levels at Baseline:
• • AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN);
• • Total Bilirubin ≤ ULN;
• • Alkaline phosphatase ≤ 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis;
• • Creatinine ≤ 1.5 mg/dL
• • 11. Peripheral neuropathy Grade ≤ 1 by NCI CTCAE V3.0.
• • 12. Female of childbearing potential with negative serum pregnancy test within 72 hours prior to the first dose of study drug.
• • 13. Males and females with reproductive potential must agree to utilize contraception considered adequate and appropriate by the investigator (including one barrier method) for the duration of the study and for 2 months after the end of study.
• • 14. Life expectancy ≥ 3 months.
• • 15. Informed consent document has been obtained.
• • 16. 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.
• • 1. Concurrent therapy (chemotherapy, hormonal therapy, kinase inhibitors, immunotherapy, etc) for advanced solid tumor.
• • 2. Patients receiving known CYP450 3A4 inhibitors.
• • 3. Bisphosphonate therapy is allowed, however, patients should be stable on their current bisphosphonate, with no change, start or stop of treatment within 4 weeks prior to enrollment.
• • 4. Patients with known brain metastases or leptomeningeal tumor involvement should be excluded from this clinical trial.
• • 5. Uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study.
• • 6. Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris or recent myocardial infarction (within the last 6 months).
• • 7. History of other malignancy within the last 5 years which would affect the diagnosis or assessment of advanced solid tumor excluding non-melanomatous skin cancer and cervical carcinoma.
• • 8. Patients who have received an investigational drug within the previous 3 weeks.
• • 9. Patient is currently enrolled in any other clinical study in which investigational procedures are performed or investigational therapies are administered. A patient may not enroll in such clinical trials while participating in this study.
• • 10. Pregnant or nursing women.
• • 11. Patients with history of allergy or hypersensitivity to the study drug or its excipients.
• • 12. Patients with marked baseline prolongation of QT/QTc interval (\>450 milliseconds).