Status:
WITHDRAWN
A Trial of ABI-010 & ABI-007 in Patients With Advanced Non-Hematologic Malignancies
Lead Sponsor:
Celgene
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine MTD and DLT of ABI-010 given weekly every three weeks followed by one week of rest (Cycle 1). Determine MLD and DLT in combination with ABI-007; to characterize the toxicities of ABI-010 ...
Eligibility Criteria
Inclusion
- Each subject must meet the following criteria to be enrolled in this study:
- Pathologically confirmed advanced solid tumor malignancy.
- Measurable or evaluable advanced solid tumors.
- 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.
- 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).
- Patient should have full recovery from any reversible side effects of prior chemotherapy.
- Patient should have full recovery for at least 4 weeks since major surgery.
- ECOG performance status 0-2.
- Age ≥18 years.
- 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.
- 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
- Peripheral neuropathy Grade ≤ 1 by NCI CTCAE V3.0.
- Female of childbearing potential with negative serum pregnancy test within 72 hours prior to the first dose of study drug.
- 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.
- Life expectancy ≥ 3 months.
- Informed consent document has been obtained.
- 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.
- Concurrent therapy (chemotherapy, hormonal therapy, kinase inhibitors, immunotherapy, etc) for advanced solid tumor.
- Patients receiving known CYP450 3A4 inhibitors.
- 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.
- Patients with known brain metastases or leptomeningeal tumor involvement should be excluded from this clinical trial.
- 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.
- 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).
- 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.
- Patients who have received an investigational drug within the previous 3 weeks.
- 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.
- Pregnant or nursing women.
- Patients with history of allergy or hypersensitivity to the study drug or its excipients.
- Patients with marked baseline prolongation of QT/QTc interval (\>450 milliseconds).
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00820768
Start Date
April 1 2012
End Date
April 1 2014
Last Update
April 11 2018
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905