Overview

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

Status:
Withdrawn
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
All
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 alone and in combination with ABI-007.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Celgene
Celgene Corporation
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
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).