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A Phase I of ABI-010 (Nab-17-AAG) and ABI-007 (Abraxane) Administered Weekly in Patients With Advanced Non-Hematologic Malignancies

Phase 1
18 Years
Not Enrolling
Solid Tumor

Thank you

Trial Information

A Phase I of ABI-010 (Nab-17-AAG) and ABI-007 (Abraxane) Administered Weekly in Patients With Advanced Non-Hematologic Malignancies

Inclusion Criteria:

Each subject must meet the following criteria to be enrolled in this

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

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

12. Patients with marked baseline prolongation of QT/QTc interval (>450 milliseconds).

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objectives of this study are to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of ABI-010 given weekly for 3 weeks followed by 1 week of rest (Cycle 1); to determine MTD and DLTs of ABI-010 given in combination

Outcome Time Frame:

EOS and Follow-Up

Safety Issue:


Principal Investigator

Henry C. Pitot, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

April 2014

Related Keywords:

  • Solid Tumor



Mayo Clinic Rochester, Minnesota  55905