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Phase I Safety and Pharmacokinetic Study of QBI-139 Injection Administered by Weekly Intravenous Infusion in Patients With Refractory Malignancies

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

Phase I Safety and Pharmacokinetic Study of QBI-139 Injection Administered by Weekly Intravenous Infusion in Patients With Refractory Malignancies

Inclusion Criteria:

- Subjects must be refractory to or intolerant of established therapy known to provide
clinical benefit for their condition, i.e., patients must not be candidates for
regimens known to provide clinical benefit.

- Patients must have measurable (as defined by Response Evaluation Criteria in Solid
Tumors (RECIST) criteria) solid tumors.

- Prior chemotherapy and radiation therapy are allowed (at least 4 weeks must have
passed from prior chemotherapy and radiotherapy (6 weeks for nitrosoureas or
mitomycin C)), provided that clinically significant toxicity related to prior
chemotherapy or radiotherapy has returned to baseline or National Cancer Institute
(NCI) Common Toxicity and Adverse Events (CTCAE) grade ≤ 2 and are not expected to
recover further. The toxicities specifically exclude alopecia.

- Age >18 years.

- ECOG performance status <2.

- Life expectancy of greater than 12 weeks, as estimated by Principal Investigator.

- Patients must have normal organ and marrow function as defined in the protocol.

- The effects of QBI-139 on the developing human fetus are unknown. Therefore, both men
and women should not attempt to conceive and women should not be pregnant or
breast-feeding while taking part in this study (or for 90 days after completing the

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Concurrent treatment with an investigational agent other than the investigational
agent(s) used in this study OR treatment within 4 weeks of study entry with any
investigational agent(s) or device(s).

- Failure to recover fully (as judged by the Investigator) from prior surgical

- Patients with known brain metastases or leptomeningeal carcinomatosis

- Patients who have had a gastrointestinal bleed requiring transfusion within the past
6 months or active Grade 2 or higher diarrhea

- Treatment with Ranpirnase (Onconase®)

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Women who are pregnant or breastfeeding

- Patients known to have HIV are ineligible

- Patients with known immunocompromised status or organ transplants will be excluded

- Patients must not have:

- unstable angina (anginal symptoms at rest) within the past 6 months or

- myocardial infarction within the past 6 months or

- new onset angina within the last 3 months.

- QT prolongation (defined as QTc >450 msec for males and QTc >470 msec for females)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To evaluate the toxicity and tolerability of and the maximum tolerated dose for QBI-139 in patients with advanced refractory solid tumors.

Outcome Time Frame:

Cycle 1 (three weeks)

Safety Issue:



United States: Food and Drug Administration

Study ID:

QBI-139 -101



Start Date:

January 2009

Completion Date:

Related Keywords:

  • Solid Tumors
  • Advanced, refractory solid tumors
  • Neoplasms



University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
The University of Texas M. D. Anderson Cancer Center Houston, Texas  77030