A Study of QBI-139 in Subjects With Advanced Solid Tumors - Full Text View

Sponsored by:	Quintessence Biosciences, Inc.
Information provided by:	Quintessence Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT00818831

Purpose

The purposes of this trial are:

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

Patients will receive QBI-139 by IV infusion over 1 hour once weekly for three weeks. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3 to 6 patients receive escalating doses of QBI-139 until the maximum tolerated dose (MTD) is determined.

Condition	Intervention	Phase
Solid Tumors	Drug: QBI-139	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

Further study details as provided by Quintessence Biosciences, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

To determine the patient response rate to QBI-139 using the RECIST criteria.
To evlauate the pharmacokinetics of QBI-139

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 study).
Ability to understand and the willingness to sign a written informed consent document.

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 procedures.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818831

Locations

United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center	Recruiting
Madison, Wisconsin, United States, 53792
Contact: UWCCC Cancer Connect 800-622-8922 uwccc@uwccc.wisc.edu
Principal Investigator: Tien Hoang
Principal Investigator: William Schelman

Sponsors and Collaborators

Quintessence Biosciences, Inc.

More Information

UW Comprehensive Cancer Center webpage This link exits the ClinicalTrials.gov site

Responsible Party:	Quintessence Biosciences, Inc.
Study ID Numbers:	QBI-139 -101, CO 08912
Study First Received:	January 7, 2009
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00818831
Health Authority:	United States: Food and Drug Administration

Keywords provided by Quintessence Biosciences, Inc.:

Advanced, refractory solid tumors

ClinicalTrials.gov processed this record on January 16, 2009