NCT00818831

Brief Summary

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 at least one 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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

6.8 years

First QC Date

January 7, 2009

Last Update Submit

January 27, 2015

Conditions

Solid Tumors

Keywords

Advanced, refractory solid tumors

Outcome Measures

Primary Outcomes (1)

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

    Cycle 1 (three weeks)

Secondary Outcomes (2)

  • To determine the patient response rate to QBI-139 using the RECIST criteria.

    Duration of drug administration

  • To evaluate the pharmacokinetics of QBI-139

    Cycles 1 and 2 (six weeks)

Interventions

QBI-139DRUG

QBI-139 is being administered once a week over a two hour infusion in escalating doses.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2015

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations

US(2)