- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00818831
A Study of QBI-139 in Subjects With Advanced Solid Tumors
January 27, 2015 updated by: Quintessence Biosciences, Inc.
Phase I Safety and Pharmacokinetic Study of QBI-139 Injection Administered by Weekly Intravenous Infusion in Patients With Refractory Malignancies
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States
- The University of Texas M. D. Anderson Cancer Center
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the toxicity and tolerability of and the maximum tolerated dose for QBI-139 in patients with advanced refractory solid tumors.
Time Frame: Cycle 1 (three weeks)
|
Cycle 1 (three weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the patient response rate to QBI-139 using the RECIST criteria.
Time Frame: Duration of drug administration
|
Duration of drug administration
|
To evaluate the pharmacokinetics of QBI-139
Time Frame: Cycles 1 and 2 (six weeks)
|
Cycles 1 and 2 (six weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (ANTICIPATED)
October 1, 2015
Study Registration Dates
First Submitted
January 7, 2009
First Submitted That Met QC Criteria
January 7, 2009
First Posted (ESTIMATE)
January 8, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
January 28, 2015
Last Update Submitted That Met QC Criteria
January 27, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- QBI-139 -101
- CO 08912 (OTHER: University of Wisconsin Comprehensive Cancer Center)
- 2009-0716 (OTHER: MD Anderson)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Solid Tumors
-
Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
-
National Cancer Institute (NCI)RecruitingSolid Tumor | Refractory Solid Tumors | Malignant Solid Tumors | Other Neoplasms Solid Tumors | Pediatric Solid TumorUnited States
-
Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
-
Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
-
Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
-
Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
-
Cancer Institute and Hospital, Chinese Academy...RecruitingRefractory Solid Tumors | Relapsed Solid TumorsChina
-
Genentech, Inc.RecruitingAdvanced Solid Tumors | Metastatic Solid TumorsCanada, Korea, Republic of, United States, Brazil, Australia, Argentina, Spain, New Zealand, Poland
-
AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
Clinical Trials on QBI-139
-
AstraZenecaCompletedCrohn's DiseaseUnited States, Australia
-
AstraZenecaCompleted
-
Niiki Pharma Inc.Completed
-
National Cancer Institute (NCI)CompletedRecurrent Mycosis Fungoides and Sezary Syndrome | Refractory Mycosis Fungoides and Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIIA Mycosis... and other conditionsUnited States
-
Dance Biopharm Inc.CompletedType 2 Diabetes Mellitus
-
AbbottQuintiles, Inc.; Synexus; author! et al. BVCompletedEssential HypertensionGermany, Russian Federation, United Kingdom
-
Institut National de la Santé Et de la Recherche...Terminated