Solid TumorsPhase 1NCT00818831
A Study of QBI-139 in Subjects With Advanced Solid Tumors
A Phase 1 study testing QBI-139 in people with Solid Tumors, run by Quintessence Biosciences, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- QBI-139
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Texas M. D. Anderson Cancer Center
Houston, Texas
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: 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.
- Conditions
- Solid Tumors
- Being tested
- QBI-139
- Keywords
- Advanced, refractory solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QBI-139Drug
QBI-139 is being administered once a week over a two hour infusion in escalating doses.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the toxicity and tolerability of and the maximum tolerated dose for QBI-139 in patients with advanced refractory solid tumors.
Measured: Cycle 1 (three weeks)
Secondary outcomes (2)
To determine the patient response rate to QBI-139 using the RECIST criteria.
Measured: Duration of drug administration
To evaluate the pharmacokinetics of QBI-139
Measured: Cycles 1 and 2 (six weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quintessence Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818831
- Sponsor's protocol ID
- QBI-139 -101
- Other IDs
- CO 08912, 2009-0716
- Status last verified
- Jan 2015
- First submitted
- 7 Jan 2009
- Last updated
- 28 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Pharmacokinetic Study of QBI-139 Injection Administered by Weekly Intravenous Infusion in Patients With Refractory Malignancies
- ClinicalTrials.gov ID
- NCT00818831
- Acronym / sponsor ID
- QBI-139 -101
- Conditions
- Solid Tumors
- Keywords
- Advanced, refractory solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Quintessence Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Oct 2015 (estimated)
- First posted
- 8 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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®)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QBI-139QBI-139 is being administered once a week over a two hour infusion in escalating doses. | Drug | – |
Primary outcome
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)
2 secondary outcomes
To determine the patient response rate to QBI-139 using the RECIST criteria.
Time frame: Duration of drug administration
To evaluate the pharmacokinetics of QBI-139
Time frame: Cycles 1 and 2 (six weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
- UW Carbone Cancer Clinical Trials webpageLink provided by the sponsor.
- Phase I Clinical Trials Program at MD AndersonLink provided by the sponsor.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QBI-139 in people with Solid Tumors, run by Quintessence Biosciences, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.