- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00417287
Phase II Study of PX-12 in Patients With Advanced Pancreatic Cancer
May 14, 2018 updated by: Cascadian Therapeutics Inc.
A Randomized Phase II Open-Label Study of Two Different Dose Levels of PX-12 in Patients With Advanced Carcinoma of the Pancreas Whose Tumors Have Progressed on Gemcitabine or on a Gemcitabine-Containing Combination
This study is being conducted to evaluate the clinical efficacy, biologic activity (inhibition of PX-12 target thioredoxin-1) and effects of an expired metabolite of PX-12 in patients with advanced pancreatic cancer.
Study Overview
Detailed Description
In a Phase I trial, PX-12 demonstrated anti-tumor activity and pharmacodynamic activity across a wide dose range.
At higher doses, one side effect of the agent was a garlic-like odor of an expired metabolite.
This study is being conducted to evaluate the clinical efficacy, biologic activity (inhibition of PX-12 target thioredoxin-1) and effects of the expired metabolite at two dose levels of PX-12.
This study will determine if the efficacy and biologic activity achieved at either of the two dose levels is sufficient to proceed to further studies without pushing to the maximally tolerated dose.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 2
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
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Arizona
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Scottsdale, Arizona, United States, 85258
- TGen Clinical Research Services at Scottsdale Healthcare
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center, University of Arizona
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Texas
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Houston, Texas, United States, 77030
- The University of Texas M.D. Anderson Cancer Center
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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:
- Histologically- or cytologically-confirmed diagnosis of advanced carcinoma of the pancreas (stage IV disease only).
- Patients whose tumor has progressed on gemcitabine or on a gemcitabine-containing combination. Patients must have received no more than two prior regimens for metastatic disease. Use of gemcitabine as a radiation sensitizer in combination with radiotherapy for localized disease will not be considered a prior gemcitabine-containing regimen if gemcitabine was received for ≤ 1 month following completion of radiotherapy. In addition, the use of 5-fluorouracil as a radiation sensitizer for localized disease will be allowed and not counted as a prior regimen if the 5-FU was continued for ≤ 1month following completion of radiotherapy.
- Karnofsky Performance Status of ≥ 70%.
- Patients must have discontinued previous anti-cancer therapy or other investigational agent at least three weeks or within 5 half lives of the drug (whichever is shorter) prior to entry into the study (six weeks for mitomycin C or nitrosureas) provided that all toxicities from prior treatment have resolved to a Grade 1 or less.
- Patients must have discontinued radiation therapy at least two weeks prior to entry into the study and have recovered from all radiation-related toxicities.
- Adequate organ function including the following:
- ANC ≥ 1500 cells/microL; platelets > 100,000/microL; hemoglobin ≥ 9 g/dL (may be transfused to this level).
- Bilirubin ≤ 2.0 mg/dL; aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤ 3.0 times institutional upper limit of normal (ULN) OR < 5 times institutional ULN if the subject has documented liver metastases.
- Creatinine ≤2.0 mg/dL.
- CA19-9 level >2 times ULN.
- Disease that is measurable by CT scan per RECIST criteria (Appendix IV).
- PET/CT or PET scan with SUV of ≥ 5.0 in at least one lesion on an 18F FDG scan.
Exclusion Criteria:
- Active infection requiring antibiotics at study entry.
- Any serious concomitant systemic disorder that in the opinion of the investigator would place the patient at excessive or unacceptable risk of toxicity.
- Patients with active (requiring continuous medical therapy) pulmonary disease (COPD, asthma) or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest X-ray or PET/CT scan.
- Significant central nervous system or psychiatric disorder(s) that preclude the ability of the patient to provide informed consent.
- Known or suspected brain metastases that have not received adequate therapy. Patients must be stable without requirement for steroids or seizure medications.
- Major surgery within 4 weeks of study entry.
- Chemotherapy/investigational drugs within 3 weeks or within 5 half lives of the drug (whichever is shorter) of study entry, provided that all toxicities from prior treatment have resolved to a Grade 1 or less.
- Inability to tolerate prophylactic (1 mg/day) coumadin.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High dose
128 mg/m2
|
3 hour intravenous infusion as a dose of either 54 mg/m2 or 128 mg/m2 daily for 5 days every three weeks.
Other Names:
|
Active Comparator: Low dose
54 mg/m2
|
3 hour intravenous infusion as a dose of either 54 mg/m2 or 128 mg/m2 daily for 5 days every three weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival and overall survival (percentage of patients alive at 6 months)
Time Frame: 6 months
|
6 months
|
Determine if there is a difference in effect on circulating Trx-1 protein levels between two dose levels of PX-12
Time Frame: 21 days
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine which of two dose levels of PX-12 causes the greatest effect on three surrogate markers of clinical activity
Time Frame: 42 days
|
42 days
|
Determine effects of two different dose levels on overall clinical response
Time Frame: 42 days
|
42 days
|
Further evaluate safety profile of PX-12
Time Frame: 21 days
|
21 days
|
Assess the effects of metabolic excretion of PX-12
Time Frame: 3 hours
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3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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
December 1, 2006
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
December 29, 2006
First Submitted That Met QC Criteria
December 29, 2006
First Posted (Estimate)
January 1, 2007
Study Record Updates
Last Update Posted (Actual)
May 16, 2018
Last Update Submitted That Met QC Criteria
May 14, 2018
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PX-12-II-01
- P01CA109552 (U.S. NIH Grant/Contract)
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.
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