Status:
TERMINATED
Phase II Study of PX-12 in Patients With Advanced Pancreatic Cancer
Lead Sponsor:
Cascadian Therapeutics Inc.
Collaborating Sponsors:
National Cancer Institute (NCI)
Translational Genomics Research Institute
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 pa...
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 met...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00417287
Start Date
December 1 2006
End Date
April 1 2009
Last Update
May 16 2018
Active Locations (3)
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1
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
2
Arizona Cancer Center, University of Arizona
Tucson, Arizona, United States, 85724
3
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030