- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00522652
Phase I Trial of PX-478
May 14, 2018 updated by: Cascadian Therapeutics Inc.
A Phase 1 Trial of Oral PX-478 (a HIF-1α Inhibitor) in Patients With Advanced Solid Tumors or Lymphoma
This study is being conducted to determine the safety and biologic activity of PX-478, and to allow for observation of any preliminary evidence of antitumor activity in patients with advanced metastatic cancer.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
45
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
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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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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:
- The patient has signed the informed consent and must be considered legally capable of providing his or her own consent for participation in this study.
- The patient has a histologically or cytologically confirmed diagnosis of advanced solid tumor or lymphoma and has failed or is intolerant of standard therapy.
- The patient is ≥18 years of age.
- ECOG performance status 0 to 1.
- The patient has a predicted life expectancy of at least 12 weeks.
- Patients must have discontinued prior chemotherapy or other investigational agents for at least three weeks prior to receiving the first dose of study drug (six weeks for mitomycin C, nitrosureas, vaccines, or antibody therapy) and recovered from the toxic effects of that treatment (recovered to baseline or ≤Common Toxicity Criteria for Adverse Events (CTCAE) grade 1).
- Patients must have discontinued any radiation therapy at least four weeks prior to entry into the study and have recovered from all radiation-related toxicities (recovered to baseline or ≤CTCAE grade 1).
- The patient has adequate hematologic function defined as: WBC count >3,000 cells/μL; platelets >100,000/μL; hemoglobin >9 g/dL (may be transfused to this level); ANC >1500 cells/μL.
- The patient has adequate hepatic function defined as: bilirubin <1.5 mg/dL; aspartate aminotransaminase (AST/SGOT) & alanine aminotransferase (ALT/SGPT) <2.5 x ULN or <5 x ULN if due to metastatic disease.
- The patient has adequate renal function as defined by serum creatinine level <1.5 mg/dL.
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method; abstinence) prior to study entry and for the duration of study participation. The patient, if a man, agrees to use effective contraception or abstinence.
Exclusion Criteria:
- Patients with any active infection requiring i.v. antibiotics at study entry.
- Any serious concomitant systemic disorders that in the opinion of the investigator would place the patient at excessive or unacceptable risk of toxicity.
- Surgery within the four weeks prior to the first dose of PX 478.
- Significant central nervous system (CNS) 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. In the case of previously treated brain metastases, a minimum of four weeks interval between completion of radiation therapy and registration on study with radiologic evidence of stable or responding brain metastases is required. In the setting of previous CNS metastasectomy, adequate (minimum four week) recovery from surgery and/or radiation therapy should be documented.
- Patients with a history of seizures, non-healing wounds, or arterial thrombosis.
- Patients with unstable atrial or ventricular arrhythmias requiring control by medication; any cardiac ischemic event experienced within the preceding six months; prior history of congestive heart failure requiring therapy.
- Patients who are breastfeeding or pregnant (confirmed by serum β-HCG within 10 days prior to the start of study treatment if applicable).
- Patients with total gastrectomy or partial bowel obstruction.
- Any condition that could jeopardize the safety of the patient and compliance with the protocol.
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigational Drug
Dose Escalation
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Oral formulation, dose escalation, taken on days 1 to 5 of a 21 day cycle until progression or development of unacceptable toxicity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the MTD of PX-478 administered orally on days one to five of a 21 day cycle
Time Frame: 21 days
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the safety profile of PX-478 when administered orally on days one to five of a 21 day cycle
Time Frame: 42 days
|
42 days
|
To evaluate pharmacodynamic measures of the effects of PX 478 on the HIF 1-alpha pathway, and related tumor markers
Time Frame: 42 days
|
42 days
|
To determine the PK profile of PX 478 when administered orally on days one to five of a 21 day cycle
Time Frame: 21 days
|
21 days
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To evaluate the effects of PX 478 on tumor blood flow and vascular permeability as measured by DCE MRI
Time Frame: 21 days
|
21 days
|
To evaluate the anti-tumor activity of PX 478 in patients with advanced malignancies
Time Frame: 42 days
|
42 days
|
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
August 1, 2007
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
August 28, 2007
First Submitted That Met QC Criteria
August 29, 2007
First Posted (Estimate)
August 30, 2007
Study Record Updates
Last Update Posted (Actual)
May 17, 2018
Last Update Submitted That Met QC Criteria
May 14, 2018
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PX-478-001
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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