- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00731861
Phase I, Pharmacokinetic, Pharmacodynamic Trial of PTK787 and Paclitaxel in Combination for Advanced Solid Tumors
September 10, 2014 updated by: Indiana University School of Medicine
This study will evaluate PTK787, a new oral drug that stops blood vessel development, in combination with Paclitaxel in patients with advanced solid tumors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
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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Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Simon 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:
- Adult patients with histologically confirmed malignancy that is unresponsive to curative therapy and for which no conventional therapy exists
- ECOG Performance Status 0-2
- Measurable or evaluable disease
- Laboratory values within protocol limits within 2 weeks prior to registration
- Life expectancy ≥ 12 weeks
- Patient or guardian must have written informed consent obtained according to local guidelines
- Women of child-bearing potential (non-sterile) must use appropriate barrier contraception for duration of study (negative pregnancy test required at baseline). Oral contraceptives will not be an acceptable form of contraception
- Patients may have received prior standard taxane therapy, but have never progressed on taxane-based therapy.
Exclusion Criteria:
- History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
- Prior chemotherapy ≤ 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
- Prior biologic or immunotherapy ≤ 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
- Prior full pelvic field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization.
- Major surgery (i.e., laparotomy) ≤ 4 weeks prior to randomization. Minor surgery ≤ 2 weeks prior to randomization.
- Patients who have received investigational drugs ≤ 4 weeks prior to registration
- Prior therapy with anti-VEGF agents
- Peripheral neuropathy with functional impairment ≥ CTC grade 2 neuropathy, regardless of causality
- Pleural effusion or ascites that causes respiratory compromise (≥ CTC grade 2 dyspnea)
- Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control.
- Patient agrees to avoid grapefruit (juice and fruit)
Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
- Unstable angina pectoris
- Congestive heart failure greater than NYHA classification ≥ Grade 1 (can be controlled with medication)
- Myocardial infarction ≤ 6 months prior to registration and/or randomization
- Serious uncontrolled cardiac arrhythmia
- Uncontrolled diabetes at discretion of investigator
- Active or uncontrolled infection requiring intravenous antibiotics
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Patients at risk of QT prolongation such as patients with congenital long QT syndrome or with long QTc at baseline (i.e. QTc greater than 450 msec in males, and greater than 470 msec in females) will be excluded
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Paclitaxel plus PTK787
|
Paclitaxel will be given on days 1 and 15 over 28 days in cycle 1 with PTK787 on days 3 to 28. PTK787 WILL BE TAKEN AT NIGHT. In cycle 2 and beyond, paclitaxel will be given on days 1, 8 and 15 every 28 days . PTK787 will be taken orally NIGHTLY. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the safety and tolerability of escalating doses of paclitaxel in combination with PTK787
Time Frame: Baseline through End of Study
|
Baseline through End of Study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the pharmacokinetics of paclitaxel alone and in combination with PTK787 from patients with cancer accrued to this study
Time Frame: Baseline through End of Study
|
Baseline through End of Study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gabriela Chiorean, MD, Indiana University
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
May 1, 2005
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
August 7, 2008
First Submitted That Met QC Criteria
August 7, 2008
First Posted (Estimate)
August 11, 2008
Study Record Updates
Last Update Posted (Estimate)
September 11, 2014
Last Update Submitted That Met QC Criteria
September 10, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0412-21/ IUCRO-0101
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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