- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00528619
A Study To Find The Best Dose Of SU011248 When Given With Pemetrexed, Pemetrexed And Cisplatin Or Pemetrexed And Carboplatin In Patients With Advanced Solid Tumors
April 7, 2011 updated by: Pfizer
Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies
This study will assess the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin in patients with advanced solid tumors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
96
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
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- Pfizer Investigational Site
-
-
Quebec
-
Montreal, Quebec, Canada, H2L 4M1
- Pfizer Investigational Site
-
-
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Pfizer Investigational Site
-
-
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:
- Patients with a diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists.
- Patient has a good performance status (ECOG 0 or 1).
Exclusion Criteria:
- Prior treatment with either pemetrexed or SU011248.
- Coughing up blood within 4 weeks before starting study treatment (small amounts okay).
- Hypertension that cannot be controlled by medications.
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
|
Dose finding study using Sunitinib daily by oral capsule in a continuous regimen or administered for 2 weeks out of every 3 weeks, with pemetrexed every 3 weeks or also with cisplatin 75 mg/m2 or carboplatin AUC=5 mg*min/mL until progression or unacceptable toxicity.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin.
Time Frame: From screening until at least 28 days beyond discontinuation of study treatment
|
From screening until at least 28 days beyond discontinuation of study treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the plasma pharmacokinetics of SU011248 and its metabolite, SU012662 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin when these drugs are co-administered.
Time Frame: From screening until disease progression or discontinuation of the study
|
From screening until disease progression or discontinuation of the study
|
To preliminarily assess the antitumor activity of SU011248 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin in patients with non-small cell lung cancer or advanced unresectable mesothelioma.
Time Frame: From screening until disease progression or discontinuation of the study
|
From screening until disease progression or discontinuation of the study
|
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
November 1, 2006
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
September 10, 2007
First Submitted That Met QC Criteria
September 10, 2007
First Posted (Estimate)
September 12, 2007
Study Record Updates
Last Update Posted (Estimate)
April 8, 2011
Last Update Submitted That Met QC Criteria
April 7, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Folic Acid Antagonists
- Carboplatin
- Sunitinib
- Pemetrexed
Other Study ID Numbers
- A6181084
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.
Clinical Trials on Neoplasms
-
GlaxoSmithKlineCompleted
-
Amphia HospitalRecruitingColonic Neoplasms MalignantNetherlands
-
Marquette General Health SystemUpper Michigan Brain Tumor CenterWithdrawnGlioma | MeningiomaUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedBrain Stem Neoplasms, Primary | Neoplasms, Brain StemUnited States
-
GlaxoSmithKlineRecruitingNeoplasms, RectalUnited States, France, Italy, Japan, Spain, United Kingdom, Germany, Korea, Republic of, Canada, Netherlands
-
Russian Society of Colorectal SurgeonsRecruitingNeoplasms,ColorectalRussian Federation
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
Novartis PharmaceuticalsBayerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic NeoplasmsUnited States, Germany, Belgium, Canada, Spain, United Kingdom, Taiwan, France, Switzerland, Sweden, Portugal, New Zealand, Italy, Slovakia, Australia, Austria, Brazil, Hong Kong
-
University of Michigan Rogel Cancer CenterNational Cancer Institute (NCI); Department of Health and Human Services; Early... and other collaboratorsRecruitingColonic NeoplasmsUnited States, Canada, Australia
Clinical Trials on Sunitinib, Pemetrexed, Cisplatin, Carboplatin
-
BeiGeneCompletedNon-Small Cell Lung CancerChina
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Not yet recruitingAdvanced or Metastatic Non-squamous Non-small-cell Lung Cancer
-
AstraZenecaParexelActive, not recruitingNon-small Cell Lung CancerItaly, Spain, United States, China, Germany, Israel
-
AstraZenecaActive, not recruitingNon Small Cell Lung Cancer NSCLCPoland, United States, Taiwan, Thailand, Vietnam, Korea, Republic of, United Kingdom, Brazil, Hungary, Japan, Mexico, Peru, Russian Federation, China, Germany, South Africa, Ukraine, Bulgaria, Hong Kong
-
PfizerCompletedNSCLC (Non-small Cell Lung Cancer)Hong Kong, China, Taiwan, Malaysia, Thailand
-
Innate PharmaRecruitingNon Small Cell Lung CancerFrance, United States, Greece, Hungary, Poland
-
Sichuan UniversityChia Tai Tianqing Pharmaceutical Group Co., Ltd.CompletedNon-squamous Non-small-cell Lung Cancer | AnlotinibChina
-
Li Zhang, MDRecruitingCarcinoma, Non-Small-Cell LungChina
-
Innovent Biologics (Suzhou) Co. Ltd.Not yet recruitingNon-squamous Non-small-cell Lung CancerChina
-
AstraZenecaActive, not recruitingNon Small Cell Lung Carcinoma NSCLCPoland, Taiwan, Thailand, Vietnam, United States, Korea, Republic of, Hungary, Russian Federation, Turkey, China, Australia, Netherlands