A Phase 1b Study Of Axitinib In Combination With Crizotinib In Patients With Advanced Solid Tumors
NCT ID: NCT01999972
Last Updated: 2020-09-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2014-02-26
2019-09-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Of Crizotinib Plus VEGF Inhibitor Combinations In Patients With Advanced Solid Tumors.
NCT01441388
Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials
NCT00828919
Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors
NCT00447005
A Study In Patients With Advanced Solid Tumor
NCT00726752
Pharmacodynamic Study of Axitinib in Patients With Advanced Solid Malignancies
NCT00859118
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Axitinib in combination with crizotinib, escalation phase
Dose Escalation Advanced solid tumor that is resistant to standard therapy or for which no standard therapy is available
axitinib
Axitinib: tablets, dosage range 2 - 5 mg, given orally twice daily on a continuous dosing schedule in 28 days cycles.
crizotinib
Crizotinib: capsules, dosage range 200-250 mg, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle.
Expansion Phase Cohort 1
Dose Expansion, Cohort 1: axitinib in combination with crizotinib Advanced renal cell cancer \[RCC\] with no prior systemic therapy
axitinib
Axitinib: tablets, dosage be defined based on Arm 1 results, given orally twice daily on a continuous dosing schedule in 28 days cycles.
crizotinib
Crizotinib: capsules, dosage be defined based on Arm 1 results, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle.
Expansion Phase Cohort 2
Dose Expansion, Cohort 2: axitinib in combination with crizotinib Advanced renal cell cancer with at least one but no more than two prior systemic treatment regimens directed at advanced RCC
axitinib
Axitinib: tablets, dosage be defined based on Arm 1 results, given orally twice daily on a continuous dosing schedule in 28 days cycles.
crizotinib
Crizotinib: capsules, dosage be defined based on Arm 1 results, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
axitinib
Axitinib: tablets, dosage range 2 - 5 mg, given orally twice daily on a continuous dosing schedule in 28 days cycles.
crizotinib
Crizotinib: capsules, dosage range 200-250 mg, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle.
axitinib
Axitinib: tablets, dosage be defined based on Arm 1 results, given orally twice daily on a continuous dosing schedule in 28 days cycles.
crizotinib
Crizotinib: capsules, dosage be defined based on Arm 1 results, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle.
axitinib
Axitinib: tablets, dosage be defined based on Arm 1 results, given orally twice daily on a continuous dosing schedule in 28 days cycles.
crizotinib
Crizotinib: capsules, dosage be defined based on Arm 1 results, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis - Dose Expansion Phase: Histologically or cytologically confirmed advanced RCC with a component of clear cell subtype
* Dose Expansion Phase: at least one measureable lesion as defined by RECIST \[Response Evaluation Criterion in Solid Tumors\] version 1.1.
* ECOG \[Eastern Cooperative Oncology Group\] Performance Status 0 or 1.
Exclusion Criteria
* History of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
* Dose Expansion Phase only: diagnosis of any other malignancy within 2 years prior to registration.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Chicago Medical Center
Chicago, Illinois, United States
Investigational Drug Services IUHSCC
Indianapolis, Indiana, United States
IU Health University Hospital
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Wayne State University, Dept. of Oncology
Detroit, Michigan, United States
University of Minnesota Health Clinics and Surgery Center
Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview IDS Pharmacy
Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States
University of Minnesota Physicians Masonic Cancer Center
Minneapolis, Minnesota, United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, Ohio, United States
Huntsman Cancer Hospital
Salt Lake City, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
John A Moran Eye Center
Salt Lake City, Utah, United States
University Station Ophthalmology Clinic
Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
St Bartholomew's Hospital - Barts Health NHS Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Michaelson MD, Gupta S, Agarwal N, Szmulewitz R, Powles T, Pili R, Bruce JY, Vaishampayan U, Larkin J, Rosbrook B, Wang E, Murphy D, Wang P, Lechuga MJ, Valota O, Shepard DR. A Phase Ib Study of Axitinib in Combination with Crizotinib in Patients with Metastatic Renal Cell Cancer or Other Advanced Solid Tumors. Oncologist. 2019 Sep;24(9):1151-e817. doi: 10.1634/theoncologist.2018-0749. Epub 2019 Jun 6.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-001724-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A4061068
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.