A Study of Axitinib in Advanced Carcinoid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01435122|
Recruitment Status : Active, not recruiting
First Posted : September 15, 2011
Results First Posted : May 25, 2017
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoid Tumor||Drug: Axitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Axitinib in Advanced Carcinoid Tumors|
|Actual Study Start Date :||October 25, 2011|
|Primary Completion Date :||January 4, 2017|
|Estimated Study Completion Date :||January 2019|
Experimental: Axitinib Administration
The investigational drug used in this study is axitinib, and is available as tablets.
You will take the tablet orally with food. Doses should be taken around 12 hours apart continuously, without scheduled breaks. If you vomit anytime after taking a dose do not take another tablet to "make up the dose" but instead continue taking your next dose as planned.
Any missed dose may be taken late (up to 3 hours before the next scheduled dose); otherwise it should be skipped. If doses are missed or vomited, please keep track of this and report at your next visit.
Axitinib Administration as outlined in Arm description
- Rate of Progression Free Survival (PFS) [ Time Frame: 12 Months ]Progression-free survival rate at 12 months. PFS: determined as the time from administration of the initial dose of axitinib until objective tumor progression using Response Evaluation Criteria In Solid Tumors (RECIST), or death. Progressive Disease (PD) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- Median Progression Free Survival [ Time Frame: Up to 36 Months ]Post follow-up progression free survival at time of analysis.
- Tumor Response Rate [ Time Frame: 12 Months ]Tumor response rate using RECIST. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- 24 Month Overall Survival (OS) Rate [ Time Frame: 24 months ]Overall survival by Kaplan Meier, determined from the time of drug administration to death from any cause. The effect of an intervention is assessed by measuring the number of subjects survived or saved after that intervention over a period of time. The time starting from a defined point to the occurrence of a given event, for example death is called as survival time and the analysis of group data as survival analysis.
- Time to Treatment Failure [ Time Frame: 12 Months ]Time to Treatment Failure: Time from administration of the initial dose of axitinib until study discontinuation for any reason (e.g., disease progression, toxicity, death, withdrawal of consent).
- Occurrence of Possibly Related Adverse Events (AEs) [ Time Frame: 12 Months ]Grade 2 through 4 toxicities considered at least possibly related to treatment. Percentage of participants affected per category. Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology and blood chemistry parameters and regular physical examinations. Adverse events will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the National Institute of Health/National Cancer Institute (NIH/NCI) Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435122
|United States, California|
|University of California San Francisco (UCSF)|
|San Francisco, California, United States, 94115|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Jonathan Strosberg, M.D.||H. Lee Moffitt Cancer Center and Research Institute|