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Trial record 8 of 128 for:    Adenoid Cystic Carcinoma

Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

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ClinicalTrials.gov Identifier: NCT01558661
Recruitment Status : Completed
First Posted : March 20, 2012
Results First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Collaborators:
National Comprehensive Cancer Network
Pfizer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE March 16, 2012
First Posted Date  ICMJE March 20, 2012
Results First Submitted Date  ICMJE July 17, 2017
Results First Posted Date  ICMJE November 28, 2017
Last Update Posted Date November 28, 2017
Study Start Date  ICMJE March 2012
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
Overall Response Rate [ Time Frame: 2 years ]
Best overall response rate documented by RECIST v1.1 criteria of patients with progressive, recurrent/metastatic ACC treated with axitinib. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
Overall Response Rate [ Time Frame: 2 years ]
Best overall response rate documented by RECIST v1.1 criteria of patients with progressive, recurrent/metastatic ACC treated with axitinib.
Change History Complete list of historical versions of study NCT01558661 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
  • Median Progression-free Survival (PFS). [ Time Frame: 2 years ]
    Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"
  • MYB Immunohistochemistry (IHC) [ Time Frame: 2 years ]
  • Number of Participants With Next Generation Sequencing (NGS) [ Time Frame: 2 years ]
    Next generation sequencing the t(6;9) translocation (MYBNFIB gene product) status will be analyzed by Fluorescent In-Situ Hybridization (FISH) assay and correlated to clinical response. The number of participants with NGS will be recorded.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
  • median progression-free survival (PFS). [ Time Frame: 2 years ]
    Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
  • ACC tumor responses [ Time Frame: 2 years ]
    To evaluate the hypothesis that ACC tumor responses to axitinib are correlated to baseline expression of PDGFR and/or c-myb driven expression of c-kit and VEGFR. Levels of c-kit, VEGF, VEGFR-2, PDGF, PDGFRα/β, and c-myb in archival tumor tissue will be quantified by immunohistochemistry (IHC) and their association with objective response to axitinib will be investigated using the non-parametric Wilcoxon signed-rank test.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
Official Title  ICMJE A Phase II Study of Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
Brief Summary

The purpose of this study is to find out what effects, good and/or bad, a new treatment called axitinib has on the patient and adenoid cystic carcinoma. This type of cancer study is called a phase II study.

Axitinib is an oral medication that can interfere with cancer cell growth and reduce the growth of blood vessels around tumors. This study will help find out if axitinib is a useful drug for treating patients with adenoid cystic carcinomas. Axitinib is an experimental drug that has not yet been approved by the Food and Drug Administration for use in adenoid cystic carcinoma.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenoid Cystic Carcinoma
Intervention  ICMJE Drug: AG-013736 (AXITINIB)
All eligible patients will receive a starting axitinib dose of 5 mg twice daily (BID) taken orally in 4-week (28-day) cycles. Patients who tolerate axitinib with no adverse events related to study drug above CTCAE v. 4.0 Grade 2 for a consecutive 2-week period may have their dose increased by one dose level according to the discretion of the treating physician (NOT allowed for patients with blood pressure (BP) > 150/90 mm Hg or who are receiving antihypertensive medication). This dose escalation is not mandatory. RECIST v1.1 tumor assessments will be made at baseline (CT or MRI) and then approximately every 2 cycles (or every 8 weeks (+/- 1 week)). After 10 months, imaging will be done every 3 cycles (or every 12 weeks (+/- 1 week)). Patients may remain on study until progression of disease or unacceptable toxicity.
Study Arms  ICMJE Experimental: AG-013736 (AXITINIB)
This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
Intervention: Drug: AG-013736 (AXITINIB)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2016)
33
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2012)
32
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have MSKCC pathologically confirmed adenoid cystic carcinoma. Cancers arising from non-salivary gland primary sites are allowed.
  • Patients must have locally advanced and/or recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy.
  • At least 2 weeks must have elapsed since the end of prior systemic treatment (4 weeks for bevacizumab- containing regimens), radiotherapy, or surgical procedure with resolution of all treatment-related toxicity to NCI CTCAE Version 4.0 grade ≤1 (or tolerable grade 2) or back to baseline except for alopecia or hypothyroidism.
  • Patients must have RECIST v1.1 measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as > or = to 20 mm with conventional techniques or as > or = to 10 mm with spiral CT scan.
  • Patients must have documentation of a new or progressive lesion on a radiologic imaging study performed within 6 months prior to study enrollment (progression of disease over any interval is allowed) and/or new/worsening disease related symptoms. Note: This assessment will be performed by the treating investigator. Evidence of progression by RECIST criteria is not required.
  • Patients must have archival tissue from the primary tumor or metastases available for correlative studies. Either a paraffin block or twenty unstained slides containing 5μm sections are acceptable. If twenty slides are not available, a lesser amount may be acceptable after discussion with the study Principal Investigator, Dr. Alan L. Ho.
  • Male or female, age > or = to 18 years.
  • ECOG performance status < or = to 2 (Karnofsky > or = to 60%, see Appendix A).
  • Life expectancy of ≥ 12 weeks.

Adequate organ function as defined by the following criteria:

  • absolute neutrophil count (ANC) > 1000 cells/mm3
  • platelets > or = to 75,000 cells/mm3
  • Hemoglobin > or = to 9.0 g/dL
  • AST and ALT < or = to 2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT < 5.0 x ULN
  • Total bilirubin < or = to 1.5 x ULN
  • Serum creatinine < or = to 1.5 x ULN or calculated creatinine clearance > or = to 60 ml/min
  • Urinary protein < 2+ by urine dipstick. If dipstick is > or = to 2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is < 2 g per 24 hours.
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after discontinuing study treatment.

Exclusion Criteria:

  • Major surgery < 2 weeks or radiation therapy < 2 weeks of starting the study treatment.
  • Gastrointestinal abnormalities including:

    • inability to take oral medication;
    • malabsorption syndromes.
  • Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine)
  • Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (i.e., carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort)
  • Requirement for anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
  • Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
  • A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
  • Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
  • Female patients who are pregnant or lactating.
  • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01558661
Other Study ID Numbers  ICMJE 12-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • National Comprehensive Cancer Network
  • Pfizer
Investigators  ICMJE
Principal Investigator: Alan L. Ho, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP