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Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma (PACSA-ORL02)

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ClinicalTrials.gov Identifier: NCT02393820
Recruitment Status : Completed
First Posted : March 19, 2015
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Tracking Information
First Submitted Date  ICMJE March 13, 2015
First Posted Date  ICMJE March 19, 2015
Last Update Posted Date October 29, 2019
Actual Study Start Date  ICMJE August 26, 2013
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
progression free survival [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
Official Title  ICMJE Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
Brief Summary Open-label, multicenter, single arm phase II study, set up in collaboration with the "Réseau d'Expertise Français sur les Cancers ORL Rares" (REFCOR), evaluating the activity and safety of single agent pazopanib in recurrent or metastatic tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).
Detailed Description

In the non-ACC SGCHN population, assessment of the activity of pazopanib is exploratory without a predetermined study design, with up to 20 patients. A planned interim analysis of acute toxicities was conducted 3 months after the 14th non-ACC inclusion.

ACC As the endpoint will be evaluated at 6 months after treatment start, a one-stage phase II study design was chosen. The unacceptable 6-month rate of progression free survival is 20% and the promising 6-month rate of progression free survival is 40%.

43 patients are to be treated. If ≤12 patients alive without progression at 6 months will be observed, the drug will be declared ineffective.

If ≥13 patients alive without progression at 6 months will be observed, the drug will be declared promising.

The α error rate (accepting a poor treatment) is 0.07 and the β error rate (rejecting a promising treatment) is 0.07.

Analysis of results will be separated between non ACC and ACC.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Salivary Gland Carcinoma
Intervention  ICMJE Drug: pazopanib
treatment will be given until progression or unacceptable toxicity .
Other Name: Votrient
Study Arms  ICMJE Experimental: pazopanib
Pazopanib per os, 800mg daily until progression
Intervention: Drug: pazopanib
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: June 17, 2016)
72
Original Actual Enrollment  ICMJE
 (submitted: March 18, 2015)
71
Actual Study Completion Date  ICMJE October 2019
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed diagnosis of recurrent and/or metastatic salivary glands (including ACC and non ACC).
  • Progressive disease within 6 months before inclusion as assessed by CT and/or MRI using at least two measurements (RECIST v1.0) with at least one measurable target lesion >10 mm.
  • Recurrent and/or metastatic salivary glands carcinoma failing locoregional therapy, without possibility of curative treatment.
  • Patients may have had unlimited prior therapy but must have had at least 4 weeks between any chemotherapy, radiotherapy, surgery and study enrollment.
  • Tumoral tissue must be provided for subsequent histological review and biomarker analysis.
  • Euthyroid patient.
  • Hepatic, renal, cardiac and hematology normal functions.
  • Ability to take oral medication.

Exclusion Criteria:

  • Non salivary gland carcinoma (lachrymal gland tumor is excluded).
  • Known or symptomatic cerebral metastasis.
  • Patients treated with strong inhibitor or inductor of CYP3A4 within 14 days before inclusion.
  • Presence of uncontrolled infection.
  • Diagnosis of any previous malignancy within the last 5 years, except for completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma.
  • Stable disease.
  • Corrected QT interval (QTc) >480 msecs using Bazett's formula.
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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02393820
Other Study ID Numbers  ICMJE UC-0130/1205
2012-004408-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual Participant Data (IPD) will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joel Mr Guigay, Pr Centre Lacassagne Nice
PRS Account UNICANCER
Verification Date October 2019

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