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Trial record 6 of 7 for:    sunitinib | Recruiting, Not yet recruiting Studies | Neuroendocrine Tumors

First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma (FIRSTMAPPP)

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ClinicalTrials.gov Identifier: NCT01371201
Recruitment Status : Recruiting
First Posted : June 10, 2011
Last Update Posted : January 26, 2017
Sponsor:
Collaborators:
National Cancer Institute, France
ENSAT-CANCER European Network for the Study of Adrenal Tumours
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE June 9, 2011
First Posted Date  ICMJE June 10, 2011
Last Update Posted Date January 26, 2017
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2011)
Progression-free survival at 12 months [ Time Frame: 12 months ]
Progression will be assessed by RECIST 1.1 performed every 3 months (centralized imaging)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
  • Objective Response Rates (ORR) [ Time Frame: 12 months ]
  • Duration of response (DR) [ Time Frame: 12 months ]
  • Overall Time to Progression (TTP) [ Time Frame: 12 months ]
  • Overall survival (OS) [ Time Frame: 12 months ]
  • Number of Adverse Events assessed using NCI -CTC V4 criteria [ Time Frame: 12 months ]
    Number and description of adverse events and number of patients with adverse events according to NCI -CTC V4 criteria
  • Number of patients with cardiovascular toxicity tolerance assessed by specific organisation for blood pressure monitoring [ Time Frame: 12 months ]
    Cardiovascular tolerance will be assessed by specific organisation for blood pressure monitoring
  • Bone Pain evaluation on the Visual Analog Scale [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2011)
  • Objective Response Rates (ORR) [ Time Frame: 12 months ]
  • Duration of response (DR) [ Time Frame: 12 months ]
  • Overall Time to Progression (TTP) [ Time Frame: 12 months ]
  • Overall survival (OS) [ Time Frame: 12 months ]
  • Number of Adverse Events assessed using NCI -CTC V4 criteria
    Number and description of adverse events and number of patients with adverse events according to NCI -CTC V4 criteria
  • Number of patients with cardiovascular toxicity tolerance assessed by specific organisation for blood pressure monitoring
    Cardiovascular tolerance will be assessed by specific organisation for blood pressure monitoring
  • Bone Pain evaluation on the Visual Analog Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma
Official Title  ICMJE First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma (PPGL)
Brief Summary The FIRSTMAPPP study is a randomized, double-blind, phase II, international, multicenter study which aims to determine the efficacy of Sunitinib on the progression-free survival at 12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous dosing).
Detailed Description

PRIMARY OBJECTIVE:

To determine the efficacy of Sunitinib on the progression-free survival at 12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous dosing).

SECONDARY OBJECTIVES:

  • To determine overall survival and progression free survival.
  • To determine time to progression.
  • To determine objective response rate at one year.
  • To determine time to and duration of tumor response.
  • To assess safety profile including a dedicated cardiovascular management (home-blood pressure monitoring, ECG and echocardiography).

EXPLORATORY OBJECTIVES:

-Identification of predictors of response as well as surrogate markers of overall survival is anticipated

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Malignant Progressive Pheochromocytoma and Paraganglioma (PPGL)
Intervention  ICMJE
  • Drug: Sunitinib
    sunitinib 37.5 mg per day
    Other Name: Sutent
  • Drug: Placebo
    Placebo 37.5 mg per day
Study Arms  ICMJE
  • Experimental: Sunitinib
    sunitinib 37.5 mg per day
    Intervention: Drug: Sunitinib
  • Placebo Comparator: Placebo
    Placebo 37.5 mg per day
    Intervention: Drug: Placebo
Publications * Fankhauser M, Bechmann N, Lauseker M, Goncalves J, Favier J, Klink B, William D, Gieldon L, Maurer J, Spöttl G, Rank P, Knösel T, Orth M, Ziegler CG, Aristizabal Prada ET, Rubinstein G, Fassnacht M, Spitzweg C, Grossman AB, Pacak K, Beuschlein F, Bornstein SR, Eisenhofer G, Auernhammer CJ, Reincke M, Nölting S. Synergistic Highly Potent Targeted Drug Combinations in Different Pheochromocytoma Models Including Human Tumor Cultures. Endocrinology. 2019 Nov 1;160(11):2600-2617. doi: 10.1210/en.2019-00410.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 9, 2011)
74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of malignant PPGL, based on imaging or biopsy evidence of metastases in liver, bones, lungs and or lymph nodes, combined with at least one of two further confirmatory diagnoses: 1. diagnosis of PPGL from histopathological review of resected or biopsied tissue performed by a skilled pathologist (centralized review will be performed in all cases either before enrolment in case of any doubt or during the study); or 2. in patients where tumor tissue is unavailable for formal pathological review, from combined biochemical and functional imaging evidence of PPGL (e.g., MIBG scintigraphy combined with consistently and highly elevated plasma or urine levels of metanephrines).
  • Metastatic disease not amenable to surgical resection
  • Pre-treated or not
  • Whatever the genetic status (sporadic or inherited)
  • Evaluable disease according to RECIST 1.1 criteria
  • Progressing disease within 18 months at imaging prior to randomization according to RECIST. The recent scan indicating progression may be used as the screening scan if within 28 days of randomization
  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months as prognosticated by the physician
  • Age ≥18 years, no superior limit
  • Adequate bone marrow reserve (Hb > 8, neutrophils ≥ 1500/mm³ and platelets ≥80.000/mm³)
  • Effective contraception in pre-menopausal female and male patients
  • Negative pregnancy test
  • Patient´s signed written informed consent
  • Ability to comply with the protocol procedures
  • Ability to take oral medication

Exclusion Criteria:

  • Large or small cell-poorly differentiated neuroendocrine carcinoma according to WHO 2000 classification
  • History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
  • Severe renal (GFR <30ml/mn or nephrotic syndrome) or hepatic insufficiency (ALT / AST > 2.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN)
  • Patients with cardiac events within the previous 12 months, such as myocardial infarction (including severe/unstable angina pectoris), coronary/peripheral artery bypass graft, revascularization procedure symptomatic congestive heart failure (CHF, ejection fraction <45%), ), uncontrolled cardiac arrhythmia, clinically significant bradycardia, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
  • Hypertension that cannot be controlled despite medications (>=160/95 mmHg despite optimal medical therapy)
  • Abnormal cardiac function with 12 lead ECG. Ongoing cardiac dysrhythmias of NCI CTC grade >=2, atrial fibrillation of any grade, or prolongation of the QTc interval to >470 msec for males or >480 msec for females.
  • Brain metastases (exception if stable and asymptomatic for more than 3 months)
  • Pregnancy or breast feeding
  • Previous treatment with the drug under study. Prior systemic treatment with any tyrosine kinase inhibitors or anti VEGF angiogenic inhibitors.
  • Current treatment with another investigational drug.
  • Treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days, respectively prior to study drug administration
  • Concomitant treatment with therapeutic doses of anticoagulants. Low dose warfarin (Coumadin) up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed as well as heparin-based anticoagulation
  • Prior treatments with chemotherapy, immunotherapy, somatostatine analog therapy drug , thoracic radiotherapy within 4 weeks prior to inclusion
  • Major surgery for any cause or local radiotherapy within one month prior to visit 1
  • Liver embolisation therapy within the last 3 months prior visit 1 except if progression is demonstrated and embolised lesion not used as targets
  • Unrecovered toxicity from any kind of therapy
  • Active or suspected acute or chronic uncontrolled disease that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, 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
Listed Location Countries  ICMJE France,   Germany,   Italy,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01371201
Other Study ID Numbers  ICMJE IGR2010/1715
2010-024621-20 ( EudraCT Number )
MSI/A110356-31 ( Other Identifier: AFSSAPS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Collaborators  ICMJE
  • National Cancer Institute, France
  • ENSAT-CANCER European Network for the Study of Adrenal Tumours
Investigators  ICMJE
Principal Investigator: Eric Baudin, MD Gustave Roussy, Cancer Campus, Grand Paris
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date January 2017

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