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History of Changes for Study: NCT02389244
A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas (REGOBONE)
Latest version (submitted April 1, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 16, 2015 None (earliest Version on record)
2 June 21, 2016 Contacts/Locations, Outcome Measures, Study Status, Arms and Interventions, Study Description, IPDSharing, Eligibility, Study Design and Conditions
3 August 14, 2018 Contacts/Locations, Study Status, Eligibility and Arms and Interventions
4 September 24, 2019 Study Status, Eligibility and Arms and Interventions
5 October 14, 2019 Study Status
6 November 4, 2020 Outcome Measures, Arms and Interventions, Study Description, Study Status, Contacts/Locations, Eligibility, Conditions and Study Identification
7 March 30, 2021 Contacts/Locations, Oversight, Study Status and Eligibility
8 April 1, 2022 Study Status
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Study NCT02389244
Submitted Date:  March 16, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: UC-0150/1309
Brief Title: A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas (REGOBONE)
Official Title: A Randomized Phase II, Placebo-controlled, Multicenter Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2015
Overall Status: Recruiting
Study Start: September 2014
Primary Completion: September 2016 [Anticipated]
Study Completion: March 2019 [Anticipated]
First Submitted: February 9, 2015
First Submitted that
Met QC Criteria:
March 16, 2015
First Posted: March 17, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 16, 2015
Last Update Posted: March 17, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: UNICANCER
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

INDICATION:

Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone, intermediate or high-grade chondrosarcomas.

Detailed Description:

METHODOLOGY:

Randomized, placebo-controlled, multicentric, phase II study -This is a double-blind placebo-controlled trial, with 3 strata: Strata A: Osteosarcoma Strata B: Ewing sarcoma Strata C: Chondrosarcoma Each stratum will involve a total of 36 patients (24 Regorafenib + 12 placebo).

Approximately 108 patients who meet the eligibility criteria will be randomly assigned in a 2:

1 ratio to the following treatment groups :

The Arm A:

Regorafenib (160 mg/d) once daily for the 3 weeks on / 1 week off plus Best Supportive Care (BSC) until progression (according to RECIST 1.1), intolerance or withdrawal of consent .

Patients receiving regorafenib who experience disease progression and for whom in the investigator opinion, treatment with regorafenib is providing clinical benefit, may continue the treatment following consultation with the study coordinator and the sponsor.

The Arm B:

Placebo plus BCS until progression (according to RECIST V1.1) intolerance or withdrawal of consent. Patients who have received placebo will receiveopen-label regorafenib after objective tumor progression.

Patients will be stratified at randomization according to histology .

Open or close this module Conditions
Conditions: Ewing Sarcomas
Chondrosarcomas
Osteosarcomas
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 108 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Regorafenib
160 mg/d once daily for the 3 weeks on / 1 week off plus Best Supportive Care (BSC) until progression (according to RECIST 1.1), intolerance or withdrawal of consent .
Drug: Regorafenib
4 tablets once daily until progression or innaceptable toxicity
Other Names:
  • Stivarga
Placebo Comparator: placebo
Placebo plus BCS until progression (according to RECIST V1.1) intolerance or withdrawal of consent. Patients who have received placebo will receiveopen-label regorafenib after objective tumor progression.
Drug: Placebo
4 tablets once daily and switch to regorafenib after confirmed progression
Other Names:
  • Placebo tablet
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The primary efficacy endpoint is PFS [defined using RECIST 1.1] after central radiological review
[ Time Frame: expected average duration of 3 months ]

from the date of randomization until the date of radiological progression or death whatever the cause
Secondary Outcome Measures:
1. Objective response rate
[ Time Frame: 6 months ]

2. Disease control rate at 6 months
[ Time Frame: 6 months ]

from the date of randomization until the date of death due to any cause
3. Overall survival
[ Time Frame: the time from the date of randomization until the date of death due to any cause (up to 6 months) ]

4. Duration of response
[ Time Frame: expected average duration of 6 months ]

objective response of CR or PR, whichever is noted earlier, to first disease progression or death before progression
5. Progression-free rate at 3 and 6 months
[ Time Frame: at 3 and 6 months ]

6. Time to progression
[ Time Frame: from date of randomization until the date of first observation of progression (up to 6 months) ]

7. Growth Modulation Index defined as ratio of time to PD under regorafenib to TTP under previous treatment
[ Time Frame: time to PD under regorafenib to TTP under previous treatment (up to 6 months) ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Patients must have histologically confirmed diagnosis of bone sarcoma (osteosarcoma, Ewing sarcoma of bone, chondrosarcoma) ;
  2. Patients with confirmed disease progression at study entry.
  3. Metastatic disease not amenable to surgical resection or radiation with curative intent;
  4. Patients must have measurable disease ;
  5. Prior treatment :

    at least one, but no more than two prior chemotherapy regimen for metastatic disease. At least 4 weeks since last chemotherapy (6 weeks in case of nitrosoureas and mitomycin C), immunotherapy or any other pharmacological treatment and/or radiotherapy;

  6. Age ≥ 18 years;
  7. Life expectancy of greater than 3 months;
  8. ECOG performance status < 2 (Karnofsky ≥ 60%);
  9. Patients must have adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation : normal organ function as defined below :
    • Absolute neutrophil count ≥ 1.5 Giga/L
    • Platelets ≥ 100 Giga/L
    • Hemoglobin≥ 9 g/dL
    • Serum creatinin ≤ 1.5 x ULN
    • Glomerular filtration rate (GFR) ≥30 ml/min/1.73m2 according to the modified Diet in Renal Disease (MDRD) abbreviated formula
    • AST and ALT ≤2.5 x ULN
    • Bilirubin ≤1.5 X ULN
    • Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in patient with liver involvement of their cancer). If Alkaline phosphatase > 2.5 ULN, hepatic isoenzymes 5-nucleotidase or GGT tests must be performed; hepatic isoenzymes 5-nucleotidase must be within the normal range and/or GGT < 1.5 x ULN
    • lipase ≤1.5 x ULN.
    • Spot urine must not show 1+ or more protein in urine or the patient will require a repeat urine analysis. If repeat urinalysis shows 1+ protein or more, a 24-hour urine collection will be required and must show total protein excretion <1000 mg/24 hours
  10. INR/PTT ≤1.5 x ULN;

Exclusion Criteria:

  1. Prior treatment with any VEGFR inhibitor;
  2. Soft tissue sarcoma;
  3. Other cancer (different histology) within 5 years prior to randomization;
  4. Major surgical procedure, open biopsy, significant trauma, within the last 28 days before randomization;
  5. Cardiovascular dysfunction:
    • Left ventricular ejection fraction (LVEF) < 50%
    • Congestive heart failure (New York Heart Association [NYAH]) ≥ 2
    • Myocardial infarction <6 months before study
    • Cardiac arrhythmias requiring therapy
    • Uncontrolled hypertension
    • Unstable angina or new-onset angina
  6. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the last 6 months before randomization;
  7. Severe hepatic impairment (Child-Pugh C);
  8. Ongoing infection > Grade 2 according to NCI-CTCAE v4.0;
  9. Known history of human immunodeficiency virus (HIV) infection;
  10. Known history of chronic hepatitis B or C;
  11. Difficulties with swallowing study tablets;
Open or close this module Contacts/Locations
Central Contact Person: Buffard Karine, Pharm D
Telephone: 33 (0)144230404
Email: k-buffard@unicancer.fr
Study Officials: Duffaud Florence, Pr
Principal Investigator
La Timone University Hospital
Locations: France
Hopital Jean Monjoz
[Not yet recruiting]
Besancon, France, 25030
Contact:Principal Investigator: Kalbacher Elsa
Centre Francois Baclesse
[Active, not recruiting]
Caen, France, 14176
Centre Oscar Lambret
[Recruiting]
Lille, France, 59020
Contact:Principal Investigator: Penel Nicolas
Centre Léon Berard
[Recruiting]
Lyon, France, 69373
Contact:Principal Investigator: Blay Jean Yves, Pr
La Timone University Hospital
[Recruiting]
Marseille, France, 13385
Contact:Principal Investigator: Duffaud Florence, Pr
Centre Antoine Lacassagne
[Active, not recruiting]
Nice, France, 06189
Institut Curie
[Recruiting]
Paris, France
Contact:Principal Investigator: Piperno-Neumann Sophie
Institut de cancerologie de l'ouest site Rene Gauducheau
[Recruiting]
Saint Herblain, France, 44805
Contact:Principal Investigator: Bompas Emmanuelle
Institut Claudius Regaud
[Recruiting]
Toulouse, France, 31052
Contact:Principal Investigator: Chevreau Christine
Institut de cancerologie de lorraine alexis Vautrin
[Active, not recruiting]
Vandoeuvre les Nancy, France, 54519
Gustave Roussy
[Recruiting]
Villejuif, France, 94800
Contact:Principal Investigator: Domont Julien
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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