Health TrialsbyHealthPanel

Efficacy of Regorafenib Combined With Best Supportive Care as Maintenance Treatment in High Grade Bone Sarcomas Patients

ConditionsBone SarcomaOsteosarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorCentre Leon Berard

About this trial

This is a multicenter phase II study concerning patients with high-grade bone sarcoma (HGBS) without complete remission after standard treatment at diagnosis or at relapse.

Patients will be treated with regorafenib + best supportive care (BSC) for a maximum of 12 months as maintenance therapy after standard line therapy completion.

Progression free rate (PFR) data will be collected and analysed for all included patients to evaluate if regorafenib + BSC can be considered as an interesting treatment for further investigations in this indication.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Left ventricular ejection fraction (LVEF) < 50%,

Congestive heart failure ≥ New York Heart Association (NYHA) class 2,

Myocardial infarction < 6 months prior to first study drug administration,

Cardiac arrhythmias requiring therapy (beta blockers or digoxin are permitted),

Trial design

Design model

Single group

Treatments tested in this trial

  • Treatment by regorafenib and best supportive care

    Drug

    Treatment for 13 cycles (12 months) maximum. During each cycle : * patients ≥ 16 years old and patients \<16 old with Body Surface Area (BSA) ≥ 1,70 m2 will take 3 tablets, once a day, corresponding to a total of 120 mg Regorafenib, during 21 days, followed by 7 days without treatment. * patients \< 16 years old with a 1,30 m2 ≤ BSA ≥ 1,70 m2 will take 2 tablets, once a day, corresponding to a total of 80 mg Regorafenib, during 21 days, followed by 7 days without treatment

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Regorafenib and best supportive careExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Rate at 4 months (4m-PFR)

The Progression-Free Rate at 4 months (4m-PFR) will be defined as the proportion of patients with a complete response, a partial response or stable disease, confirmed on tumour assessments according to the RECIST V1.1 at 4 months (16 weeks) after the date of regorafenib + BSC treatment initiation. Patients with a non-progressive disease at 16 ± 2 weeks after the date of regorafenib + BSC treatment initiation will be considered as "success" patients. Patients with a progressive disease and patients who died from any cause at 16 ± 2 weeks after the date of regorafenib + BSC treatment initiation will be considered as "failure" patients. At the time of analysis, if at least 18 "successes" are observed among the 36 analyzed patients, the regorafenib + BSC treatment will be considered as interesting for further investigations in this indication.

Time frame
Up to 16 weeks after the date of regorafenib + BSC treatment initiation

Secondary outcomes

1

Progression-Free Survival (PFS)

PFS will be described from date of regorafenib + BSC treatment initiation to the date first documented disease progression according to RECIST V1.1 or the date of death due to any cause. Patients alive without progression at the time of data cut-off will be censored at the time of latest tumour evaluation.

Time frame
Up to 3 years
2

Objective Response Rate (ORR)

The Objective Response Rate (ORR) will be defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) (RECIST V1.1)

Time frame
Up to 3 years
3

Disease Control Rate (DCR) at 2 months

The Disease Control Rate (DCR) will be defined as the proportion of patients with a best overall response of CR, PR or Stable Disease (SD) (RECIST V1.1) 2 months after randomization

Time frame
2 months
4

Disease Control Rate (DCR) at 4 months

The Disease Control Rate (DCR) will be defined as the proportion of patients with a best overall response of CR, PR or Stable Disease (SD) (RECIST V1.1) 4 months after randomization

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Leon Berard

Lead sponsor

Source ClinicalTrials.gov
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