NCT02517736

Brief Summary

The objective of the study is to determine the efficacy and toxicity of sorafenib in metastatic uveal melanoma. The main objective is to determine the non-tumor progression rate 24 weeks after initiation of treatment with sorafenib at a dose of 800 mg / day

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
Last Updated

February 17, 2026

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

August 5, 2015

Last Update Submit

February 13, 2026

Conditions

Uveal Melanoma

Outcome Measures

Primary Outcomes (1)

  • non-tumor progression rate

    with sorafenib at a dose of 800 mg / day

    24 weeks after initiation of treatment

Study Arms (1)

sorafenib at a dose of 800 mg / day

EXPERIMENTAL
Drug: Sorafenib at a dose of 800 mg / day

Interventions

Sorafenib at a dose of 800 mg / dayDRUG
sorafenib at a dose of 800 mg / day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female over 18 years old suffering from uveal melanoma with metastasis
  • At least one measurable metastases by more than 10 mm acoording to Response Evaluation Criteria in Solid Tumors (RECIST)
  • At least 28 days from the previous treatment (systemic or major surgery)
  • Performance Index (WHO ≤ 2 or ≥ 70% Karnofsky)
  • Weight loss compared to pre morbid weight \<20% in the last 12 months
  • White blood cells at least 3000 / mm 3, polynuclear neutrophils less than 1500 / mm3, platelets at least 100,000 / mm3, hemoglobin at least 9.0 g / dl
  • Total Bilirubin ≤1.5 x upper limit of normal (ULN) (or less than or equal to 2.5 in liver metastasis), ASAT and ALAT ≤ 2.5 x ULN (or ≤ 5 in liver metastasis) Serum Creatinine (calculated using the cockcroft-Gault method) ≤ 1.5 x ULN, Amylase and lipase \<1.5 x ULN
  • prothrombin rate and international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. Possibility of using low molecular weight heparin in place of anti vitamin K treatment
  • higher life expectancy than or equal to 3 months
  • Negative pregnancy test for women of childbearing age and using a method of contraception during treatment
  • No one benefiting from a Social Security scheme
  • Informed consent and signed by the patient or his legal representative

You may not qualify if:

  • Patient who received more than 2 lines of treatment (chemotherapy or immunotherapy), whatever the indication
  • single liver metastasis treatable by surgery
  • active peptic ulcer, uncontrolled
  • Other progressive malignancy or during treatment (except basal cell carcinoma)
  • Cardiac arrhythmias requiring anti-arrhythmic (excluding beta-blockers or digoxin for chronic atrial fibrillation), active or ischemic coronary disease (myocardial infarction within the last 6 months), or heart failure\> New York Heart Association (NYHA) class II
  • Bacterial or fungal infection active (grade\> 2 Common Toxicity Criteria for Adverse Effects (CTCAE) v4.03)
  • known HIV infection or chronic hepatitis B or C
  • cerebral or meningeal tumor metastasis (symptomatic or asymptomatic)
  • epileptic disease requiring anti-epileptic taken
  • Previous history of organ transplantation or peripheral stem cells
  • Patient kidney dialysis
  • Concomitant treatment with cytochrome P450 3A4 (CYP3A4) inducers such as rifampin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone
  • Prior therapy with bevacizumab or other targeted therapy
  • Known or suspected allergy to sorafenib
  • Any unstable chronic illness can jeopardize patient safety or its compliance
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'ophtalmologie, CHU de Caen

Caen, 14000, France

Location

Related Publications (1)

  • Mouriaux F, Servois V, Parienti JJ, Lesimple T, Thyss A, Dutriaux C, Neidhart-Berard EM, Penel N, Delcambre C, Peyro Saint Paul L, Pham AD, Heutte N, Piperno-Neumann S, Joly F. Sorafenib in metastatic uveal melanoma: efficacy, toxicity and health-related quality of life in a multicentre phase II study. Br J Cancer. 2016 Jun 28;115(1):20-4. doi: 10.1038/bjc.2016.119. Epub 2016 Jun 2.

    PMID: 27253171RESULT

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 7, 2015

Study Start

February 1, 2012

Primary Completion

January 13, 2015

Study Completion

January 13, 2015

Last Updated

February 17, 2026

Record last verified: 2017-01

Locations

FR(1)