BRF116013 : Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects With Advanced BRAF V600-Mutation Positive Solid Tumors

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

1-17Age 1-17

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Bowel (colorectum),Brain and spinal cord,Breast,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAnus,Astrocytoma,Basal cell carcinoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Glioma,Kidney,Leiomyosarcoma,Liposarcoma,Liver,Medullablastoma,Melanoma (Ocular),Melanoma (Skin),Meningioma,Merkel cell,Mesothelioma,Neuroblastoma,Neuroendocrine tumours,Non-Small Cell Lung Cancer,Nose (nasopharynx),Oesophagus,Oral cavity,Oropharynx,Osteosarcoma,Ovary,Pancreas,Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Stomach,Synovial Sarcoma,Testis,Throat (hypopharynx),Thyroid,Urinary tract,Urothelial,Uterus,Vagina,Voice box (larynx),Vulva,Wilm's tumour

Trial Overview Read MoreRead more

This phase I trial is evaluating an oral drug (dabrafenib) for children and adolescents with advanced BRAF V600-mutation positive cancers.
 

This trial is treating patients with advanced cancers that have the BRAF V600-Mutation.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects With Advanced BRAF V600-Mutation Positive Solid Tumors

Commercial Sponsor

GlaxoSmithKline

Summary

This is a 2-part, study to determine the safety, tolerability and pharmacokinetics of oral dabrafenib in children and adolescent subjects with advanced BRAF V600 mutation-positive solid tumors. Part 1 (dose escalation study) will identify the recommended Part 2 (tumor-specific expansion study) dose and regimen using a dose-escalation procedure. Approximately 6 to 18 subjects will participate in Part 1 and will receive a starting dose of 3 mg/kg and dose will deescalate or escalate between 1.5 milligram (mg)/kilogram (kg) and 6 mg/kg. Up to 6 subjects will be enrolled at one dose level dependent upon the number of subjects at the current dose level, the number of subjects who have experienced a dose limiting toxicity (DLT) at the current dose level, and the number of subjects enrolled but with data pending at the current dose level. Escalation may proceed until either a maximum tolerated dose (MTD) is established, or until the dose in which the median pharmacokinetic parameters consistent with exposure in adults are achieved. Cohorts may be added in order to evaluate additional dose levels. Part 2 consists of four disease-specific cohorts of subjects with tumors known to have BRAF V600 activation (pediatric low-grade gliomas, pediatric high-grade gliomas, Langerhans cell histiocytosis [LCH], and other tumors such as melanoma and papillary thyroid carcinoma [PTC]). Each cohort will enroll at least 10 subjects with a pre-dose and at least 1 post-dose disease assessment. In both the parts of the study, on Day 1, a single first dose will be administered, and repeat dosing will begin on Day 2. PK sampling will be performed on Day 1 and Day 15 for subjects >=25 kg in weight. For subjects =10 kg in weight, blood samples for PK analysis will be collected on Day 1 and Day 15. For subjects <10kg in="" weight,="" blood="" samples="" for="" pk="" analysis="" will="" be="" collected="" after="" repeated="" administration="" on="" day="" 15="" only.="" safety="" and="" tolerability="" will="" be="" assessed="" throughout="" the="" study.="" treatment="" with="" dabrafenib="" will="" be="" continued="" until="" disease="" progression="" or="" until="" no="" clinical="" benefit="" or="" development="" of="" an="" unacceptable="" toxicity,="" or="" until="" they="" withdraw="" consent="" or="" begin="" a="" new="" therapy.="" at="" the="" end="" of="" treatment,="" a="" final="" study="" visit="" will="">

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Ms Kahlia Fox
kahlia.fox@mcri.edu.au
(03) 9345 6214

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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