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Alkylating agent

Carboplatin for Glioblastoma (SC9-GBM-01 Trial)

Phase 1 & 2
Waitlist Available
Led By Ahmed IDBAIH, MD
Research Sponsored by CarThera
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 days after the first sonication treatment
Awards & highlights

SC9-GBM-01 Trial Summary

Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9

Eligible Conditions
  • Glioblastoma

SC9-GBM-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 days after the first sonication treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 days after the first sonication treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain
Dose limiting toxicity (DLT) of number of activated ultrasound beams

Side effects data

From 2022 Phase 3 trial • 1301 Patients • NCT03038100
60%
ALOPECIA
51%
NAUSEA
45%
ARTHRALGIA
44%
ANAEMIA
38%
FATIGUE
35%
HYPERTENSION
35%
CONSTIPATION
35%
DIARRHOEA
30%
NEUTROPENIA
28%
PERIPHERAL SENSORY NEUROPATHY
28%
ABDOMINAL PAIN
28%
NEUTROPHIL COUNT DECREASED
24%
NEUROPATHY PERIPHERAL
24%
RASH
23%
HEADACHE
23%
VOMITING
22%
WHITE BLOOD CELL COUNT DECREASED
22%
MYALGIA
21%
PLATELET COUNT DECREASED
21%
PROTEINURIA
21%
EPISTAXIS
21%
THROMBOCYTOPENIA
19%
DECREASED APPETITE
18%
HYPOTHYROIDISM
17%
URINARY TRACT INFECTION
16%
COUGH
16%
PYREXIA
15%
STOMATITIS
14%
HYPOMAGNESAEMIA
14%
ASPARTATE AMINOTRANSFERASE INCREASED
14%
BACK PAIN
14%
INSOMNIA
14%
ALANINE AMINOTRANSFERASE INCREASED
14%
DYSPNOEA
14%
PRURITUS
13%
WEIGHT DECREASED
13%
PAIN IN EXTREMITY
12%
DIZZINESS
12%
INFUSION RELATED REACTION
12%
ASTHENIA
11%
LEUKOPENIA
11%
HYPOKALAEMIA
10%
UPPER RESPIRATORY TRACT INFECTION
9%
DYSGEUSIA
8%
ABDOMINAL PAIN UPPER
8%
FEBRILE NEUTROPENIA
8%
HYPOAESTHESIA
8%
WEIGHT INCREASED
8%
HYPERTHYROIDISM
7%
BONE PAIN
7%
DYSPHONIA
7%
LYMPHOCYTE COUNT DECREASED
7%
MUCOSAL INFLAMMATION
7%
MUSCULAR WEAKNESS
7%
HYPONATRAEMIA
7%
PARAESTHESIA
7%
OROPHARYNGEAL PAIN
7%
DYSPEPSIA
7%
RASH MACULO-PAPULAR
7%
HYPERGLYCAEMIA
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
OEDEMA PERIPHERAL
6%
NASOPHARYNGITIS
6%
ABDOMINAL DISTENSION
6%
ANXIETY
5%
PAIN
5%
DEPRESSION
5%
DRY MOUTH
5%
MALAISE
5%
NASAL CONGESTION
5%
VISION BLURRED
5%
DRY SKIN
5%
URTICARIA
5%
HOT FLUSH
5%
NECK PAIN
4%
GASTROOESOPHAGEAL REFLUX DISEASE
2%
ILEUS
2%
PNEUMONIA
2%
PULMONARY EMBOLISM
2%
COLITIS
2%
SMALL INTESTINAL OBSTRUCTION
1%
PERITONITIS
1%
LIVER INJURY
1%
INTESTINAL OBSTRUCTION
1%
UROSEPSIS
1%
DEHYDRATION
1%
TRANSIENT ISCHAEMIC ATTACK
1%
PNEUMONITIS
1%
ABDOMINAL ABSCESS
1%
INFECTED LYMPHOCELE
1%
PYELONEPHRITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo With Paclitaxel, Carboplatin and Bevacizumab
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

SC9-GBM-01 Trial Design

1Treatment groups
Experimental Treatment
Group I: SonoCloud-9 Ultrasound + CarboplatinExperimental Treatment2 Interventions
SonoCloud-9 Carboplatin: 6 cycles (every 4 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SonoCloud-9
2019
Completed Phase 2
~40
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

CarTheraLead Sponsor
5 Previous Clinical Trials
676 Total Patients Enrolled
3 Trials studying Glioblastoma
642 Patients Enrolled for Glioblastoma
Ahmed IDBAIH, MDPrincipal InvestigatorAPHP
1 Previous Clinical Trials
78 Total Patients Enrolled
1 Trials studying Glioblastoma
78 Patients Enrolled for Glioblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9
2019. "Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03744026.
~6 spots leftby Apr 2025
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