Trial Outcomes & Findings for Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer (NCT NCT04529850)
NCT ID: NCT04529850
Last Updated: 2022-08-16
Results Overview
Number of Subjects with at Least One Treatment Emergent Adverse Event (TEAE)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
First dose of study medication through the 30 days following the last dose of IMRT, GC4419, or cisplatin (whichever occurs last) which is estimated to be 11 weeks
Results posted on
2022-08-16
Participant Flow
A total of 38 subjects were enrolled to the study (signed an ICF). Only 37 of these subjects were dosed on the trial and part of the ITT population (enrolled subjects who received 1 dose of study medication). The 1 subject that was enrolled but was not dosed withdrew their consent prior to treatment.
Participant milestones
| Measure |
Open Label Active Arm
90mg GC4419 by IV
Drug: GC4419: GC4419 60 Minute Infusion
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Open Label Active Arm
90mg GC4419 by IV
Drug: GC4419: GC4419 60 Minute Infusion
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Open Label Active Arm
n=37 Participants
90mg GC4419 by IV
Drug: GC4419: GC4419 60 Minute Infusion
|
|---|---|
|
Age, Customized
Age Group, years · <18
|
0 Participants
n=5 Participants
|
|
Age, Customized
Age Group, years · 18-65
|
25 Participants
n=5 Participants
|
|
Age, Customized
Age Group, years · 66-75
|
10 Participants
n=5 Participants
|
|
Age, Customized
Age Group, years · >75
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First dose of study medication through the 30 days following the last dose of IMRT, GC4419, or cisplatin (whichever occurs last) which is estimated to be 11 weeksPopulation: ITT Population
Number of Subjects with at Least One Treatment Emergent Adverse Event (TEAE)
Outcome measures
| Measure |
Open Label Active Arm
n=37 Participants
90mg GC4419 by IV
Drug: GC4419: GC4419 60 Minute Infusion
|
|---|---|
|
Incidence of Treatment Emergent AE's
TEAE
|
36 Participants
|
|
Incidence of Treatment Emergent AE's
TEAE Leading to Discontinuation of GC4419
|
1 Participants
|
|
Incidence of Treatment Emergent AE's
TEAE Related to GC4419
|
12 Participants
|
|
Incidence of Treatment Emergent AE's
TEAE Related to IMRT
|
33 Participants
|
|
Incidence of Treatment Emergent AE's
TEAE Related to Chemotherapy
|
35 Participants
|
|
Incidence of Treatment Emergent AE's
TEAE Leading to Discontinuation
|
11 Participants
|
|
Incidence of Treatment Emergent AE's
TEAE Leading to Discontinuation of IMRT
|
1 Participants
|
|
Incidence of Treatment Emergent AE's
TEAE Leading to Discontinuation of Chemotherapy
|
10 Participants
|
SECONDARY outcome
Timeframe: From start of Intensity-modulated radiation therapy (IMRT) through approximately 30 fractions which is estimated to be 6-7 weeks.Population: Per Protocol Population defined as subjects who received at least 60 Gy of IMRT and at least 25 doses of GC4419.
Cumulative Incidence of WHO Grade 3-4 from the start of IMRT through the end of the study treatment period (last day of IMRT)
Outcome measures
| Measure |
Open Label Active Arm
n=33 Participants
90mg GC4419 by IV
Drug: GC4419: GC4419 60 Minute Infusion
|
|---|---|
|
Cumulative Incidence of Severe OM
|
54.5 percentage of Subjects with SOM
Interval 36.35 to 71.89
|
Adverse Events
Open Label Active Arm
Serious events: 18 serious events
Other events: 36 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Open Label Active Arm
n=37 participants at risk
90mg GC4419 by IV
Drug: GC4419: GC4419 60 Minute Infusion
|
|---|---|
|
Infections and infestations
Pneumonia
|
8.1%
3/37 • Number of events 3 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Infections and infestations
COVID 19
|
5.4%
2/37 • Number of events 2 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Infections and infestations
Device Related Infection
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Infections and infestations
Stoma Site Infection
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Blood and lymphatic system disorders
Leuokopenia
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Gastrointestinal disorders
Colitis
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Vascular disorders
Hypotension
|
5.4%
2/37 • Number of events 2 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
General disorders
Pyrexia
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Haemorrhage
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Renal and urinary disorders
Renal Failure
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
Other adverse events
| Measure |
Open Label Active Arm
n=37 participants at risk
90mg GC4419 by IV
Drug: GC4419: GC4419 60 Minute Infusion
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
51.4%
19/37 • Number of events 23 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Gastrointestinal disorders
Constipation
|
27.0%
10/37 • Number of events 12 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
21.6%
8/37 • Number of events 8 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Gastrointestinal disorders
Vomiting
|
21.6%
8/37 • Number of events 11 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
18.9%
7/37 • Number of events 11 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
16.2%
6/37 • Number of events 12 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
13.5%
5/37 • Number of events 7 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Gastrointestinal disorders
Oral Pain
|
13.5%
5/37 • Number of events 8 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
67.6%
25/37 • Number of events 32 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
40.5%
15/37 • Number of events 20 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
37.8%
14/37 • Number of events 19 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.0%
10/37 • Number of events 13 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.2%
6/37 • Number of events 8 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
24.3%
9/37 • Number of events 9 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesamia
|
24.3%
9/37 • Number of events 9 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
21.6%
8/37 • Number of events 9 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
General disorders
Asthenia
|
18.9%
7/37 • Number of events 13 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
General disorders
Pyrexia
|
18.9%
7/37 • Number of events 11 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Infections and infestations
Oral Candidiasis
|
10.8%
4/37 • Number of events 4 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
18.9%
7/37 • Number of events 9 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Investigations
Weight Decreased
|
13.5%
5/37 • Number of events 6 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Vascular disorders
Hypotension
|
18.9%
7/37 • Number of events 8 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
|
Injury, poisoning and procedural complications
Radiation Skin Injury
|
18.9%
7/37 • Number of events 10 • Adverse events were collected from the time of the first administration of study drug through 30 days following the last dose of IMRT, cisplatin, or study drug (whichever occurred last) which is estimated to be 11 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI has publication and presentation privileges provided that manuscript/presentation is submitted to the sponsor 60 days prior to submission of the publication or 60 days prior to presentation. PI agrees to remove confidential information of sponsor prior to submission of publication or presentation or defer submission until confidential information can be protected by filing of a patent application. PI cannot publish the results from their site until the sponsor has published multi-site data.
- Publication restrictions are in place
Restriction type: OTHER