Trial Outcomes & Findings for TH-302 in Combination With Bevacizumab for Glioblastoma (NCT NCT02342379)
NCT ID: NCT02342379
Last Updated: 2020-04-10
Results Overview
Safety lab tests and adverse event assessment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
4 months
Results posted on
2020-04-10
Participant Flow
Participant milestones
| Measure |
Bevacizumab and TH-302
Patients will be treated with combination of bevacizumab and TH-302.
Bevacizumab: 10mg/kg
TH-302: 670mg/m2
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TH-302 in Combination With Bevacizumab for Glioblastoma
Baseline characteristics by cohort
| Measure |
Bevacizumab and TH-302
n=35 Participants
Patients will be treated with combination of bevacizumab and TH-302.
Bevacizumab: 10mg/kg
TH-302: 670mg/m2
|
|---|---|
|
Age, Customized
18-21 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
22-29 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
11 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White : Female
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White : Male
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American : Female
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American : Male
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Hispanic or Latino : Female
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Hispanic or Latino : Male
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian : Female
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian : Male
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsSafety lab tests and adverse event assessment
Outcome measures
| Measure |
Bevacizumab and TH-302
n=35 Participants
Patients will be treated with combination of bevacizumab and TH-302.
Bevacizumab: 10mg/kg
TH-302: 670mg/m2
|
|---|---|
|
Number of Patients With Adverse Events
|
35 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 3 of the enrolled participants were not evaluable
Progression of disease by RANO criteria: The RANO criteria divides response into four types of response based on imaging and clinical features 1. complete response 2. partial response 3. stable disease 4. progression
Outcome measures
| Measure |
Bevacizumab and TH-302
n=32 Participants
Patients will be treated with combination of bevacizumab and TH-302.
Bevacizumab: 10mg/kg
TH-302: 670mg/m2
|
|---|---|
|
Progression Free Survival
|
32 Number of participants
|
Adverse Events
Bevacizumab and TH-302
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bevacizumab and TH-302
n=35 participants at risk
Patients will be treated with combination of bevacizumab and TH-302.
Bevacizumab: 10mg/kg
TH-302: 670mg/m2
|
|---|---|
|
Skin and subcutaneous tissue disorders
Abscess (left axillary abscess)
|
5.7%
2/35 • Number of events 3 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Blood and lymphatic system disorders
Anemia
|
8.6%
3/35 • Number of events 6 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Anorexia
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Nervous system disorders
Cognitive Disturbance
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Nervous system disorders
confusion
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Constipation
|
8.6%
3/35 • Number of events 3 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Decreased Appetite
|
5.7%
2/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Blood and lymphatic system disorders
Decreased Platelets
|
5.7%
2/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.9%
1/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
2/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.7%
2/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Blood and lymphatic system disorders
Edema (pedal)
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Vascular disorders
Epistaxis (intermittent)
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Facial Erythema
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Eye disorders
Blurred vision/diplopia
|
5.7%
2/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
General disorders
Fatigue
|
34.3%
12/35 • Number of events 13 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
General disorders
Fever
|
2.9%
1/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Nervous system disorders
Headache
|
5.7%
2/35 • Number of events 3 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Heartburn
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Hemorrhoid
|
5.7%
2/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Infections and infestations
Herpes Simplex Virus
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarsness
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Endocrine disorders
Hyperglycemia
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
17.1%
6/35 • Number of events 6 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Cardiac disorders
Hypertension
|
5.7%
2/35 • Number of events 3 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Kratoderma
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.7%
2/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection (PNA)
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Mouth Sores
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Anal Mucositis
|
17.1%
6/35 • Number of events 7 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Oral Mucositis
|
14.3%
5/35 • Number of events 9 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Perianal Mucositis
|
8.6%
3/35 • Number of events 6 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Rectal Mucositis
|
5.7%
2/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Reproductive system and breast disorders
Vaginal Mucositis
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Nausea
|
17.1%
6/35 • Number of events 9 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.4%
4/35 • Number of events 9 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Pain, abdominal
|
5.7%
2/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Pain, rectal
|
5.7%
2/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Blood and lymphatic system disorders
Phlebitis
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Endocrine disorders
Proteinuria
|
5.7%
2/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.9%
1/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.7%
9/35 • Number of events 11 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Scar
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Skin Abrasion
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Skin Atrophy
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Skin excoriation
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Other skin excoriation
|
2.9%
1/35 • Number of events 2 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
17.1%
6/35 • Number of events 9 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Small intestine perforation
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
7/35 • Number of events 19 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Renal and urinary disorders
Dysuria
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
5.7%
2/35 • Number of events 3 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Reproductive system and breast disorders
Vaginal Infection
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
3/35 • Number of events 5 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
General disorders
Weakness
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
|
Skin and subcutaneous tissue disorders
Wound complication
|
2.9%
1/35 • Number of events 1 • Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.
|
Additional Information
Andrew Brenner, MD, PhD
University of Texas Health San Antonio
Phone: 210-450-5936
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place