Trial Outcomes & Findings for Dose-Escalation Study of TH-302 in Combination With Doxorubicin to Treat Patients With Advanced Soft Tissue Sarcoma (NCT NCT00742963)
NCT ID: NCT00742963
Last Updated: 2025-05-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Two years
Results posted on
2025-05-13
Participant Flow
Participant milestones
| Measure |
TH-302 in Combination With Doxorubicin
75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.
TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.
Dose escalation dose levels:
Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
Completed All Treatment Cycles
|
68
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Escalation Study of TH-302 in Combination With Doxorubicin to Treat Patients With Advanced Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
TH-302 in Combination With Doxorubicin
n=101 Participants
75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.
TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.
Dose escalation dose levels:
Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 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
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
101 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two yearsOutcome measures
| Measure |
TH-302 in Combination With Doxorubicin
n=107 Participants
75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.
TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.
Dose escalation dose levels:
Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2
|
|---|---|
|
Maximum Tolerated Dose (MTD) Measured of TH-302 When Used in Combination With Doxorubicin and Prophylactic Growth Factor Support in Subjects With Advanced Soft Tissue Sarcoma
|
300 mg/m2
|
Adverse Events
TH-302 in Combination With Doxorubicin
Serious events: 64 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TH-302 in Combination With Doxorubicin
n=101 participants at risk
75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.
TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.
Dose escalation dose levels:
Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2
|
|---|---|
|
Infections and infestations
Catheter site cellulitis
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Catheter site infection
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Genital herpes
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Infusion site infection
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Metapneumovirus infection
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Necrotising fasciitis
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Neutropenic infection
|
2.0%
2/101 • Number of events 2
|
|
Infections and infestations
Neutropenic sepsis
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Septic shock
|
2.0%
2/101 • Number of events 2
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.99%
1/101 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.99%
1/101 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.99%
1/101 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
2/101 • Number of events 3
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.99%
1/101 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.99%
1/101 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.9%
6/101 • Number of events 6
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.0%
3/101 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
2/101 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.99%
1/101 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.99%
1/101 • Number of events 1
|
|
Cardiac disorders
Atrial tachycardia
|
0.99%
1/101 • Number of events 1
|
|
Vascular disorders
Aortic thrombosis
|
0.99%
1/101 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
2/101 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.99%
1/101 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.99%
1/101 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.99%
1/101 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.99%
1/101 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.99%
1/101 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
3/101 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
2/101 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.99%
1/101 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
2/101 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.99%
1/101 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.99%
1/101 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.99%
1/101 • Number of events 1
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.99%
1/101 • Number of events 1
|
|
General disorders
Asthenia
|
0.99%
1/101 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.99%
1/101 • Number of events 1
|
|
General disorders
Pyrexia
|
4.0%
4/101 • Number of events 4
|
|
Investigations
Body temperature increased
|
0.99%
1/101 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.99%
1/101 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.99%
1/101 • Number of events 1
|
Other adverse events
| Measure |
TH-302 in Combination With Doxorubicin
n=101 participants at risk
75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.
TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.
Dose escalation dose levels:
Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
15.8%
16/101 • Number of events 20
|
|
Blood and lymphatic system disorders
Anaemia
|
71.3%
72/101 • Number of events 104
|
|
Blood and lymphatic system disorders
Leukopenia
|
29.7%
30/101 • Number of events 85
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.7%
31/101 • Number of events 58
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
52.5%
53/101 • Number of events 145
|
|
Metabolism and nutrition disorders
Anorexia
|
39.6%
40/101 • Number of events 44
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.9%
11/101 • Number of events 11
|
|
Metabolism and nutrition disorders
Dehydration
|
11.9%
12/101 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
27.7%
28/101 • Number of events 32
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.9%
12/101 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.8%
18/101 • Number of events 28
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.9%
13/101 • Number of events 16
|
|
Psychiatric disorders
Anxiety
|
10.9%
11/101 • Number of events 12
|
|
Psychiatric disorders
Insomnia
|
11.9%
12/101 • Number of events 13
|
|
Nervous system disorders
Dizziness
|
22.8%
23/101 • Number of events 25
|
|
Nervous system disorders
Dysgeusia
|
16.8%
17/101 • Number of events 25
|
|
Nervous system disorders
Headache
|
21.8%
22/101 • Number of events 30
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.9%
11/101 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.8%
20/101 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.8%
16/101 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.9%
11/101 • Number of events 14
|
|
Gastrointestinal disorders
Abdominal pain
|
15.8%
16/101 • Number of events 16
|
|
Gastrointestinal disorders
Constipation
|
45.5%
46/101 • Number of events 53
|
|
Gastrointestinal disorders
Diarrhoea
|
36.6%
37/101 • Number of events 56
|
|
Gastrointestinal disorders
Dyspepsia
|
12.9%
13/101 • Number of events 14
|
|
Gastrointestinal disorders
Dysphagia
|
14.9%
15/101 • Number of events 16
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.8%
17/101 • Number of events 20
|
|
Gastrointestinal disorders
Nausea
|
74.3%
75/101 • Number of events 110
|
|
Gastrointestinal disorders
Stomatitis
|
48.5%
49/101 • Number of events 61
|
|
Gastrointestinal disorders
Vomiting
|
35.6%
36/101 • Number of events 58
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
53.5%
54/101 • Number of events 55
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
18.8%
19/101 • Number of events 32
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.9%
15/101 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
24.8%
25/101 • Number of events 31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.9%
13/101 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.7%
28/101 • Number of events 37
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.8%
19/101 • Number of events 24
|
|
General disorders
Fatigue
|
69.3%
70/101 • Number of events 83
|
|
General disorders
Oedema peripheral
|
15.8%
16/101 • Number of events 22
|
|
General disorders
Pyrexia
|
24.8%
25/101 • Number of events 33
|
|
Investigations
Blood alkaline phosphatase increased
|
13.9%
14/101 • Number of events 14
|
|
Investigations
Weight decreased
|
19.8%
20/101 • Number of events 20
|
|
Investigations
White blood cell count decreased
|
12.9%
13/101 • Number of events 18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place