Trial Outcomes & Findings for Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma (NCT NCT01144455)
NCT ID: NCT01144455
Last Updated: 2025-05-11
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
214 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Results posted on
2025-05-11
Participant Flow
Participant milestones
| Measure |
Gemcitabine
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
|
240 mg/m2 TH-302 + Gemcitabine
TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
|
340 mg/m2 TH-302 + Gemcitabine
TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
69
|
71
|
74
|
|
Overall Study
COMPLETED
|
19
|
29
|
38
|
|
Overall Study
NOT COMPLETED
|
50
|
42
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Gemcitabine
n=69 Participants
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
|
240 mg/m2 TH-302 + Gemcitabine
n=71 Participants
TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
|
340 mg/m2 TH-302 + Gemcitabine
n=74 Participants
TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 yearProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Gemcitabine
n=69 Participants
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
|
240 mg/m2 TH-302 + Gemcitabine
n=71 Participants
TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
|
340 mg/m2 TH-302 + Gemcitabine
n=74 Participants
TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
111 days
Interval 101.0 to 148.0
|
169 days
Interval 130.0 to 211.0
|
183 days
Interval 149.0 to 223.0
|
Adverse Events
Gemcitabine
Serious events: 37 serious events
Other events: 69 other events
Deaths: 0 deaths
240 mg/m2 TH-302 + Gemcitabine
Serious events: 35 serious events
Other events: 71 other events
Deaths: 0 deaths
340 mg/m2 TH-302 + Gemcitabine
Serious events: 43 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine
n=69 participants at risk
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
|
240 mg/m2 TH-302 + Gemcitabine
n=71 participants at risk
TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
|
340 mg/m2 TH-302 + Gemcitabine
n=74 participants at risk
TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
|
|---|---|---|---|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Infections and infestations
Appendicitis
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/69 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
1.4%
1/74 • Number of events 1
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/69
|
0.00%
0/71
|
2.7%
2/74 • Number of events 2
|
|
Infections and infestations
Cellulitis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
4.1%
3/74 • Number of events 5
|
|
Infections and infestations
Clostridium difficile colitis
|
1.4%
1/69 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
1.4%
1/74 • Number of events 2
|
|
Infections and infestations
Device related infection
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 2
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Infections and infestations
Escherichia sepsis
|
1.4%
1/69 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
1.4%
1/74 • Number of events 1
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Infections and infestations
Klebsiella sepsis
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Infections and infestations
Liver abscess
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Infections and infestations
Pneumonia
|
5.8%
4/69 • Number of events 4
|
4.2%
3/71 • Number of events 4
|
4.1%
3/74 • Number of events 3
|
|
Infections and infestations
Sepsis
|
0.00%
0/69
|
1.4%
1/71 • Number of events 2
|
5.4%
4/74 • Number of events 4
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Infections and infestations
Septic shock
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Infections and infestations
Streptococcal bacteraemia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/69 • Number of events 1
|
2.8%
2/71 • Number of events 2
|
2.7%
2/74 • Number of events 4
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.4%
1/69 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Blood and lymphatic system disorders
Anaemia
|
4.3%
3/69 • Number of events 3
|
1.4%
1/71 • Number of events 2
|
1.4%
1/74 • Number of events 1
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
5.4%
4/74 • Number of events 4
|
|
Blood and lymphatic system disorders
Hypoprothrombinaemia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
6.8%
5/74 • Number of events 5
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
4.1%
3/74 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
1.4%
1/74 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
5.8%
4/69 • Number of events 4
|
0.00%
0/71
|
2.7%
2/74 • Number of events 2
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
1.4%
1/74 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
2.7%
2/74 • Number of events 2
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/69 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
1.4%
1/74 • Number of events 1
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
1.4%
1/69 • Number of events 2
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Cardiac disorders
Atrial tachycardia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Cardiac disorders
Bradycardia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Vascular disorders
Deep vein thrombosis
|
2.9%
2/69 • Number of events 2
|
1.4%
1/71 • Number of events 1
|
1.4%
1/74 • Number of events 1
|
|
Vascular disorders
Hypotension
|
5.8%
4/69 • Number of events 4
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
2/69 • Number of events 2
|
0.00%
0/71
|
0.00%
0/74
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
2/69 • Number of events 2
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.3%
3/69 • Number of events 3
|
2.8%
2/71 • Number of events 2
|
8.1%
6/74 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
3/69 • Number of events 3
|
5.6%
4/71 • Number of events 4
|
6.8%
5/74 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
2.9%
2/69 • Number of events 2
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/69 • Number of events 1
|
2.8%
2/71 • Number of events 2
|
2.7%
2/74 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/69
|
2.8%
2/71 • Number of events 2
|
0.00%
0/74
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/69 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
1.4%
1/74 • Number of events 1
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.9%
2/69 • Number of events 2
|
5.6%
4/71 • Number of events 4
|
5.4%
4/74 • Number of events 5
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/69
|
2.8%
2/71 • Number of events 2
|
0.00%
0/74
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/69
|
0.00%
0/71
|
2.7%
2/74 • Number of events 2
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/69
|
1.4%
1/71 • Number of events 2
|
0.00%
0/74
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
2.7%
2/74 • Number of events 2
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
2.7%
2/74 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
2/69 • Number of events 2
|
4.2%
3/71 • Number of events 3
|
6.8%
5/74 • Number of events 7
|
|
Hepatobiliary disorders
Bile duct obstruction
|
5.8%
4/69 • Number of events 4
|
5.6%
4/71 • Number of events 5
|
4.1%
3/74 • Number of events 3
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
7.2%
5/69 • Number of events 6
|
2.8%
2/71 • Number of events 3
|
2.7%
2/74 • Number of events 3
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/69
|
1.4%
1/71 • Number of events 2
|
0.00%
0/74
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
1/69 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
General disorders
Chest pain
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
General disorders
Chills
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
General disorders
Device occlusion
|
4.3%
3/69 • Number of events 3
|
1.4%
1/71 • Number of events 2
|
2.7%
2/74 • Number of events 3
|
|
General disorders
Fatigue
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
2.7%
2/74 • Number of events 2
|
|
General disorders
General physical health deterioration
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
General disorders
Infusion site extravasation
|
0.00%
0/69
|
0.00%
0/71
|
1.4%
1/74 • Number of events 1
|
|
General disorders
Pyrexia
|
1.4%
1/69 • Number of events 1
|
4.2%
3/71 • Number of events 3
|
2.7%
2/74 • Number of events 3
|
|
General disorders
Stent malfunction
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
General disorders
Sudden death
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
0.00%
0/74
|
Other adverse events
| Measure |
Gemcitabine
n=69 participants at risk
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
|
240 mg/m2 TH-302 + Gemcitabine
n=71 participants at risk
TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
|
340 mg/m2 TH-302 + Gemcitabine
n=74 participants at risk
TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
|
|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
10.1%
7/69 • Number of events 8
|
8.5%
6/71 • Number of events 8
|
23.0%
17/74 • Number of events 24
|
|
Blood and lymphatic system disorders
Anaemia
|
43.5%
30/69 • Number of events 34
|
50.7%
36/71 • Number of events 60
|
51.4%
38/74 • Number of events 67
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
1/69 • Number of events 2
|
14.1%
10/71 • Number of events 18
|
14.9%
11/74 • Number of events 23
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.7%
15/69 • Number of events 21
|
38.0%
27/71 • Number of events 69
|
43.2%
32/74 • Number of events 113
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
29.0%
20/69 • Number of events 32
|
50.7%
36/71 • Number of events 104
|
58.1%
43/74 • Number of events 216
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.2%
16/69 • Number of events 16
|
23.9%
17/71 • Number of events 20
|
33.8%
25/74 • Number of events 32
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
6/69 • Number of events 6
|
15.5%
11/71 • Number of events 12
|
16.2%
12/74 • Number of events 15
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.9%
11/69 • Number of events 14
|
14.1%
10/71 • Number of events 12
|
21.6%
16/74 • Number of events 19
|
|
Psychiatric disorders
Insomnia
|
11.6%
8/69 • Number of events 8
|
16.9%
12/71 • Number of events 12
|
13.5%
10/74 • Number of events 10
|
|
Nervous system disorders
Dizziness
|
14.5%
10/69 • Number of events 10
|
5.6%
4/71 • Number of events 4
|
10.8%
8/74 • Number of events 13
|
|
Nervous system disorders
Dysgeusia
|
7.2%
5/69 • Number of events 5
|
7.0%
5/71 • Number of events 5
|
16.2%
12/74 • Number of events 14
|
|
Nervous system disorders
Headache
|
10.1%
7/69 • Number of events 7
|
9.9%
7/71 • Number of events 8
|
12.2%
9/74 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.2%
5/69 • Number of events 6
|
15.5%
11/71 • Number of events 12
|
12.2%
9/74 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.9%
11/69 • Number of events 14
|
22.5%
16/71 • Number of events 17
|
16.2%
12/74 • Number of events 15
|
|
Gastrointestinal disorders
Abdominal distension
|
5.8%
4/69 • Number of events 5
|
14.1%
10/71 • Number of events 10
|
13.5%
10/74 • Number of events 10
|
|
Gastrointestinal disorders
Abdominal pain
|
15.9%
11/69 • Number of events 11
|
29.6%
21/71 • Number of events 22
|
27.0%
20/74 • Number of events 23
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.6%
8/69 • Number of events 10
|
12.7%
9/71 • Number of events 10
|
8.1%
6/74 • Number of events 9
|
|
Gastrointestinal disorders
Constipation
|
31.9%
22/69 • Number of events 25
|
32.4%
23/71 • Number of events 28
|
33.8%
25/74 • Number of events 32
|
|
Gastrointestinal disorders
Diarrhoea
|
24.6%
17/69 • Number of events 23
|
28.2%
20/71 • Number of events 23
|
36.5%
27/74 • Number of events 34
|
|
Gastrointestinal disorders
Nausea
|
39.1%
27/69 • Number of events 32
|
36.6%
26/71 • Number of events 36
|
41.9%
31/74 • Number of events 47
|
|
Gastrointestinal disorders
Stomatitis
|
7.2%
5/69 • Number of events 5
|
18.3%
13/71 • Number of events 15
|
36.5%
27/74 • Number of events 35
|
|
Gastrointestinal disorders
Vomiting
|
27.5%
19/69 • Number of events 27
|
21.1%
15/71 • Number of events 24
|
35.1%
26/74 • Number of events 39
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
6/69 • Number of events 6
|
11.3%
8/71 • Number of events 8
|
16.2%
12/74 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.8%
4/69 • Number of events 4
|
25.4%
18/71 • Number of events 24
|
23.0%
17/74 • Number of events 26
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.2%
5/69 • Number of events 5
|
14.1%
10/71 • Number of events 13
|
9.5%
7/74 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.6%
8/69 • Number of events 9
|
12.7%
9/71 • Number of events 9
|
23.0%
17/74 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.5%
10/69 • Number of events 10
|
8.5%
6/71 • Number of events 7
|
12.2%
9/74 • Number of events 10
|
|
General disorders
Chills
|
10.1%
7/69 • Number of events 7
|
11.3%
8/71 • Number of events 13
|
16.2%
12/74 • Number of events 17
|
|
General disorders
Fatigue
|
42.0%
29/69 • Number of events 34
|
59.2%
42/71 • Number of events 49
|
54.1%
40/74 • Number of events 51
|
|
General disorders
Oedema peripheral
|
40.6%
28/69 • Number of events 35
|
36.6%
26/71 • Number of events 33
|
41.9%
31/74 • Number of events 42
|
|
General disorders
Pyrexia
|
23.2%
16/69 • Number of events 21
|
25.4%
18/71 • Number of events 28
|
24.3%
18/74 • Number of events 25
|
|
Investigations
Alanine aminotransferase increased
|
10.1%
7/69 • Number of events 8
|
14.1%
10/71 • Number of events 12
|
9.5%
7/74 • Number of events 10
|
|
Investigations
Blood alkaline phosphatase increased
|
5.8%
4/69 • Number of events 5
|
23.9%
17/71 • Number of events 18
|
10.8%
8/74 • Number of events 9
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.2%
5/69 • Number of events 5
|
15.5%
11/71 • Number of events 16
|
8.1%
6/74 • Number of events 8
|
|
Investigations
Neutrophil count decreased
|
17.4%
12/69 • Number of events 17
|
22.5%
16/71 • Number of events 32
|
23.0%
17/74 • Number of events 36
|
|
Investigations
Platelet count decreased
|
14.5%
10/69 • Number of events 13
|
23.9%
17/71 • Number of events 37
|
18.9%
14/74 • Number of events 28
|
|
Investigations
Weight decreased
|
13.0%
9/69 • Number of events 9
|
9.9%
7/71 • Number of events 7
|
14.9%
11/74 • Number of events 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place