Trial Outcomes & Findings for Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer (NCT NCT02047500)
NCT ID: NCT02047500
Last Updated: 2025-05-11
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Up to Day 28 of Cycle 1
Results posted on
2025-05-11
Participant Flow
Participant milestones
| Measure |
TH-302 Plus Nab-paclitaxel Plus Gemcitabine
TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
TH-302 Plus Nab-paclitaxel Plus Gemcitabine
n=19 Participants
TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28 of Cycle 1Population: One patient not evaluable as they did not complete cycle 1
Outcome measures
| Measure |
TH-302 Plus Nab-paclitaxel Plus Gemcitabine
n=18 Participants
TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
|
|---|---|
|
Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
|
1 Participants
|
SECONDARY outcome
Timeframe: Time from enrollment to progressive disease (PD) or occurrence of death due to any cause within 120 days of either first administration of study drug or the last tumor assessmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 weeks after Day 1 of Cycle 1Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 30 after the last dose of study treatmentOutcome measures
Outcome data not reported
Adverse Events
TH-302 Plus Nab-paclitaxel Plus Gemcitabine
Serious events: 19 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TH-302 Plus Nab-paclitaxel Plus Gemcitabine
n=19 participants at risk
TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
|
|---|---|
|
Infections and infestations
Cellulitis of male external genital organ
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
10.5%
2/19 • Number of events 3
|
|
Infections and infestations
Sepsis
|
15.8%
3/19 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Syncope
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
5.3%
1/19 • Number of events 3
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
5.3%
1/19 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct obstruction
|
5.3%
1/19 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
5.3%
1/19 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis acute
|
5.3%
1/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.3%
1/19 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Chest pain
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Number of events 1
|
Other adverse events
| Measure |
TH-302 Plus Nab-paclitaxel Plus Gemcitabine
n=19 participants at risk
TH-302: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Nab-paclitaxel: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Gemcitabine: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
|
|---|---|
|
Infections and infestations
Oral herpes
|
10.5%
2/19 • Number of events 3
|
|
Blood and lymphatic system disorders
Anaemia
|
68.4%
13/19 • Number of events 57
|
|
Blood and lymphatic system disorders
Leukopenia
|
42.1%
8/19 • Number of events 132
|
|
Blood and lymphatic system disorders
Neutropenia
|
73.7%
14/19 • Number of events 88
|
|
Blood and lymphatic system disorders
Pancytopenia
|
10.5%
2/19 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
78.9%
15/19 • Number of events 99
|
|
Metabolism and nutrition disorders
Decreased appetite
|
47.4%
9/19 • Number of events 14
|
|
Metabolism and nutrition disorders
Dehydration
|
15.8%
3/19 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.5%
2/19 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
21.1%
4/19 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.5%
2/19 • Number of events 5
|
|
Psychiatric disorders
Anxiety
|
10.5%
2/19 • Number of events 2
|
|
Psychiatric disorders
Depression
|
10.5%
2/19 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
21.1%
4/19 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
21.1%
4/19 • Number of events 4
|
|
Nervous system disorders
Dysgeusia
|
15.8%
3/19 • Number of events 3
|
|
Nervous system disorders
Headache
|
21.1%
4/19 • Number of events 4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
47.4%
9/19 • Number of events 21
|
|
Ear and labyrinth disorders
Tinnitus
|
10.5%
2/19 • Number of events 2
|
|
Vascular disorders
Flushing
|
15.8%
3/19 • Number of events 6
|
|
Vascular disorders
Hot flush
|
10.5%
2/19 • Number of events 3
|
|
Vascular disorders
Hypotension
|
15.8%
3/19 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.6%
6/19 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.3%
5/19 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.5%
2/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.1%
4/19 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.8%
3/19 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
36.8%
7/19 • Number of events 10
|
|
Gastrointestinal disorders
Abdominal pain lower
|
10.5%
2/19 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.8%
3/19 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
42.1%
8/19 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhoea
|
47.4%
9/19 • Number of events 12
|
|
Gastrointestinal disorders
Flatulence
|
10.5%
2/19 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
68.4%
13/19 • Number of events 20
|
|
Gastrointestinal disorders
Proctalgia
|
15.8%
3/19 • Number of events 3
|
|
Gastrointestinal disorders
Stomatitis
|
31.6%
6/19 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
47.4%
9/19 • Number of events 17
|
|
Hepatobiliary disorders
Bile duct obstruction
|
10.5%
2/19 • Number of events 2
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
10.5%
2/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
63.2%
12/19 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.5%
2/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
2/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
52.6%
10/19 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.5%
2/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.8%
3/19 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
2/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.5%
2/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.5%
2/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
26.3%
5/19 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.8%
3/19 • Number of events 4
|
|
Renal and urinary disorders
Pollakiuria
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Chills
|
42.1%
8/19 • Number of events 13
|
|
General disorders
Fatigue
|
73.7%
14/19 • Number of events 27
|
|
General disorders
Infusion site rash
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Mucosal inflammation
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
15.8%
3/19 • Number of events 3
|
|
General disorders
Oedema peripheral
|
42.1%
8/19 • Number of events 12
|
|
General disorders
Pyrexia
|
36.8%
7/19 • Number of events 12
|
|
Investigations
Neutrophil count decreased
|
15.8%
3/19 • Number of events 11
|
|
Investigations
Weight decreased
|
31.6%
6/19 • Number of events 11
|
|
Investigations
White blood cell count decreased
|
10.5%
2/19 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place