Trial Outcomes & Findings for A Phase 2 Biomarker - Enriched Study of TH-302 in Subjects With Advanced Melanoma (NCT NCT01864538)
NCT ID: NCT01864538
Last Updated: 2025-05-11
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
1 year
Results posted on
2025-05-11
Participant Flow
Participant milestones
| Measure |
TH-302
480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2 Biomarker - Enriched Study of TH-302 in Subjects With Advanced Melanoma
Baseline characteristics by cohort
| Measure |
TH-302
n=11 Participants
480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|
|
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
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
10 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
Canada
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
TH-302
n=11 Participants
480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|
|
Overall Survival
|
11 Participants
|
Adverse Events
TH-302
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TH-302
n=11 participants at risk
480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|
|
Infections and infestations
Cellulitis
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • Number of events 2
|
|
Blood and lymphatic system disorders
Splenic thrombosis
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
TH-302
n=11 participants at risk
480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
27.3%
3/11 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
18.2%
2/11 • Number of events 2
|
|
Blood and lymphatic system disorders
Anaemia
|
18.2%
2/11 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
54.5%
6/11 • Number of events 7
|
|
Metabolism and nutrition disorders
Dehydration
|
18.2%
2/11 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11 • Number of events 2
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.3%
3/11 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
3/11 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
27.3%
3/11 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Erythema
|
18.2%
2/11 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
2/11 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.3%
3/11 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
27.3%
3/11 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
18.2%
2/11 • Number of events 2
|
|
Renal and urinary disorders
Dysuria
|
18.2%
2/11 • Number of events 2
|
|
General disorders
Chills
|
18.2%
2/11 • Number of events 3
|
|
General disorders
Fatigue
|
54.5%
6/11 • Number of events 10
|
|
General disorders
Oedema peripheral
|
36.4%
4/11 • Number of events 4
|
|
General disorders
Pyrexia
|
27.3%
3/11 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
2/11 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
18.2%
2/11 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase increased
|
18.2%
2/11 • Number of events 2
|
|
Investigations
Weight decreased
|
27.3%
3/11 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place