Trial Outcomes & Findings for Study of Orally Administered TAK-960 in Patients With Advanced Nonhematologic Malignancies (NCT NCT01179399)
NCT ID: NCT01179399
Last Updated: 2014-03-03
Results Overview
Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
up to 12 months
Results posted on
2014-03-03
Participant Flow
Participant milestones
| Measure |
TAK-960
Given orally (PO) for 21 days of a 28-day treatment cycle.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
TAK-960
Given orally (PO) for 21 days of a 28-day treatment cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lack of Efficacy
|
30
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study of Orally Administered TAK-960 in Patients With Advanced Nonhematologic Malignancies
Baseline characteristics by cohort
| Measure |
TAK-960
n=32 Participants
Given orally (PO) for 21 days of a 28-day treatment cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 9.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsPopulation: Maximum tolerable dose (MTD) and recommended phase 2 dose (RP2D) of TAK-960 were not determined due to sponsor decision to discontinue the study for business reasons.
Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)
Outcome measures
Outcome data not reported
Adverse Events
TAK-960
Serious events: 13 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAK-960
n=32 participants at risk
Given orally (PO) for 21 days of a 28-day treatment cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
1/32
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
1/32
|
|
Gastrointestinal disorders
Pancreatitis acute
|
3.1%
1/32
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
3.1%
1/32
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32
|
|
General disorders
Fatigue
|
3.1%
1/32
|
|
General disorders
Non-cardiac chest pain
|
3.1%
1/32
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.1%
1/32
|
|
Hepatobiliary disorders
Hepatic failure
|
3.1%
1/32
|
|
Hepatobiliary disorders
Bile duct obstruction
|
3.1%
1/32
|
|
Infections and infestations
Device related infection
|
3.1%
1/32
|
|
Infections and infestations
Respiratory tract infection
|
3.1%
1/32
|
|
Infections and infestations
Sepsis
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.1%
1/32
|
Other adverse events
| Measure |
TAK-960
n=32 participants at risk
Given orally (PO) for 21 days of a 28-day treatment cycle.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
8/32
|
|
Gastrointestinal disorders
Diarrhoea
|
18.8%
6/32
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
4/32
|
|
Gastrointestinal disorders
Dyspepsia
|
9.4%
3/32
|
|
Nervous system disorders
Headache
|
18.8%
6/32
|
|
Nervous system disorders
Dizziness
|
15.6%
5/32
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
4/32
|
|
Investigations
Aspartate aminotransferase increased
|
9.4%
3/32
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
2/32
|
|
Investigations
Platelet count decreased
|
6.2%
2/32
|
|
Investigations
Weight decreased
|
6.2%
2/32
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.6%
13/32
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
2/32
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
4/32
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.4%
3/32
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.6%
5/32
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
3/32
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.4%
3/32
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
2/32
|
|
General disorders
Pyrexia
|
9.4%
3/32
|
|
General disorders
Oedema peripheral
|
6.2%
2/32
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
6.2%
2/32
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
2/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place