Trial Outcomes & Findings for Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED) (NCT NCT00423150)
NCT ID: NCT00423150
Last Updated: 2017-06-08
Results Overview
Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
Temozolomide
Temozolomide capsules 150 mg/m\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
|
|---|---|
|
Overall Study
STARTED
|
86
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
86
|
Reasons for withdrawal
| Measure |
Temozolomide
Temozolomide capsules 150 mg/m\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Progression of disease being studied
|
69
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Non-compliance with protocol
|
1
|
|
Overall Study
Administrative
|
4
|
Baseline Characteristics
Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
Baseline characteristics by cohort
| Measure |
Temozolomide
n=86 Participants
Temozolomide capsules 150 mg/m\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
|
|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes firstPopulation: Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Temozolomide
n=82 Participants
Temozolomide capsules 150 mg/m\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
|
|---|---|
|
Tumor Responses (Complete and Partial Response)
Number of participants with Complete Response
|
0 Participants
|
|
Tumor Responses (Complete and Partial Response)
Number of participants with Partial Response
|
5 Participants
|
Adverse Events
Temozolomide
Serious events: 37 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temozolomide
n=86 participants at risk
Temozolomide capsules 150 mg/m\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
4.7%
4/86 • Number of events 4
Other adverse events: these non-serious events are treatment-emergent.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.3%
2/86 • Number of events 5
Other adverse events: these non-serious events are treatment-emergent.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
4.7%
4/86 • Number of events 7
Other adverse events: these non-serious events are treatment-emergent.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
2.3%
2/86 • Number of events 2
Other adverse events: these non-serious events are treatment-emergent.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.5%
3/86 • Number of events 3
Other adverse events: these non-serious events are treatment-emergent.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Ear and labyrinth disorders
VERTIGO
|
2.3%
2/86 • Number of events 2
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
MELAENA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
NAUSEA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
VOMITING
|
3.5%
3/86 • Number of events 4
Other adverse events: these non-serious events are treatment-emergent.
|
|
General disorders
FATIGUE
|
2.3%
2/86 • Number of events 2
Other adverse events: these non-serious events are treatment-emergent.
|
|
General disorders
MULTI-ORGAN FAILURE
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
General disorders
PYREXIA
|
3.5%
3/86 • Number of events 3
Other adverse events: these non-serious events are treatment-emergent.
|
|
Hepatobiliary disorders
BILE DUCT OBSTRUCTION
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Infections and infestations
BACTERAEMIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Infections and infestations
PNEUMONIA
|
1.2%
1/86 • Number of events 2
Other adverse events: these non-serious events are treatment-emergent.
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Injury, poisoning and procedural complications
ACETABULUM FRACTURE
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Investigations
BLOOD CREATININE INCREASED
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Investigations
BLOOD UREA INCREASED
|
1.2%
1/86 • Number of events 2
Other adverse events: these non-serious events are treatment-emergent.
|
|
Investigations
OXYGEN CONSUMPTION INCREASED
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
3.5%
3/86 • Number of events 3
Other adverse events: these non-serious events are treatment-emergent.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Nervous system disorders
CEREBRAL ARTERY THROMBOSIS
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Nervous system disorders
CONVULSION
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Nervous system disorders
DIZZINESS
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Nervous system disorders
HYPOAESTHESIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Renal and urinary disorders
HAEMATURIA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.8%
5/86 • Number of events 6
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.3%
2/86 • Number of events 2
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
INCREASED UPPER AIRWAY SECRETION
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ACIDOSIS
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Surgical and medical procedures
NEPHROSTOMY TUBE REMOVAL
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Vascular disorders
HYPERTENSION
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
|
Vascular disorders
HYPOTENSION
|
1.2%
1/86 • Number of events 1
Other adverse events: these non-serious events are treatment-emergent.
|
Other adverse events
| Measure |
Temozolomide
n=86 participants at risk
Temozolomide capsules 150 mg/m\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
19.8%
17/86 • Number of events 30
Other adverse events: these non-serious events are treatment-emergent.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
10.5%
9/86 • Number of events 18
Other adverse events: these non-serious events are treatment-emergent.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
22.1%
19/86 • Number of events 55
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.5%
9/86 • Number of events 13
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.6%
22/86 • Number of events 25
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
DIARRHOEA
|
24.4%
21/86 • Number of events 37
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.8%
5/86 • Number of events 8
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
NAUSEA
|
52.3%
45/86 • Number of events 84
Other adverse events: these non-serious events are treatment-emergent.
|
|
Gastrointestinal disorders
VOMITING
|
40.7%
35/86 • Number of events 53
Other adverse events: these non-serious events are treatment-emergent.
|
|
General disorders
ASTHENIA
|
11.6%
10/86 • Number of events 13
Other adverse events: these non-serious events are treatment-emergent.
|
|
General disorders
FATIGUE
|
41.9%
36/86 • Number of events 75
Other adverse events: these non-serious events are treatment-emergent.
|
|
General disorders
OEDEMA PERIPHERAL
|
8.1%
7/86 • Number of events 10
Other adverse events: these non-serious events are treatment-emergent.
|
|
General disorders
PYREXIA
|
8.1%
7/86 • Number of events 13
Other adverse events: these non-serious events are treatment-emergent.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
7.0%
6/86 • Number of events 6
Other adverse events: these non-serious events are treatment-emergent.
|
|
Investigations
PLATELET COUNT DECREASED
|
5.8%
5/86 • Number of events 9
Other adverse events: these non-serious events are treatment-emergent.
|
|
Investigations
WEIGHT DECREASED
|
15.1%
13/86 • Number of events 13
Other adverse events: these non-serious events are treatment-emergent.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
36.0%
31/86 • Number of events 33
Other adverse events: these non-serious events are treatment-emergent.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
8.1%
7/86 • Number of events 11
Other adverse events: these non-serious events are treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.0%
6/86 • Number of events 6
Other adverse events: these non-serious events are treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.8%
5/86 • Number of events 9
Other adverse events: these non-serious events are treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.8%
5/86 • Number of events 6
Other adverse events: these non-serious events are treatment-emergent.
|
|
Nervous system disorders
DIZZINESS
|
12.8%
11/86 • Number of events 16
Other adverse events: these non-serious events are treatment-emergent.
|
|
Nervous system disorders
HEADACHE
|
15.1%
13/86 • Number of events 27
Other adverse events: these non-serious events are treatment-emergent.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
7.0%
6/86 • Number of events 6
Other adverse events: these non-serious events are treatment-emergent.
|
|
Psychiatric disorders
ANXIETY
|
5.8%
5/86 • Number of events 5
Other adverse events: these non-serious events are treatment-emergent.
|
|
Psychiatric disorders
INSOMNIA
|
8.1%
7/86 • Number of events 8
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
12.8%
11/86 • Number of events 12
Other adverse events: these non-serious events are treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.5%
9/86 • Number of events 9
Other adverse events: these non-serious events are treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
8.1%
7/86 • Number of events 8
Other adverse events: these non-serious events are treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
RASH
|
14.0%
12/86 • Number of events 17
Other adverse events: these non-serious events are treatment-emergent.
|
|
Vascular disorders
HYPOTENSION
|
7.0%
6/86 • Number of events 6
Other adverse events: these non-serious events are treatment-emergent.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor, 45 days prior to submission, review copies of abstracts or manuscripts for publication that report any results of the study. If the parties disagree, investigator agrees to meet with the sponsor, prior to submission, for the purpose of making good faith efforts to discuss/resolve any such issues.
- Publication restrictions are in place
Restriction type: OTHER