Trial Outcomes & Findings for A Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Patients With Solid Tumors (0683-048) (NCT NCT00373490)
NCT ID: NCT00373490
Last Updated: 2015-08-27
Results Overview
Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
21 Days (first cycle)
Results posted on
2015-08-27
Participant Flow
Phase I. First participant started on study therapy on 18-Jul-2006. Study was multicenter (total of 3 sites).
Study of 2 doses of vorinostat (MK-0683) in participants with solid tumors who failed standard therapy. \>= 3 participants were enrolled at each dose. In the case of a dose level toxicity, a maximum of 6 participants were enrolled per level. If no safety problems, a total of 10 participants were evaluated for pharmacokinetics.
Participant milestones
| Measure |
Vorinostat 600 mg
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
Vorinostat 600 mg
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
9
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Patients With Solid Tumors (0683-048)
Baseline characteristics by cohort
| Measure |
Vorinostat 600 mg
n=10 Participants
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
n=6 Participants
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 12 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Prior chemotherapy regimens
|
3.5 Number of prior chemotherapy regimens
n=5 Participants
|
4.5 Number of prior chemotherapy regimens
n=7 Participants
|
4 Number of prior chemotherapy regimens
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 Days (first cycle)Population: Six (6) participants received vorinostat at 400 mg once daily. Of these, 2 participants did not complete the first cycle resulting in the drug compliance falling below 75%, and thus these participants were excluded from the DLT assessment.
Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment
Outcome measures
| Measure |
Vorinostat 600 mg
n=10 Participants
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
n=4 Participants
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|---|---|---|
|
Number of Participants With a Dose Limiting Toxicity (DLT)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 (600 mg and 400 mg)Population: Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1.
Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (o- ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). At 600 mg, t=12 hours and at 400 mg, t=24 hours.
Outcome measures
| Measure |
Vorinostat 600 mg
n=10 Participants
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
n=5 Participants
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|---|---|---|
|
Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)
|
3.94 μM·hr
Standard Deviation 1.56
|
7.75 μM·hr
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Day 3 (600 mg)Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 12) plus AUC (12 - ∞)
Outcome measures
| Measure |
Vorinostat 600 mg
n=10 Participants
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|---|---|---|
|
Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)
|
4.15 μM·hr
Standard Deviation 2.15
|
—
|
SECONDARY outcome
Timeframe: Day 21 (400 mg)Population: Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21.
Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 24) plus AUC (24 - ∞)
Outcome measures
| Measure |
Vorinostat 600 mg
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
n=2 Participants
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|---|---|---|
|
Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)
|
—
|
8.3 μM·hr
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Day 1 (600 mg and 400 mg)Population: Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1.
Outcome measures
| Measure |
Vorinostat 600 mg
n=10 Participants
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
n=5 Participants
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|---|---|---|
|
Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)
|
1.17 μM
Standard Deviation 0.43
|
1.62 μM
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Day 3 (600 mg)Outcome measures
| Measure |
Vorinostat 600 mg
n=10 Participants
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|---|---|---|
|
Maximum Concentration (Cmax) at Day 3 (600 mg)
|
1.32 μM
Standard Deviation 0.75
|
—
|
SECONDARY outcome
Timeframe: Day 21 (400 mg)Population: Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21.
Outcome measures
| Measure |
Vorinostat 600 mg
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
n=2 Participants
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|---|---|---|
|
Maximum Concentration (Cmax) at Day 21 (400 mg)
|
—
|
2.04 μM
Standard Deviation 0.78
|
Adverse Events
Vorinostat 600 mg
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Vorinostat 400 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vorinostat 600 mg
n=10 participants at risk
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
n=6 participants at risk
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
VOMITING
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
DISEASE PROGRESSION
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
Other adverse events
| Measure |
Vorinostat 600 mg
n=10 participants at risk
600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
|
Vorinostat 400 mg
n=6 participants at risk
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
40.0%
4/10 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
PALPITATIONS
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Ear and labyrinth disorders
EAR CONGESTION
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Ear and labyrinth disorders
TINNITUS
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Ear and labyrinth disorders
VERTIGO
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.0%
1/10 • Number of events 5
|
16.7%
1/6 • Number of events 3
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
ACETONAEMIC VOMITING
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
ASCITES
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/10
|
33.3%
2/6 • Number of events 4
|
|
Gastrointestinal disorders
CONSTIPATION
|
60.0%
6/10 • Number of events 7
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
40.0%
4/10 • Number of events 27
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
ERUCTATION
|
10.0%
1/10 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
80.0%
8/10 • Number of events 28
|
100.0%
6/6 • Number of events 12
|
|
Gastrointestinal disorders
STOMACH DISCOMFORT
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/10
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
VOMITING
|
50.0%
5/10 • Number of events 14
|
83.3%
5/6 • Number of events 13
|
|
General disorders
CATHETER SITE PAIN
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
CHEST DISCOMFORT
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
CHEST PAIN
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
CHILLS
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
FATIGUE
|
80.0%
8/10 • Number of events 48
|
66.7%
4/6 • Number of events 5
|
|
General disorders
FEELING ABNORMAL
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
MALAISE
|
20.0%
2/10 • Number of events 11
|
0.00%
0/6
|
|
General disorders
OEDEMA
|
20.0%
2/10 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
|
General disorders
PAIN
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
PYREXIA
|
20.0%
2/10 • Number of events 2
|
33.3%
2/6 • Number of events 3
|
|
General disorders
THIRST
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Hepatobiliary disorders
CHOLANGITIS
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
PYELONEPHRITIS
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
CONTUSION
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME SHORTENED
|
10.0%
1/10 • Number of events 2
|
0.00%
0/6
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
30.0%
3/10 • Number of events 4
|
33.3%
2/6 • Number of events 3
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
60.0%
6/10 • Number of events 12
|
50.0%
3/6 • Number of events 3
|
|
Investigations
BLOOD ALBUMIN DECREASED
|
20.0%
2/10 • Number of events 2
|
50.0%
3/6 • Number of events 4
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
30.0%
3/10 • Number of events 5
|
50.0%
3/6 • Number of events 3
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
30.0%
3/10 • Number of events 12
|
50.0%
3/6 • Number of events 6
|
|
Investigations
BLOOD CALCIUM DECREASED
|
20.0%
2/10 • Number of events 5
|
0.00%
0/6
|
|
Investigations
BLOOD CHLORIDE DECREASED
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Investigations
BLOOD CREATININE INCREASED
|
50.0%
5/10 • Number of events 9
|
83.3%
5/6 • Number of events 12
|
|
Investigations
BLOOD GLUCOSE DECREASED
|
30.0%
3/10 • Number of events 4
|
0.00%
0/6
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
60.0%
6/10 • Number of events 11
|
83.3%
5/6 • Number of events 8
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
20.0%
2/10 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
|
Investigations
BLOOD MAGNESIUM DECREASED
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
BLOOD MAGNESIUM INCREASED
|
30.0%
3/10 • Number of events 5
|
50.0%
3/6 • Number of events 6
|
|
Investigations
BLOOD PHOSPHORUS DECREASED
|
50.0%
5/10 • Number of events 11
|
16.7%
1/6 • Number of events 2
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
0.00%
0/10
|
16.7%
1/6 • Number of events 2
|
|
Investigations
BLOOD POTASSIUM INCREASED
|
30.0%
3/10 • Number of events 12
|
16.7%
1/6 • Number of events 1
|
|
Investigations
BLOOD SODIUM DECREASED
|
40.0%
4/10 • Number of events 6
|
16.7%
1/6 • Number of events 1
|
|
Investigations
BLOOD URIC ACID DECREASED
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
HAEMOGLOBIN DECREASED
|
20.0%
2/10 • Number of events 3
|
33.3%
2/6 • Number of events 4
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
50.0%
5/10 • Number of events 6
|
0.00%
0/6
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
50.0%
5/10 • Number of events 12
|
66.7%
4/6 • Number of events 5
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
30.0%
3/10 • Number of events 7
|
16.7%
1/6 • Number of events 3
|
|
Investigations
PLATELET COUNT DECREASED
|
30.0%
3/10 • Number of events 6
|
100.0%
6/6 • Number of events 14
|
|
Investigations
PROTEIN TOTAL DECREASED
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Investigations
PROTEIN URINE PRESENT
|
20.0%
2/10 • Number of events 2
|
33.3%
2/6 • Number of events 4
|
|
Investigations
RED BLOOD CELLS URINE POSITIVE
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
URINARY SEDIMENT ABNORMAL
|
20.0%
2/10 • Number of events 8
|
0.00%
0/6
|
|
Investigations
URINE BILIRUBIN INCREASED
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Investigations
UROBILIN URINE PRESENT
|
10.0%
1/10 • Number of events 6
|
16.7%
1/6 • Number of events 1
|
|
Investigations
WEIGHT DECREASED
|
60.0%
6/10 • Number of events 7
|
33.3%
2/6 • Number of events 2
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
30.0%
3/10 • Number of events 6
|
16.7%
1/6 • Number of events 1
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
10.0%
1/10 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Investigations
WHITE BLOOD CELLS URINE
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
ANOREXIA
|
90.0%
9/10 • Number of events 45
|
100.0%
6/6 • Number of events 11
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
20.0%
2/10 • Number of events 4
|
16.7%
1/6 • Number of events 2
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
10.0%
1/10 • Number of events 2
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
DIZZINESS
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/10
|
50.0%
3/6 • Number of events 3
|
|
Nervous system disorders
EXTRAPYRAMIDAL DISORDER
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
PYRAMIDAL TRACT SYNDROME
|
0.00%
0/10
|
16.7%
1/6 • Number of events 2
|
|
Nervous system disorders
SOMNOLENCE
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 3
|
|
Psychiatric disorders
INSOMNIA
|
10.0%
1/10 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
20.0%
2/10 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
NAIL BED INFLAMMATION
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
HAEMORRHAGE
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
HYPERTENSION
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER