Trial Outcomes & Findings for A Dose-finding Study of Birabresib (MK-8628) in Participants With Recurrent Glioblastoma Multiforme (MK-8628-002) (NCT NCT02296476)

Last Updated: 2021-01-26

Results Overview

Progression-free survival was the time from the start of study treatment to the date of clinical or radiographic evidence of progressive disease according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria or death. Progression, as assessed by RANO 2010, was defined as a ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. PFS at 6 months was measured as the percentage of participants who were alive and progression-free at Month 6. PFS at 6 months was calculated for all participants who were actively enrolled in the study at the 6-month time point.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Month 6

Results posted on

2021-01-26

Participant Flow

Participants had a confirmed diagnosis of de novo glioblastoma multiforme (World Health Organization grade IV astrocytoma) with tumor recurrence following standard front-line treatment with surgery, cranial radiotherapy and temozolomide. Other inclusion and exclusion criteria applied.

Participant milestones

Participant milestones
Measure	MK-8628 80 mg Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Overall Study STARTED	6	4	2
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	6	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-8628 80 mg Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Overall Study Disease Progression	6	4	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	Total n=12 Participants Total of all reporting groups
Age, Continuous	49.7 Years STANDARD_DEVIATION 14.2 • n=6 Participants	55.8 Years STANDARD_DEVIATION 11.2 • n=4 Participants	54.5 Years STANDARD_DEVIATION 21.9 • n=2 Participants	52.5 Years STANDARD_DEVIATION 13.3 • n=12 Participants
Sex: Female, Male Female	2 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=2 Participants	2 Participants n=12 Participants
Sex: Female, Male Male	4 Participants n=6 Participants	4 Participants n=4 Participants	2 Participants n=2 Participants	10 Participants n=12 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Month 6

Population: All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study magnetic resonance imaging (MRI). Since no participants reached the 6-month time point in the study, PFS at 6 months could not be calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 Months

Population: All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression.

ORR was defined as the number of participants in the analysis population who experienced a Complete Response (CR: complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically) or a Partial Response (PR: ≥50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no new lesions; stable or reduced corticosteroid dose; and stable or improved clinically) and was assessed using RANO 2010.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Objective Response Rate (ORR)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 6 Months

Population: All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. Since no participants experienced a CR or PR, DOR could not be calculated.

DOR was the time from the first documented CR (complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically)or PR (≥50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no new lesions; stable or reduced corticosteroid dose; and stable or improved clinically), as assessed by RANO 2010, until documentation of disease progression, or the date of the last tumor assessment (if there was no documented progression), or the last tumor assessment before the start of further antitumor therapy. DOR was calculated for all participants who experienced a CR or PR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 Months

Population: All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. Since all participants discontinued the study due to disease progression, OS could not be calculated.

OS was the time from the start of study treatment to the date of death. Participants were to be censored at their last contact if they were still alive at the cut-off date. OS was calculated for all participants who did not discontinue from the study due to disease progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 Months

Population: All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression.

Progression-free survival was the time from the start of study treatment to the date of clinical or radiographic evidence of progressive disease according to RANO 2010 criteria or death. Progression, as assessed by RANO 2010, was defined as a ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. PFS was measured as the number of participants who were alive and progression-free for up to 6 months.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Progression-free Survival	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 6 Months

Population: All participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Number of Participants Who Experienced at Least One Adverse Event (AE)	6 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 6 Months

Population: All participants who received at least one dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who experienced ≥1 Grade 3-5 AE per National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03 criteria is presented. Grade 3 was classified as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care; Grade 4 was classified as potentially life-threatening or disabling; and Grade 5 was an AE resulting in death.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Number of Participants Who Experienced at Least One Toxicity Grade 3-5 AE	3 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 6 Months

Population: All participants who received at least one dose of study treatment.

The number of participants who discontinued study treatment due to an AE is presented.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Number of Participants Who Discontinued Study Treatment Due to an AE	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Cycle 1 (Up to 28 days)

Population: All participants who received at least 21 days of the planned dose of study drug during the first 28-day cycle or experienced a DLT.

A DLT was defined as any of the following toxicities that were considered by the investigator to be related to MK-8628: Hematologic toxicity: Grade 4 hematologic toxicity or febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with bleeding or lasting \>7 days; Non-hematologic toxicity: Grade 3 or 4 non-hematologic toxicity (regardless of duration) unless it was not optimally managed with supportive care, Grade 3 or 4 laboratory abnormality lasting \>7 days, or intolerable Grade 2 non-hematologic toxicity resulting in study treatment discontinuation or delay \>7 days with or without dose reduction.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours postdose

Population: All participants who received MK-8628 and had blood samples drawn for PK analyses.

Blood samples were obtained at specified time points for the pharmacokinetic (PK) analysis of Cmax of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Cmax was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Cmax of MK-8628 after oral administration is presented.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Observed Maximum Concentration (Cmax) of MK-8628	1022 μg/Liter Standard Deviation 377	1138 μg/Liter Standard Deviation 527	2725 μg/Liter Standard Deviation NA Standard deviation could not be estimated for 2 participants.

SECONDARY outcome

Timeframe: Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours postdose

Population: All participants who received MK-8628 and had blood samples drawn for PK analyses.

Blood samples were obtained at specified time points for the PK analysis of Tmax of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Tmax was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Tmax of MK-8628 after oral administration is presented.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Time to Maximum Concentration (Tmax) of MK-8628	1.7 hours Standard Deviation 0.498	2.50 hours Standard Deviation 0.572	2.04 hours Standard Deviation NA Standard deviation could not be estimated for 2 participants.

SECONDARY outcome

Timeframe: Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours

Population: All participants who received MK-8628 and had blood samples drawn for PK analyses.

Blood samples were obtained at specified time points for the PK analysis of t1/2 of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and t1/2 was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The t1/2 of MK-8628 after oral administration is presented.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Apparent Terminal Half-Life (t1/2) of MK-8628	3.78 hours Standard Deviation 0.366	3.74 hours Standard Deviation 0.431	3.50 hours Standard Deviation NA Standard deviation could not be estimated for 2 participants.

SECONDARY outcome

Timeframe: Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours

Population: All participants who received MK-8628 and had blood samples drawn for PK analyses.

Blood samples were obtained at specified time points for the PK analysis of Cl/F of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Cl/F was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Cl/F of MK-8628 after oral administration is presented.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Apparent Total Body Clearance (Cl/F) of MK-8628	10.4 Liters/hour Standard Deviation 2.19	13.0 Liters/hour Standard Deviation 4.03	7.75 Liters/hour Standard Deviation NA Standard deviation could not be estimated for 2 participants.

SECONDARY outcome

Timeframe: Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours

Population: All participants who received MK-8628 and had blood samples drawn for PK analyses.

Blood samples were obtained at specified time points for the PK analysis of Vz/F of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Vz/F was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Vz/F of MK-8628 after oral administration is presented.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of MK-8628	56.3 Liters Standard Deviation 9.73	70.3 Liters Standard Deviation 24.1	39.3 Liters Standard Deviation NA Standard deviation could not be estimated for 2 participants.

SECONDARY outcome

Timeframe: Predose on Days 29 and 57

Population: All participants who received MK-8628 and had predose blood samples drawn on Days 29 and 57 for steady state MK-8628 concentration. Participants in the 160 mg dose group were not analyzed for Cmin because they discontinued before Day 29.

Blood samples were obtained at specified time points for the PK analysis of Cmin of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. A single Cmin value for MK-8628 was estimated using dose and steady-state predose concentrations of MK-8628 on Days 29 and 57. The Cmin of MK-8628 after oral administration is presented.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=1 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=3 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Observed Minimum Concentration (Cmin) of MK-8628	85.4 μg/Liter Standard Deviation NA Not calculated on only 1 participant	54.1 μg/Liter Standard Deviation 35.4	—

SECONDARY outcome

Timeframe: Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours

Population: All participants who received MK-8628 and had blood samples drawn for PK analyses.

Blood samples were obtained at specified time points for the PK analysis of AUC 0-∞ of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The AUC 0-∞ was estimated indirectly using the dose and CL/F values. The AUC 0-∞ of MK-8628 after oral administration is presented.

Outcome measures

Outcome measures
Measure	MK-8628 80 mg n=6 Participants Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 Participants Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 Participants Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Area Under the Concentration-time Curve of MK-8628 From Time 0 to Infinity (AUC 0-∞)	8028 μg•hours/Liter Standard Deviation 2083	10200 μg•hours/Liter Standard Deviation 4312	20700 μg•hours/Liter Standard Deviation NA Standard deviation could not be estimated for 2 participants.

Adverse Events

MK-8628 80 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

MK-8628 120 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

MK-8628 160 mg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-8628 80 mg n=6 participants at risk Participants received 80 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 120 mg n=4 participants at risk Participants received 120 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.	MK-8628 160 mg n=2 participants at risk Participants received 160 mg of oral MK-8628 administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Blood and lymphatic system disorders Thrombocytopenia	16.7% 1/6 • Number of events 1 • Up to 6 months (Day 1 through 28 of each treatment cycle for a maximum of 6 treatment cycles) The Safety Population consisted of all participants who received at least one dose of study treatment.	0.00% 0/4 • Up to 6 months (Day 1 through 28 of each treatment cycle for a maximum of 6 treatment cycles) The Safety Population consisted of all participants who received at least one dose of study treatment.	50.0% 1/2 • Number of events 1 • Up to 6 months (Day 1 through 28 of each treatment cycle for a maximum of 6 treatment cycles) The Safety Population consisted of all participants who received at least one dose of study treatment.
Nervous system disorders Intracranial pressure increased	0.00% 0/6 • Up to 6 months (Day 1 through 28 of each treatment cycle for a maximum of 6 treatment cycles) The Safety Population consisted of all participants who received at least one dose of study treatment.	0.00% 0/4 • Up to 6 months (Day 1 through 28 of each treatment cycle for a maximum of 6 treatment cycles) The Safety Population consisted of all participants who received at least one dose of study treatment.	50.0% 1/2 • Number of events 1 • Up to 6 months (Day 1 through 28 of each treatment cycle for a maximum of 6 treatment cycles) The Safety Population consisted of all participants who received at least one dose of study treatment.

Other adverse events

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 The Sponsor has the opportunity to review proposed publications regarding this trial 45 days prior to submission for publication. Publication can be withheld an additional 90 days to allow for filing a patent or taking other measures to establish and preserve proprietary rights. Publication of the results of the study shall be made only as part of a publication of the results obtained by all sites performing the study.
Publication restrictions are in place

Restriction type: OTHER