Trial Outcomes & Findings for Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer (NCT NCT01033032)

Last Updated: 2022-05-03

Results Overview

Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on the study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

78 participants

Primary outcome timeframe

every 6 weeks until progressive disease

Results posted on

2022-05-03

Participant Flow

Patients were recruited at multiple dose levels into the Dose Escalation (Phase I) portion of this study to determine the safest dose of this regime (MTD - Maximum Tolerated Dose). Upon determination of this dose, patients being treated at the MTD proceeded to the Dose Expansion (Phase II) portion of the study and additional patients were recruited

Participant milestones

Participant milestones
Measure	Dose Level 1 Amrubicin - 90 mg/m\^2 by intravenous (IV) every 21 days	Dose Level 2 Amrubicin - 100 mg/m\^2 IV every 21 days	Dose Level 3 Amrubicin - 110 mg/m\^2 IV every 21 days	Dose Level 4 Amrubicin - 120 mg/m\^2 every 21 days	Phase II Amrubicin - 110 mg/m\^2 IV every 21 days
Overall Study STARTED	3	3	3	6	63
Overall Study COMPLETED	0	0	3	0	0
Overall Study NOT COMPLETED	3	3	0	6	63

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I - Dose Level 1 n=3 Participants Amrubicin -90 mg/m\^2 by intravenous(IV) every 21days	Phase I - Dose Level 2 n=3 Participants Amrubicin -100 mg/m\^2 IV every 21days	Phase I - Dose Level 3 n=3 Participants Amrubicin -110 mg/m\^2 IV every 21days	Phase I - Dose Level 4 n=6 Participants Amrubicin -120 mg/m\^2 every 21 days	Phase II - Dose Level 3 n=63 Participants Amrubicin -110 mg/m\^2 IV every 21days	Total n=78 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	44 Participants n=21 Participants	58 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	19 Participants n=21 Participants	20 Participants n=10 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	63 Participants n=21 Participants	78 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	53 Participants n=21 Participants	63 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants	11 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=10 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	53 Participants n=21 Participants	67 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants

PRIMARY outcome

Timeframe: every 6 weeks until progressive disease

Population: Patients who received the dose level 3 MTD dose/Phase II dose (Amrubicin -110 mg/m\^2) are included in the analysis. The 3, dose level 3 phase I pts and 63 phase II pts treated at this dose level are all combined to evaluate the efficacy of the MTD/phase II dose. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure. The other 12 phase I pts who were not treated at the MTD are excluded.

Outcome measures

Outcome measures
Measure	Amrubicin n=66 Participants Systemic therapy with amrubicin	Dose Level 2 Amrubicin -100 mg/m\^2 IV every 21days	Dose Level 3 Amrubicin -110 mg/m\^2 IV every 21days	Dose Level 4 Amrubicin -120 mg/m\^2 IV every 21 days
Progression-Free Survival (PFS) of MTD/Phase II Patients	4.0 months Interval 2.5 to 5.8	—	—	—

SECONDARY outcome

Timeframe: every 6 weeks until treatment discontinuation, up to 43 months

Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).

Outcome measures

Outcome measures
Measure	Amrubicin n=3 Participants Systemic therapy with amrubicin	Dose Level 2 n=3 Participants Amrubicin -100 mg/m\^2 IV every 21days	Dose Level 3 n=66 Participants Amrubicin -110 mg/m\^2 IV every 21days	Dose Level 4 n=6 Participants Amrubicin -120 mg/m\^2 IV every 21 days
Number of Patients With Adverse Events as a Measure of Safety and Tolerability	3 Participants	3 Participants	65 Participants	6 Participants

SECONDARY outcome

Timeframe: every 6 weeks until treatment discontinuation, up to 43 months

Measured from Day 1 of study drug administration to date of death due to any cause. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to this outcome measure.

Outcome measures

Outcome measures
Measure	Amrubicin n=66 Participants Systemic therapy with amrubicin	Dose Level 2 Amrubicin -100 mg/m\^2 IV every 21days	Dose Level 3 Amrubicin -110 mg/m\^2 IV every 21days	Dose Level 4 Amrubicin -120 mg/m\^2 IV every 21 days
Overall Survival (OS) of MTD/Phase II Patients	14.4 months Interval 10.1 to 18.5	—	—	—

SECONDARY outcome

Timeframe: every 6 weeks until treatment discontinuation, up to 43 months

The number of patients with observed complete response \[CR\] or partial response \[PR\]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.

Outcome measures

Outcome measures
Measure	Amrubicin n=66 Participants Systemic therapy with amrubicin	Dose Level 2 Amrubicin -100 mg/m\^2 IV every 21days	Dose Level 3 Amrubicin -110 mg/m\^2 IV every 21days	Dose Level 4 Amrubicin -120 mg/m\^2 IV every 21 days
Overall Response Rate (ORR)	12 participants	—	—	—

Adverse Events

Dose Level 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Level 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Level 3 (MTD)/Phase II

Serious events: 5 serious events

Other events: 65 other events

Deaths: 0 deaths

Dose Level 4

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1 n=3 participants at risk Amrubicin - 90 mg/m\^2 by intravenous (IV) every 21 days	Dose Level 2 n=3 participants at risk Amrubicin - 100 mg/m\^2 by intravenous (IV) every 21 days	Dose Level 3 (MTD)/Phase II n=66 participants at risk Amrubicin - 110 mg/m\^2 by intravenous (IV) every 21 days Includes patients treated at the MTD in Dose Level 3 phase 1 and in phase II	Dose Level 4 n=6 participants at risk Amrubicin - 120 mg/m\^2 by intravenous (IV) every 21 days
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	1.5% 1/66 • Number of events 1 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
General disorders CHEST PAIN	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	1.5% 1/66 • Number of events 1 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	1.5% 1/66 • Number of events 1 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	1.5% 1/66 • Number of events 1 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Blood and lymphatic system disorders LYMPH NODE PAIN	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	1.5% 1/66 • Number of events 1 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	33.3% 1/3 • Number of events 1 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	1.5% 1/66 • Number of events 1 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	1.5% 1/66 • Number of events 1 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Blood and lymphatic system disorders NEUTROPHIL COUNT DECREASED	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/66 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	1.5% 1/66 • Number of events 2 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Respiratory, thoracic and mediastinal disorders PULMONARY INFILTERATES	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/66 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • every 3 weeks up to 43 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Other adverse events

Additional Information

John D. Hainsworth, MD

Sarah Cannon Research Institute

Phone: 1-877-691-7274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from the date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish results until 18 mos. after the trial has been completed at all sites.
Publication restrictions are in place

Restriction type: OTHER