Trial Outcomes & Findings for Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer (NCT NCT04504331)
NCT ID: NCT04504331
Last Updated: 2026-02-12
Results Overview
The primary outcome for this study is dose-limiting toxicities (DLTs) during the first 2 cycles of therapy. All grades per the Common Terminology Criteria for Adverse Events (CTCAE). DLT is defined as a related and clinically significant adverse event (AE), including missed doses due to a related AE.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
4 participants
Primary outcome timeframe
8 weeks
Results posted on
2026-02-12
Participant Flow
Enrollment was closed before any participants were enrolled in Cohort 3 (Infigratinib (75 mg) + Tamoxifen).
Participant milestones
| Measure |
Cohort 1: Infigratinib (100mg) + Tamoxifen
In study part 1 (dose exploration), participants receive infigratinib up to 100 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
|
Cohort 2: Infigratinib (125mg) + Tamoxifen
In study part 1 (dose exploration), participants receive infigratinib up to 125 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen
|
Cohort 3: Infigratinib (75mg) + Tamoxifen
In study part 1 (dose exploration), participants receive infigratinib up to 75 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
|
|---|---|---|---|
|
Dose Level 1 (up to 18 28-day Cycles+FU)
STARTED
|
3
|
0
|
0
|
|
Dose Level 1 (up to 18 28-day Cycles+FU)
Completed at Least 6 Treatment Cycles
|
3
|
0
|
0
|
|
Dose Level 1 (up to 18 28-day Cycles+FU)
COMPLETED
|
3
|
0
|
0
|
|
Dose Level 1 (up to 18 28-day Cycles+FU)
NOT COMPLETED
|
0
|
0
|
0
|
|
Dose Level 2 (up to 18 28-day Cycles+FU)
STARTED
|
0
|
1
|
0
|
|
Dose Level 2 (up to 18 28-day Cycles+FU)
Completed at Least 6 Treatment Cycles
|
0
|
0
|
0
|
|
Dose Level 2 (up to 18 28-day Cycles+FU)
COMPLETED
|
0
|
1
|
0
|
|
Dose Level 2 (up to 18 28-day Cycles+FU)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1: Infigratinib (100mg) + Tamoxifen
n=3 Participants
In study part 1 (dose exploration), participants receive infigratinib up to 100 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
|
Cohort 2: Infigratinib (125mg) + Tamoxifen
n=1 Participants
In study part 1 (dose exploration), participants receive infigratinib up to 125 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 9.6 • n=41 Participants
|
38.5 years
STANDARD_DEVIATION NA • n=1581 Participants
|
53.9 years
STANDARD_DEVIATION 13.0 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: 8 weeksThe primary outcome for this study is dose-limiting toxicities (DLTs) during the first 2 cycles of therapy. All grades per the Common Terminology Criteria for Adverse Events (CTCAE). DLT is defined as a related and clinically significant adverse event (AE), including missed doses due to a related AE.
Outcome measures
| Measure |
Cohort 1: Infigratinib (100mg) + Tamoxifen
n=3 Participants
In study part 1 (dose exploration), participants receive infigratinib up to 100 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
|
Cohort 2: Infigratinib (125mg) + Tamoxifen
n=1 Participants
In study part 1 (dose exploration), participants receive infigratinib up to 125 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen
|
|---|---|---|
|
Number of Dose-limiting Toxicities (DLTs)
|
0 DLTs
|
0 DLTs
|
SECONDARY outcome
Timeframe: From first dose to 30 days after the last dose of study drug (up to 94 days)Treatment emergent adverse events (TEAEs) are defined as adverse events of any grade with initial onset or increasing in severity after the first dose of study treatment until 30 days after last dose of study drug. Pregnancy during the reporting period will be classified as a serious adverse event.
Outcome measures
| Measure |
Cohort 1: Infigratinib (100mg) + Tamoxifen
n=3 Participants
In study part 1 (dose exploration), participants receive infigratinib up to 100 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
|
Cohort 2: Infigratinib (125mg) + Tamoxifen
n=1 Participants
In study part 1 (dose exploration), participants receive infigratinib up to 125 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAE)
|
49 adverse events
|
26 adverse events
|
SECONDARY outcome
Timeframe: From enrollment to day of scan (up to 64 days)Objective tumor response will be assessed as achieving a Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Complete Response (CR) or a Partial Response (PR). The outcome will be reported as the number of subjects that achieve an overall response (OR) to treatment, ie, CR or PR, within 18 months of starting treatment. RECIST criteria are: * CR = Disappearance of all target lesions * PR = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
Outcome measures
| Measure |
Cohort 1: Infigratinib (100mg) + Tamoxifen
n=3 Participants
In study part 1 (dose exploration), participants receive infigratinib up to 100 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
|
Cohort 2: Infigratinib (125mg) + Tamoxifen
n=1 Participants
In study part 1 (dose exploration), participants receive infigratinib up to 125 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen
|
|---|---|---|
|
Objective Tumor Response Rate
CR
|
0 Participants
|
0 Participants
|
|
Objective Tumor Response Rate
OR (CR + PR)
|
0 Participants
|
0 Participants
|
|
Objective Tumor Response Rate
PR
|
0 Participants
|
0 Participants
|
|
Objective Tumor Response Rate
PD
|
3 Participants
|
0 Participants
|
|
Objective Tumor Response Rate
SD
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 9 monthsProgression free survival (PFS) means the participant remains alive without return or relapse of the tumor. The outcome is defined as the number of days to either progressive disease as defined per RECIST v1.1 or death. RECIST criteria are: * CR = Disappearance of all target lesions * PR = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
Outcome measures
| Measure |
Cohort 1: Infigratinib (100mg) + Tamoxifen
n=3 Participants
In study part 1 (dose exploration), participants receive infigratinib up to 100 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
|
Cohort 2: Infigratinib (125mg) + Tamoxifen
n=1 Participants
In study part 1 (dose exploration), participants receive infigratinib up to 125 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen
|
|---|---|---|
|
Progression-free Survival (PFS)
|
61 days
Standard Deviation 5.3
|
NA days
Not evaluable due to insufficient number of events
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who completed at least 6 treatment cycles are included in the analysis.
Clinical benefit (CB) is defined as achieving a Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Complete Response (CR) ; Partial Response (PR); or Stable Disease (SD). The outcome will be reported as the number of subjects that achieve CR, PR, or SD. RECIST criteria are: * CR = Disappearance of all target lesions * PR = ≥ 30% decrease in the sum of the longest diameter of target lesions * SD = Small changes that do not meet any of the above criteria * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
Outcome measures
| Measure |
Cohort 1: Infigratinib (100mg) + Tamoxifen
n=3 Participants
In study part 1 (dose exploration), participants receive infigratinib up to 100 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
|
Cohort 2: Infigratinib (125mg) + Tamoxifen
In study part 1 (dose exploration), participants receive infigratinib up to 125 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen
|
|---|---|---|
|
Clinical Benefit Rate
CR
|
0 Participants
|
—
|
|
Clinical Benefit Rate
PR
|
0 Participants
|
—
|
|
Clinical Benefit Rate
SD
|
0 Participants
|
—
|
|
Clinical Benefit Rate
CB (CR + PR +SD)
|
0 Participants
|
—
|
|
Clinical Benefit Rate
PD
|
3 Participants
|
—
|
Adverse Events
Cohort 1: Infigratinib (100mg) + Tamoxifen
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Infigratinib (125mg) + Tamoxifen
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Infigratinib (100mg) + Tamoxifen
n=3 participants at risk
In study part 1 (dose exploration), participants receive infigratinib up to 100 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
|
Cohort 2: Infigratinib (125mg) + Tamoxifen
n=1 participants at risk
In study part 1 (dose exploration), participants receive infigratinib up to 125 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen
|
|---|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
Other adverse events
| Measure |
Cohort 1: Infigratinib (100mg) + Tamoxifen
n=3 participants at risk
In study part 1 (dose exploration), participants receive infigratinib up to 100 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
|
Cohort 2: Infigratinib (125mg) + Tamoxifen
n=1 participants at risk
In study part 1 (dose exploration), participants receive infigratinib up to 125 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract pain
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dry nose
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Reproductive system and breast disorders
Other - pulling sensation in uterus
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Reproductive system and breast disorders
Other - yeast infection
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Skin and subcutaneous tissue disorders
Contusion
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Skin and subcutaneous tissue disorders
Flushing
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Skin and subcutaneous tissue disorders
Other - Eyelash thickening
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Vascular disorders
Cerebrovascular accident
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Vascular disorders
Contusion
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Vascular disorders
Hematoma
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Vascular disorders
Retinopathy
|
33.3%
1/3 • Number of events 2 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hypophosphtaemia
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Chills
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Contusion
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Nervous system disorders
Vision blurred
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Psychiatric disorders
Irritability
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia of lower extremities
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Nervous system disorders
Cerebrovascular accident
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Nervous system disorders
Muscular weakness
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
100.0%
3/3 • Number of events 4 • Up to 9 months
|
100.0%
1/1 • Number of events 3 • Up to 9 months
|
|
Cardiac disorders
Atrial tachycardia
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Eye disorders
Retinopathy
|
33.3%
1/3 • Number of events 2 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Eye disorders
Dry Eye
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Eye disorders
Other - corneal endothelial cell count decreased
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Gastrointestinal disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
General disorders
Flushing
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
General disorders
Irritability
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
General disorders
Pain
|
66.7%
2/3 • Number of events 6 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 2 • Up to 9 months
|
|
Immune system disorders
Immune system disorder
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Number of events 1 • Up to 9 months
|
0.00%
0/1 • Up to 9 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 9 months
|
100.0%
1/1 • Number of events 1 • Up to 9 months
|
Additional Information
Jennifer Lee Caswell-Jin, MD
Stanford Medicine at Stanford University
Phone: 1-310-332-6541
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place