Trial Outcomes & Findings for Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer (NCT NCT03992456)
NCT ID: NCT03992456
Last Updated: 2024-05-21
Results Overview
OS is defined as the Time from randomization to death from any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier. Overall survival will be compared between the 2 treatment arms using the un-stratified log-rank test will be used.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
2 years
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
Arm A (Panitumumab)
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Panitumumab: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride)
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.\> \> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies\>
\> Regorafenib: Given PO\>
\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Arm A (Panitumumab)
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Panitumumab: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride)
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.\> \> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies\>
\> Regorafenib: Given PO\>
\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Disease progression
|
4
|
5
|
|
Overall Study
Emergency surgery unrelated to treatment
|
0
|
1
|
Baseline Characteristics
Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Panitumumab)
n=5 Participants
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.\>
\> Panitumumab: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride)
n=6 Participants
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.\> \> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies\>
\> Regorafenib: Given PO\>
\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 11.17 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 6.75 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 8.64 • 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
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.7 kg/m^2
STANDARD_DEVIATION 8.82 • n=5 Participants
|
24.1 kg/m^2
STANDARD_DEVIATION 4.57 • n=7 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 6.72 • n=5 Participants
|
|
Primary Tumor Site
Left
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Primary Tumor Site
Right
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOS is defined as the Time from randomization to death from any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier. Overall survival will be compared between the 2 treatment arms using the un-stratified log-rank test will be used.
Outcome measures
| Measure |
Arm A (Panitumumab)
n=5 Participants
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\> Panitumumab: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride)
n=6 Participants
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
\>
\> Regorafenib: Given PO
\>
\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
|---|---|---|
|
Overall Survival (OS)
|
7.5 months
Interval 7.2 to
Due to an insufficient number of participants with events, the upper confidence interval was not able to be estimated
|
8.3 months
Interval 4.9 to
Due to an insufficient number of participants with events, the upper confidence interval was not able to be estimated
|
SECONDARY outcome
Timeframe: 1 yearPFS is defined as the time from randomization to documentation of disease progression or death due to any cause, whichever is first. If the patient did not have any disease evaluation post randomization, PFS will be censored at one day after randomization. The distribution of progression free survival will be estimated using the method of Kaplan-Meier. Progression free survival will be compared between the 2 treatment arms using the log-rank test which is used for the primary endpoint analysis.
Outcome measures
| Measure |
Arm A (Panitumumab)
n=5 Participants
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\> Panitumumab: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride)
n=6 Participants
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
\>
\> Regorafenib: Given PO
\>
\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
|---|---|---|
|
Progression Free Survival (PFS)
|
5.1 months
Interval 2.0 to
Due to an insufficient number of participants with events, the upper confidence interval was not able to be estimated
|
3.7 months
Interval 2.0 to
Due to an insufficient number of participants with events, the upper confidence interval was not able to be estimated
|
SECONDARY outcome
Timeframe: 2 yearsDefined as the number of patients with a complete response (CR) or partial response (PR) (as defined by the Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) divided by the number of evaluable patients in each arm. ORR will be compared between the 2 treatment arms. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson.
Outcome measures
| Measure |
Arm A (Panitumumab)
n=5 Participants
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\> Panitumumab: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride)
n=6 Participants
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
\>
\> Regorafenib: Given PO
\>
\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
|---|---|---|
|
Overall Response Rate (ORR)
|
20.0 percent
Interval 0.51 to 71.6
|
0.0 percent
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: 4 monthsDefined as the number of patients with a complete response (CR), partial response (PR), or stable disease for \>= 4 months (as defined by the RECIST 1.1) divided by the number of evaluable patients in each arm. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson.
Outcome measures
| Measure |
Arm A (Panitumumab)
n=5 Participants
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\> Panitumumab: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride)
n=6 Participants
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
\>
\> Regorafenib: Given PO
\>
\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
|---|---|---|
|
Clinical Benefit Rate
|
20.0 percent
Interval 0.51 to 71.6
|
16.67 percent
Interval 0.42 to 64.12
|
SECONDARY outcome
Timeframe: 2 yearsThe maximum grade for each type of adverse event will be recorded for each patient in each cycle. The number of patients experiencing grade 3 or higher adverse events will be compared using Chi-Square or Fisher's Exact tests.
Outcome measures
| Measure |
Arm A (Panitumumab)
n=5 Participants
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\> Panitumumab: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride)
n=6 Participants
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
\>
\> Regorafenib: Given PO
\>
\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
|---|---|---|
|
Incidence of Adverse Events
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: This analysis was not conducted due to no patient response rates.
Patients reported quality of life (QOL) outcomes will be collected using the Linear Analog Self-Assessment (LASA) Questionnaire. Data will be collected each cycle. Mean values of the first question (regarding overall QOL) at each cycle will be plotted, and stratified by arm. Additional analyses using data collected from the LASA questionnaire may be performed. Score from 0-10, 0 is worse and 10 is better.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, at restaging, and at disease progressionA report will be generated for each clinical specimen, which may include (but not limited to) the presence or absence of relevant gene mutations or amplifications, along with the allele frequency. Mutations of interest include KRAS and NRAS exons 2, 3, and 4, BRAF, PIK3CA, EGFR, AKT, PTEN, MAP2K1, and MET. Amplifications of interest include MET, EGFR, KRAS, and ERBB2. Genes and alterations analyzed will be based on best available science at the time of analysis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPlasma samples will be analyzed for multiple soluble protein analytes, which may include (but not limited to) HGF, c-MET, EGF, HBEGF, TGF-alpha, EGFR, HER2, and CD73.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsComprehensive mutational analysis will be performed on archived formalin fixed paraffin embedded (FFPE) tumor samples. This analysis may include, but is not limited to Next Generation Sequencing (NGS) and IHC where appropriate.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Panitumumab)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 5 deaths
Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Arm A (Panitumumab)
n=5 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride)
n=6 participants at risk
Trifluridine and Tipiracil Hydrochloride: Given PO
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Arm A (Panitumumab)
n=5 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride)
n=6 participants at risk
Trifluridine and Tipiracil Hydrochloride: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Ascites
|
20.0%
1/5 • Number of events 1 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
3/5 • Number of events 6 • 2 years
|
33.3%
2/6 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
Fatigue
|
60.0%
3/5 • Number of events 12 • 2 years
|
66.7%
4/6 • Number of events 12 • 2 years
|
|
Infections and infestations
Paronychia
|
20.0%
1/5 • Number of events 1 • 2 years
|
0.00%
0/6 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • 2 years
|
33.3%
2/6 • Number of events 3 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • 2 years
|
33.3%
2/6 • Number of events 2 • 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • 2 years
|
50.0%
3/6 • Number of events 3 • 2 years
|
|
Investigations
Weight loss
|
0.00%
0/5 • 2 years
|
33.3%
2/6 • Number of events 3 • 2 years
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/5 • 2 years
|
33.3%
2/6 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • Number of events 1 • 2 years
|
0.00%
0/6 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
40.0%
2/5 • Number of events 4 • 2 years
|
0.00%
0/6 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff injury
|
20.0%
1/5 • Number of events 1 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 2 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
0.00%
0/5 • 2 years
|
33.3%
2/6 • Number of events 4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
100.0%
5/5 • Number of events 17 • 2 years
|
16.7%
1/6 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.00%
0/5 • 2 years
|
16.7%
1/6 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place