Trial Outcomes & Findings for Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT02312245)
NCT ID: NCT02312245
Last Updated: 2024-12-05
Results Overview
Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact Binomial method. The primary analysis will pool across all patients, and tumor response rate by treatment arm will also be looked at in an exploratory fashion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
24 weeks
Results posted on
2024-12-05
Participant Flow
Participant milestones
| Measure |
Arm A (Avatar-directed Paclitaxel)
Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity\> \> Bevacizumab: Given IV\>
\> Paclitaxel: Given IV
|
Arm B (Avatar-directed Gemcitabine Hydrochloride)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\> Gemcitabine Hydrochloride: Given IV
|
Arm C (Avatar-directed Liposomal Doxorubicin)
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Bevacizumab: Given IV\>
\> Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
|
Arm D (Avatar-directed Topotecan Hydrochloride)
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.\> \> Bevacizumab: Given IV\>
\> Topotecan Hydrochloride: Given IV
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
0
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
9
|
Reasons for withdrawal
| Measure |
Arm A (Avatar-directed Paclitaxel)
Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity\> \> Bevacizumab: Given IV\>
\> Paclitaxel: Given IV
|
Arm B (Avatar-directed Gemcitabine Hydrochloride)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\> Gemcitabine Hydrochloride: Given IV
|
Arm C (Avatar-directed Liposomal Doxorubicin)
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Bevacizumab: Given IV\>
\> Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
|
Arm D (Avatar-directed Topotecan Hydrochloride)
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.\> \> Bevacizumab: Given IV\>
\> Topotecan Hydrochloride: Given IV
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
2
|
|
Overall Study
Alternative Therapy
|
1
|
0
|
0
|
0
|
|
Overall Study
Progression
|
0
|
0
|
0
|
5
|
|
Overall Study
Patient went to hospice
|
0
|
0
|
0
|
1
|
|
Overall Study
Ineligible
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Avatar-directed Paclitaxel)
n=3 Participants
Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity\> \> Bevacizumab: Given IV\>
\> Paclitaxel: Given IV
|
Arm B (Avatar-directed Gemcitabine Hydrochloride)
n=1 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>
\> Gemcitabine Hydrochloride: Given IV
|
Arm C (Avatar-directed Liposomal Doxorubicin)
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Bevacizumab: Given IV\>
\> Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
|
Arm D (Avatar-directed Topotecan Hydrochloride)
n=9 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.\> \> Bevacizumab: Given IV\>
\> Topotecan Hydrochloride: Given IV
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 8.54 • n=5 Participants
|
32 years
STANDARD_DEVIATION NA • n=7 Participants
|
—
|
56.6 years
STANDARD_DEVIATION 8.22 • n=4 Participants
|
55.7 years
STANDARD_DEVIATION 10.56 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
9 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
9 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
—
|
9 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Tumor Histology Type
Ovarian (serous)
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Tumor Histology Type
Fallopian tube (serous)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Tumor Histology Type
Ovarian (other)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All patients that were eligible and began treatment were analyzed
Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact Binomial method. The primary analysis will pool across all patients, and tumor response rate by treatment arm will also be looked at in an exploratory fashion.
Outcome measures
| Measure |
Arm A (Avatar-directed Paclitaxel)
n=2 Participants
Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity \>
\> Bevacizumab: Given IV
\>
\> Paclitaxel: Given IV
|
Arm B (Avatar-directed Gemcitabine Hydrochloride)
n=1 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Gemcitabine Hydrochloride: Given IV
|
Arm D (Avatar-directed Topotecan Hydrochloride)
n=9 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Bevacizumab: Given IV
\>
\> Topotecan Hydrochloride: Given IV
|
|---|---|---|---|
|
Percentage of Patients With a Confirmed Tumor Response, Defined as Complete Response or Partial Response Estimated Using Response Evaluation Criteria in Solid Tumors 1.1 Criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: All patients that were eligible and began treatment were analyzed
Maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns.
Outcome measures
| Measure |
Arm A (Avatar-directed Paclitaxel)
n=2 Participants
Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity \>
\> Bevacizumab: Given IV
\>
\> Paclitaxel: Given IV
|
Arm B (Avatar-directed Gemcitabine Hydrochloride)
n=1 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Gemcitabine Hydrochloride: Given IV
|
Arm D (Avatar-directed Topotecan Hydrochloride)
n=9 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Bevacizumab: Given IV
\>
\> Topotecan Hydrochloride: Given IV
|
|---|---|---|---|
|
Number of Patients Experiencing Grade 3+ Adverse Events (AE)
|
1 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 25 monthsPopulation: All patients that were eligible and began treatment were analyzed
OS will be estimated using the method of Kaplan-Meier. Analysis will be conducted with all arms of Avatar-directed chemotherapy pooled.
Outcome measures
| Measure |
Arm A (Avatar-directed Paclitaxel)
n=2 Participants
Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity \>
\> Bevacizumab: Given IV
\>
\> Paclitaxel: Given IV
|
Arm B (Avatar-directed Gemcitabine Hydrochloride)
n=1 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Gemcitabine Hydrochloride: Given IV
|
Arm D (Avatar-directed Topotecan Hydrochloride)
n=9 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Bevacizumab: Given IV
\>
\> Topotecan Hydrochloride: Given IV
|
|---|---|---|---|
|
Overall Survival (OS)
|
7.9 months
The confidence interval was not able to be estimated due to a low number of events
|
8.7 months
The confidence interval was not able to be estimated due to a low number of events
|
9.2 months
Interval 4.5 to
The upper limit of the confidence interval was not able to be estimated due to a low number of events
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: All patients that were eligible and began treatment were analyzed
PFS will be estimated using the method of Kaplan-Meier. Analysis will be conducted with all arms of Avatar-directed chemotherapy pooled.
Outcome measures
| Measure |
Arm A (Avatar-directed Paclitaxel)
n=2 Participants
Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity \>
\> Bevacizumab: Given IV
\>
\> Paclitaxel: Given IV
|
Arm B (Avatar-directed Gemcitabine Hydrochloride)
n=1 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Gemcitabine Hydrochloride: Given IV
|
Arm D (Avatar-directed Topotecan Hydrochloride)
n=9 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Bevacizumab: Given IV
\>
\> Topotecan Hydrochloride: Given IV
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
7.9 months
The confidence interval was not able to be estimated due to a low number of events
|
8.7 months
The confidence interval was not able to be estimated due to a low number of events
|
3.0 months
Interval 1.9 to
The upper limit of the confidence interval was not able to be estimated due to a low number of events
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: All patients that were eligible and began treatment were analyzed
The Chi-square or Fisher's Exact test will be used to compare the response rates between patients who did or did not receive bevacizumab treatment. The response rates will also be reported by treatment type.
Outcome measures
| Measure |
Arm A (Avatar-directed Paclitaxel)
n=2 Participants
Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity \>
\> Bevacizumab: Given IV
\>
\> Paclitaxel: Given IV
|
Arm B (Avatar-directed Gemcitabine Hydrochloride)
n=1 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Gemcitabine Hydrochloride: Given IV
|
Arm D (Avatar-directed Topotecan Hydrochloride)
n=9 Participants
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Bevacizumab: Given IV
\>
\> Topotecan Hydrochloride: Given IV
|
|---|---|---|---|
|
Number of Patients With a Partial or Confirmed Response
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsThis will be an exploratory analysis that will use the outcome data from this trial to inform future work using Avatar directed therapy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsOverall concordance rate and confidence interval will be reported.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Avatar-directed Paclitaxel)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm B (Avatar-directed Gemcitabine Hydrochloride)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm D (Avatar-directed Topotecan Hydrochloride)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm A (Avatar-directed Paclitaxel)
n=2 participants at risk
Paclitaxel: Given IV
|
Arm B (Avatar-directed Gemcitabine Hydrochloride)
n=1 participants at risk
Gemcitabine Hydrochloride: Given IV
|
Arm D (Avatar-directed Topotecan Hydrochloride)
n=9 participants at risk
Topotecan Hydrochloride: Given IV
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • 25 months
|
0.00%
0/1 • 25 months
|
0.00%
0/9 • 25 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/2 • 25 months
|
0.00%
0/1 • 25 months
|
11.1%
1/9 • Number of events 1 • 25 months
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/2 • 25 months
|
0.00%
0/1 • 25 months
|
11.1%
1/9 • Number of events 1 • 25 months
|
|
Infections and infestations
Skin infection
|
50.0%
1/2 • Number of events 1 • 25 months
|
0.00%
0/1 • 25 months
|
0.00%
0/9 • 25 months
|
|
Investigations
Creatinine increased
|
0.00%
0/2 • 25 months
|
0.00%
0/1 • 25 months
|
11.1%
1/9 • Number of events 1 • 25 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • 25 months
|
0.00%
0/1 • 25 months
|
0.00%
0/9 • 25 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2 • 25 months
|
0.00%
0/1 • 25 months
|
11.1%
1/9 • Number of events 1 • 25 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/2 • 25 months
|
0.00%
0/1 • 25 months
|
11.1%
1/9 • Number of events 1 • 25 months
|
|
Psychiatric disorders
Confusion
|
50.0%
1/2 • Number of events 1 • 25 months
|
0.00%
0/1 • 25 months
|
0.00%
0/9 • 25 months
|
Other adverse events
| Measure |
Arm A (Avatar-directed Paclitaxel)
n=2 participants at risk
Paclitaxel: Given IV
|
Arm B (Avatar-directed Gemcitabine Hydrochloride)
n=1 participants at risk
Gemcitabine Hydrochloride: Given IV
|
Arm D (Avatar-directed Topotecan Hydrochloride)
n=9 participants at risk
Topotecan Hydrochloride: Given IV
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • 25 months
|
0.00%
0/1 • 25 months
|
22.2%
2/9 • Number of events 2 • 25 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • 25 months
|
0.00%
0/1 • 25 months
|
11.1%
1/9 • Number of events 1 • 25 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • 25 months
|
0.00%
0/1 • 25 months
|
22.2%
2/9 • Number of events 2 • 25 months
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • 25 months
|
0.00%
0/1 • 25 months
|
11.1%
1/9 • Number of events 1 • 25 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/2 • 25 months
|
0.00%
0/1 • 25 months
|
11.1%
1/9 • Number of events 1 • 25 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • 25 months
|
0.00%
0/1 • 25 months
|
11.1%
1/9 • Number of events 1 • 25 months
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 2 • 25 months
|
100.0%
1/1 • Number of events 1 • 25 months
|
0.00%
0/9 • 25 months
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Number of events 1 • 25 months
|
0.00%
0/1 • 25 months
|
0.00%
0/9 • 25 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2 • Number of events 1 • 25 months
|
0.00%
0/1 • 25 months
|
11.1%
1/9 • Number of events 3 • 25 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place