Trial Outcomes & Findings for Dose-Finding, Safety and Efficacy Study of RX-0201 Plus Everolimus in Metastatic Renal Cell Cancer (NCT NCT02089334)

NCT ID: NCT02089334

Last Updated: 2020-06-30

Results Overview

Incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

after 1 cycle (3 weeks) of treatment with RX-0201 and everolimus

Results posted on

2020-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	125 mg/m^2/Day RX-0201 + Everolimus (Stage 1) RX-0201 was administered as 125 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	200 mg/m^2/Day RX-0201 + Everolimus (Stage 1) RX-0201 was administered as 200 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	250 mg/m^2/Day RX-0201 + Everolimus (Stage 2) RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of the maximum tolerated dose in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days
Overall Study STARTED	3	4	4	13
Overall Study Received Study Drug	3	4	3	11
Overall Study COMPLETED	3	4	3	6
Overall Study NOT COMPLETED	0	0	1	7

Reasons for withdrawal

Reasons for withdrawal
Measure	250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	250 mg/m^2/Day RX-0201 + Everolimus (Stage 2) RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of the maximum tolerated dose in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days
Overall Study Withdrawal by Subject	0	2
Overall Study Adverse Event	0	2
Overall Study Progressive disease	0	2
Overall Study Physician Decision	1	1

Baseline Characteristics

Dose-Finding, Safety and Efficacy Study of RX-0201 Plus Everolimus in Metastatic Renal Cell Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	125 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=3 Participants RX-0201 was administered as 125 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	200 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=4 Participants RX-0201 was administered as 200 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=3 Participants RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	250 mg/m^2/Day RX-0201 + Everolimus (Stage 2) n=11 Participants RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after the determination of MTD in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	Total n=21 Participants Total of all reporting groups
Age, Continuous	62.7 years STANDARD_DEVIATION 10.79 • n=5 Participants	62.0 years STANDARD_DEVIATION 12.83 • n=7 Participants	61.0 years STANDARD_DEVIATION 15.87 • n=5 Participants	63.9 years STANDARD_DEVIATION 6.30 • n=4 Participants	62.8 years STANDARD_DEVIATION 7.87 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	14 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants	18 Participants n=21 Participants
Ethnicity (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	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants	14 Participants n=21 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
ECOG ECOG = 0	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants
ECOG ECOG = 1	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	11 Participants n=21 Participants
ECOG ECOG = 2	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: after 1 cycle (3 weeks) of treatment with RX-0201 and everolimus

Population: DLTs were only applicable to Stage 1.

Incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities

Outcome measures

Outcome measures
Measure	125 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=3 Participants RX-0201 was administered as 125 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	200 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=4 Participants RX-0201 was administered as 200 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=3 Participants RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	RX-0201 Plus Everolimus (Stage 2) RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of MTD in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days
Incidence of Dose-limiting Toxicities (DLTs) (Stage 1)	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 4 months of treatment with RX-0201 and everolimus

Population: Progression Free Survival (PFS) was determined only in the Stage 2 population.

Median PFS. Progression determined by RECIST v1.1

Outcome measures

Outcome measures
Measure	125 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=11 Participants RX-0201 was administered as 125 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	200 mg/m^2/Day RX-0201 + Everolimus (Stage 1) RX-0201 was administered as 200 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	RX-0201 Plus Everolimus (Stage 2) RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of MTD in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days
Progression Free Survival (Stage 2)	NA days Standard Deviation NA Due to the small numbers of participants enrolled, median PFS could not be calculated.	—	—	—

SECONDARY outcome

Timeframe: predose, 1, 2, 3, 4, 6, and 24 hours after start of Cycle 1 RX-0201 infusion, and then immediately prior to the end of Cycle 1 infusion (Day 15), 1, 2, 3, 4, 6, and 24 hours after infusion is stopped

Population: Stage 1 subjects who had sufficient PK samples for analysis

Css of RX-0201 at the beginning and end of the 14 day continuous infusion

Outcome measures

Outcome measures
Measure	125 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=2 Participants RX-0201 was administered as 125 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	200 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=1 Participants RX-0201 was administered as 200 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=1 Participants RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	RX-0201 Plus Everolimus (Stage 2) RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of MTD in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days
Steady State Concentration (Css) of RX-0201 (Stage 1)	1626 ng/ml Standard Deviation 1107.2	3283 ng/ml Standard Deviation NA Only 1 subject was analyzed due to poor data quality and missing samples	5147 ng/ml Standard Deviation NA Only 1 subject was analyzed due to poor data quality and missing samples	—

SECONDARY outcome

Timeframe: up to 24 weeks of treatment with RX-0201 plus everolimus and at least 30 days of safety follow up

safety of RX-0201 was evaluated through reporting using the grading system in the CTCAE version 4.03 for adverse events and laboratory abnormalities. All statistical methods for safety were descriptive in nature.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and at weeks 6, 12, 18, and 24

Population: All enrolled subjects with subjects analyzed according to the treatment assigned at enrollment/ randomization.

Best overall response as determined by RECIST v1.1. Not Evaluable included the subjects who had completed at least one treatment cycle but no overall response evaluation. Not Done included the subjects who dropped out from the study without completing any treatment cycle and overall response evaluation. The best overall response for each subject from all post-baseline time point overall responses was used. The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence, or occurrence of intolerable toxicity, whatever came first.

Outcome measures

Outcome measures
Measure	125 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=3 Participants RX-0201 was administered as 125 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	200 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=4 Participants RX-0201 was administered as 200 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=4 Participants RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	RX-0201 Plus Everolimus (Stage 2) n=11 Participants RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of MTD in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days
Best Overall Response as Determined by RECIST v1.1. Not Done (ND)	1 Participants	1 Participants	2 Participants	3 Participants
Best Overall Response as Determined by RECIST v1.1. Not Evaluable (NE)	0 Participants	0 Participants	1 Participants	0 Participants
Best Overall Response as Determined by RECIST v1.1. Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response as Determined by RECIST v1.1. Partial Response (PR)	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response as Determined by RECIST v1.1. Stable Disease (SD)	2 Participants	1 Participants	1 Participants	7 Participants
Best Overall Response as Determined by RECIST v1.1. Progressive Disease (PD)	0 Participants	2 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and at weeks 6, 12, 18, and 24

Exploratory analysis of AKT pathway biomarkers, tumor apoptosis biomarkers and other biomarkers in blood or tumor samples

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: After 2 weeks of treatment

Exploratory analysis of plasma concentrations of RX-0201 at the end of infusion

Outcome measures

Outcome data not reported

Adverse Events

125 mg/m^2/Day RX-0201 + Everolimus (Stage 1)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

200 mg/m^2/Day RX-0201 + Everolimus (Stage 1)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

250 mg/m^2/Day RX-0201 + Everolimus (Stage 1)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

RX-0201 Plus Everolimus (Stage 2)

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	125 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=3 participants at risk RX-0201 was administered as 125 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	200 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=4 participants at risk RX-0201 was administered as 200 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) n=3 participants at risk RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days	RX-0201 Plus Everolimus (Stage 2) n=11 participants at risk RX-0201 was administered as 250 mg/m\^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of MTD in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	9.1% 1/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	33.3% 1/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
General disorders Oedema peripheral	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	9.1% 1/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
General disorders Pyrexia	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	9.1% 1/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
Infections and infestations Pseudomonas infection	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	9.1% 1/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	25.0% 1/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	33.3% 1/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	33.3% 1/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	33.3% 1/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
Renal and urinary disorders Renal failure acute	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	25.0% 1/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	25.0% 1/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	9.1% 1/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Angioedema	33.3% 1/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/4 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/3 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.	0.00% 0/11 • Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.

Other adverse events

Additional Information

Doug Swirsky/ Chief Executive Officer

Rexahn Pharmaceuticals Inc.

Phone: 240-268-5300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60