Trial Outcomes & Findings for Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects (NCT NCT01359982)
NCT ID: NCT01359982
Last Updated: 2024-11-01
Results Overview
The total number of patients who experienced at least one adverse event while receiving treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
From time of receiving a dose of RRx-001 through 92 days
Results posted on
2024-11-01
Participant Flow
Between Oct 10, 2011, and March 18, 2013, we screened 26 patients from the University of California- San Diego Moores Cancer Center, La Jolla, CA, USA, and the Sarah Cannon Research Institute, Nashville, TN, USA. 25 patients (1 ineligible) were treated.
One enrolled patient had a disease-associated serious adverse event and died before starting treatment and was not included in the analysis.
Participant milestones
| Measure |
RRx-001: Dose Level 1 (10 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 2 (16.7 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 3 (24.6 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 4 (33 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 5 (55.0 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 6 (83 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
4
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
RRx-001: Dose Level 1 (10 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 2 (16.7 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 3 (24.6 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 4 (33 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 5 (55.0 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 6 (83 mg/m2)
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects
Baseline characteristics by cohort
| Measure |
RRx-001: Dose Level 1 (10 mg/m2)
n=6 Participants
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 2 (16.7 mg/m2)
n=3 Participants
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 3 (24.6 mg/m2)
n=3 Participants
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 4 (33 mg/m2)
n=4 Participants
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 5 (55.0 mg/m2)
n=3 Participants
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
RRx-001: Dose Level 6 (83 mg/m2)
n=6 Participants
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.15 years
n=93 Participants
|
64.3 years
n=4 Participants
|
67.1 years
n=27 Participants
|
63.5 years
n=483 Participants
|
59.5 years
n=36 Participants
|
58.35 years
n=10 Participants
|
61.3 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
ECOG Status
ECOG 0
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
ECOG Status
ECOG 1
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
|
ECOG Status
ECOG 2
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From time of receiving a dose of RRx-001 through 92 daysPopulation: Total number of participants enrolled
The total number of patients who experienced at least one adverse event while receiving treatment.
Outcome measures
| Measure |
RRx-001: Dose Level 1 (10 mg/m2) to Dose Level 5 (83.0 mg/m2)
n=25 Participants
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
|---|---|
|
Number of Patients Who Had an Adverse Events
|
25 Participants
|
Adverse Events
RRx-001: Dose Level 1 (10 mg/m2) to Dose Level 5 (83.0 mg/m2)
Serious events: 11 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RRx-001: Dose Level 1 (10 mg/m2) to Dose Level 5 (83.0 mg/m2)
n=25 participants at risk
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Emphysematous cholecystitis
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Herpes simplex
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Seizure
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
1/25 • Number of events 1
|
Other adverse events
| Measure |
RRx-001: Dose Level 1 (10 mg/m2) to Dose Level 5 (83.0 mg/m2)
n=25 participants at risk
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
2/25 • Number of events 2
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.0%
2/25 • Number of events 2
|
|
Vascular disorders
Hypertension
|
8.0%
2/25 • Number of events 2
|
Additional Information
Study Director: Bryan Oronsky, Chief Medical Officer
EpicentRx, Inc
Phone: 8582291062
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place