Trial Outcomes & Findings for A Trial of PledOx + FOLFOX6 Compared to Placebo + FOLFOX6 in Patients With Metastatic Colorectal Cancer (NCT NCT01619423)
NCT ID: NCT01619423
Last Updated: 2018-07-06
Results Overview
Percentage of patients, over cycle 1 to 8, with neuropathy grade 2 or higher (according to the Oxaliplatin Specific Sanofi Scale (OSSS) criteria related paraesthesiae/dysaesthesiae)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
186 participants
Primary outcome timeframe
Every second week during cycle 1-8, for up to 16 weeks
Results posted on
2018-07-06
Participant Flow
186 participants were enrolled and 186 started the study, however, two patients had too high basal manganese levels (detected after first treatment cycle) and were excluded from further treatment (screening failures) but are part of the safety population. 184 patients are part of the treatment population (11 in part 1 and 173 in part 2)
Participant milestones
| Measure |
FOLFOX6 + 0,9% NaCl (Part 2a+2b)
Placebo= 0.9% NaCl; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
Placebo (0,9% NaCl): Placebo (0,9% NaCl) is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 2 µmol/kg (Part 1, 2a+2b)
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (2 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 5 µmol/kg (Part 1, 2b)
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (5 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 10 µmol/kg (Part 1, 2a)
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (10 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
|---|---|---|---|---|
|
Part 1 (Dose Escalation)
STARTED
|
0
|
5
|
3
|
5
|
|
Part 1 (Dose Escalation)
COMPLETED
|
0
|
3
|
3
|
5
|
|
Part 1 (Dose Escalation)
NOT COMPLETED
|
0
|
2
|
0
|
0
|
|
Part 2a
STARTED
|
15
|
13
|
0
|
11
|
|
Part 2a
COMPLETED
|
15
|
13
|
0
|
11
|
|
Part 2a
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2b
STARTED
|
45
|
44
|
45
|
0
|
|
Part 2b
COMPLETED
|
45
|
44
|
45
|
0
|
|
Part 2b
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
FOLFOX6 + 0,9% NaCl (Part 2a+2b)
Placebo= 0.9% NaCl; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
Placebo (0,9% NaCl): Placebo (0,9% NaCl) is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 2 µmol/kg (Part 1, 2a+2b)
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (2 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 5 µmol/kg (Part 1, 2b)
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (5 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 10 µmol/kg (Part 1, 2a)
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (10 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
|---|---|---|---|---|
|
Part 1 (Dose Escalation)
High basal Mn
|
0
|
2
|
0
|
0
|
Baseline Characteristics
A Trial of PledOx + FOLFOX6 Compared to Placebo + FOLFOX6 in Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
FOLFOX6 + 0,9% NaCl (Part 2a+2b)
n=60 Participants
Placebo= 0.9% NaCl; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
Placebo (0,9% NaCl): Placebo (0,9% NaCl) is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 2 µmol/kg (Part 1, 2a+2b)
n=62 Participants
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (2 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 5 µmol/kg (Part 1, 2b)
n=48 Participants
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (5 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 10 µmol/kg (Part 1, 2a)
n=16 Participants
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (10 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
63.5 years
n=7 Participants
|
62.6 years
n=5 Participants
|
61.3 years
n=4 Participants
|
62.6 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
61 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=5 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
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 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=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
180 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Every second week during cycle 1-8, for up to 16 weeksPopulation: Full analysis set
Percentage of patients, over cycle 1 to 8, with neuropathy grade 2 or higher (according to the Oxaliplatin Specific Sanofi Scale (OSSS) criteria related paraesthesiae/dysaesthesiae)
Outcome measures
| Measure |
Placebo
n=60 Participants
Control group
|
FOLFOX6 + PledOx 2 µmol/kg
n=57 Participants
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (2 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 5+10 µmol/kg
n=56 Participants
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
Combined PledOx (5 and 10 µmol/kg groups): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 2+5+10 µmol/kg
n=113 Participants
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
Combined PledOx (2, 5 and 10 µmol/kg groups): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
|---|---|---|---|---|
|
Number of Patients With Neuropathy Grade 2 or Higher (According to the Oxaliplatin Specific Sanofi Scale (OSSS) Criteria Related Paraesthesia/Dysaesthesia)
|
14 Participants
|
11 Participants
|
6 Participants
|
17 Participants
|
Adverse Events
FOLFOX6 + 0,9% NaCl (Part 2a+2b)
Serious events: 6 serious events
Other events: 49 other events
Deaths: 2 deaths
Part 1 (Dose Escalation)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
FOLFOX6 + PledOx 2 µmol/kg (Part 2a+2b)
Serious events: 7 serious events
Other events: 45 other events
Deaths: 1 deaths
FOLFOX6 + PledOx 5 µmol/kg (Part 2b)
Serious events: 3 serious events
Other events: 35 other events
Deaths: 1 deaths
FOLFOX6 + PledOx 10 µmol/kg (Part 2a)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
FOLFOX6 + 0,9% NaCl (Part 2a+2b)
n=60 participants at risk
Placebo= 0.9% NaCl; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
Placebo (0,9% NaCl): Placebo (0,9% NaCl) is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
Part 1 (Dose Escalation)
n=13 participants at risk
Part 1 is an open dose-escalation part with the doses 2, 5 and 10 µmol/kg of PledOx with the active ingridient calmangafodipir
|
FOLFOX6 + PledOx 2 µmol/kg (Part 2a+2b)
n=57 participants at risk
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (2 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 5 µmol/kg (Part 2b)
n=45 participants at risk
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (5 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 10 µmol/kg (Part 2a)
n=11 participants at risk
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (10 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
|---|---|---|---|---|---|
|
Infections and infestations
Device related infection
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
1.8%
1/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Infections and infestations
Infection
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
2.2%
1/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
9.1%
1/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Infections and infestations
Staphyloccocal infection
|
1.7%
1/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Immune system disorders
Hypersensitivty
|
1.7%
1/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
9.1%
1/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
1.8%
1/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
2.2%
1/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Gastrointestinal disorders
Ileus
|
1.7%
1/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
9.1%
1/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
1.8%
1/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Gastrointestinal disorders
Small intestine obstruction
|
1.7%
1/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
1.8%
1/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
General disorders
Death
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
2.2%
1/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
General disorders
Cheast pain
|
1.7%
1/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
General disorders
Pyrexia
|
1.7%
1/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
1.8%
1/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
2.2%
1/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
1.8%
1/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Injury, poisoning and procedural complications
Stoma site hemorrhage
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
1.8%
1/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Injury, poisoning and procedural complications
Brain contusion
|
1.7%
1/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Surgical and medical procedures
Central venous catherization
|
1.7%
1/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Surgical and medical procedures
Stoma closure
|
1.7%
1/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
1.8%
1/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
7.7%
1/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
7.7%
1/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
7.7%
1/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
7.7%
1/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
Other adverse events
| Measure |
FOLFOX6 + 0,9% NaCl (Part 2a+2b)
n=60 participants at risk
Placebo= 0.9% NaCl; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
Placebo (0,9% NaCl): Placebo (0,9% NaCl) is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
Part 1 (Dose Escalation)
n=13 participants at risk
Part 1 is an open dose-escalation part with the doses 2, 5 and 10 µmol/kg of PledOx with the active ingridient calmangafodipir
|
FOLFOX6 + PledOx 2 µmol/kg (Part 2a+2b)
n=57 participants at risk
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (2 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 5 µmol/kg (Part 2b)
n=45 participants at risk
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (5 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
FOLFOX6 + PledOx 10 µmol/kg (Part 2a)
n=11 participants at risk
PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.
PledOx (10 µmol/kg): PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorder
|
81.7%
49/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
76.9%
10/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
78.9%
45/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
77.8%
35/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
81.8%
9/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Nervous system disorders
Nervous system disorder
|
78.3%
47/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
53.8%
7/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
77.2%
44/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
71.1%
32/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
72.7%
8/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
60.0%
36/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
69.2%
9/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
54.4%
31/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
71.1%
32/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
72.7%
8/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
General disorders
General disorders
|
58.3%
35/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
15.4%
2/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
42.1%
24/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
62.2%
28/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
18.2%
2/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
31.7%
19/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
38.5%
5/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
31.6%
18/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
24.4%
11/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
18.2%
2/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal
|
11.7%
7/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
15.4%
2/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
12.3%
7/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
15.6%
7/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue
|
11.7%
7/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
15.4%
2/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
12.3%
7/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
6.7%
3/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
18.2%
2/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Infections and infestations
Infections and infestations
|
6.7%
4/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
15.4%
2/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
10.5%
6/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
6.7%
3/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Investigations
Investigations
|
10.0%
6/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
7.7%
1/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
8.8%
5/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
11.1%
5/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
18.2%
2/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Musculoskeletal and connective tissue disorders
Musculosceletal and connective tissue
|
11.7%
7/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
15.4%
2/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
5.3%
3/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
13.3%
6/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
9.1%
1/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
7.7%
1/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
|
Immune system disorders
Type IV hypersensitivity reaction
|
0.00%
0/60 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
7.7%
1/13 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/57 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/45 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
0.00%
0/11 • 30 days after last treatment for newly occuring AE:s and until resolution for ongoing, up to 2 years from baseline
|
Additional Information
Stefan Carlsson, MD, PhD, Chief Medical Officer
PledPharma AB
Phone: +46 8 679 72 10
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place