Trial Outcomes & Findings for Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies (NCT NCT00481871)
NCT ID: NCT00481871
Last Updated: 2020-01-07
Results Overview
Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
119 participants
Primary outcome timeframe
Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I
Results posted on
2020-01-07
Participant Flow
Patients were enrolled between May 2007 and July 2010 across 16 study sites, all in the United States.
12 patients were enrolled but not treated. Of these, 9 patients had events after enrollment that rendered them ineligible; 2 patients had progressive disease (PD); 1 patient withdrew consent. Since they were never dosed, these 12 patients were not included in efficacy or safety assessments.
Participant milestones
| Measure |
Phase 1 Group A - Dose Finding
Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
|
Phase 1 Group B - Dose Finding
Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
|
Phase 1 Group C - Dose Finding
Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
|
Phase 2 Group B
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
|
Phase 2 Group C
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
18
|
38
|
34
|
|
Overall Study
COMPLETED
|
7
|
10
|
17
|
38
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1 Group A - Dose Finding
Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
|
Phase 1 Group B - Dose Finding
Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
|
Phase 1 Group C - Dose Finding
Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
|
Phase 2 Group B
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
|
Phase 2 Group C
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive Disease - pt withdrew
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies
Baseline characteristics by cohort
| Measure |
Phase 1 - Group A
n=7 Participants
Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
|
Phase 1 - Group B
n=10 Participants
Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
|
Phase 1 - Group C
n=18 Participants
Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
|
Phase 2 - Group B
n=38 Participants
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
|
Phase 2 - Group C
n=34 Participants
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
71 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 15 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 18 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 17 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 16 • n=4 Participants
|
53.2 years
STANDARD_DEVIATION 15 • n=21 Participants
|
56.4 years
STANDARD_DEVIATION 16.1 • n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
65 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
38 participants
n=4 Participants
|
34 participants
n=21 Participants
|
107 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase IPopulation: All patients who completed at least 1 cycle of treatment were included in the efficacy analysis
Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.
Outcome measures
| Measure |
Phase 1
n=34 Participants
Includes the Phase 1 dose-finding groups A, B, and C
|
Phase 2 - Group B
n=38 Participants
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
|
Phase 2 - Group C
n=34 Participants
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
|
|---|---|---|---|
|
Objective Responses Assessed by International Workshop Criteria (IWC)
|
8 participants
|
5 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the studyDuration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death - date of first objective response assessment + 1)
Outcome measures
| Measure |
Phase 1
n=8 Participants
Includes the Phase 1 dose-finding groups A, B, and C
|
Phase 2 - Group B
n=5 Participants
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
|
Phase 2 - Group C
n=7 Participants
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
|
|---|---|---|---|
|
Duration of Response
|
174 days
Interval 35.0 to 288.0
|
210 days
Interval 57.0 to 210.0
|
170 days
Interval 59.0 to 178.0
|
SECONDARY outcome
Timeframe: Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the studyPFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death - study day 1 + 1).
Outcome measures
| Measure |
Phase 1
n=34 Participants
Includes the Phase 1 dose-finding groups A, B, and C
|
Phase 2 - Group B
n=38 Participants
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
|
Phase 2 - Group C
n=34 Participants
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
|
|---|---|---|---|
|
Progression-free Survival (PFS) Time
|
53.0 days
Interval 49.0 to 106.0
|
59.0 days
Interval 52.0 to 99.0
|
54.0 days
Interval 45.0 to 89.0
|
Adverse Events
Phase 1
Serious events: 18 serious events
Other events: 35 other events
Deaths: 0 deaths
Phase 2 - Group B
Serious events: 13 serious events
Other events: 38 other events
Deaths: 0 deaths
Phase 2 - Group C
Serious events: 16 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1
n=35 participants at risk
Patients that received at least one dose of pralatrexate in the Phase 1 portion of the study
|
Phase 2 - Group B
n=38 participants at risk
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
|
Phase 2 - Group C
n=34 participants at risk
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
|
|---|---|---|---|
|
Nervous system disorders
altered state of consciousness
|
2.9%
1/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Cardiac disorders
arrhythmia
|
2.9%
1/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Cardiac disorders
cardiac failure congestive
|
2.9%
1/35
|
2.6%
1/38
|
2.9%
1/34
|
|
Infections and infestations
cellulitis
|
8.6%
3/35
|
2.6%
1/38
|
2.9%
1/34
|
|
Psychiatric disorders
delirium tremens
|
2.9%
1/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
5.7%
2/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Psychiatric disorders
mental status changes
|
2.9%
1/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Cardiac disorders
myocardial infarction
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
pancytopenia
|
2.9%
1/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
2.9%
1/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Infections and infestations
pneumonia
|
8.6%
3/35
|
2.6%
1/38
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
5.7%
2/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
2.9%
1/35
|
0.00%
0/38
|
0.00%
0/34
|
|
General disorders
pyrexia
|
5.7%
2/35
|
10.5%
4/38
|
20.6%
7/34
|
|
Cardiac disorders
tachycardia
|
2.9%
1/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
2.9%
1/35
|
2.6%
1/38
|
2.9%
1/34
|
|
Vascular disorders
thrombophlebitis superficial
|
2.9%
1/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
upper airway obstruction
|
2.9%
1/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Investigations
weight decreased
|
2.9%
1/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Infections and infestations
sepsis
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
anaemia
|
0.00%
0/35
|
5.3%
2/38
|
0.00%
0/34
|
|
General disorders
chills
|
0.00%
0/35
|
2.6%
1/38
|
2.9%
1/34
|
|
Renal and urinary disorders
renal failure acute
|
0.00%
0/35
|
5.3%
2/38
|
5.9%
2/34
|
|
General disorders
fatigue
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
General disorders
multi-organ failure
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Infections and infestations
bacteraemia
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Infections and infestations
oral candidiasis
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Infections and infestations
respiratory syncytial virus infection
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Infections and infestations
sepsis syndrome
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/35
|
0.00%
0/38
|
11.8%
4/34
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
pleurisy
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Blood and lymphatic system disorders
neutropenia
|
0.00%
0/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Cardiac disorders
atrial flutter
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Cardiac disorders
bradycardia
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Cardiac disorders
cardio-respiratory arrest
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Gastrointestinal disorders
oesophagitis
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Gastrointestinal disorders
stomatitis
|
0.00%
0/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Renal and urinary disorders
hydronephrosis
|
0.00%
0/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Vascular disorders
hypotension
|
0.00%
0/35
|
5.3%
2/38
|
2.9%
1/34
|
|
Vascular disorders
lymphoedema
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
femoral neck fracture
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Nervous system disorders
cerebral haemorrhage
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
General disorders
asthenia
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
General disorders
pain
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Metabolism and nutrition disorders
electrolyte imbalance
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
hyponatraemia
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
hypovolaemia
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Cardiac disorders
ventricular arrhythmia
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Injury, poisoning and procedural complications
accidental overdose
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumor lysis syndrome
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
skin exfoliation
|
0.00%
0/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Surgical and medical procedures
pain management
|
0.00%
0/35
|
0.00%
0/38
|
2.9%
1/34
|
Other adverse events
| Measure |
Phase 1
n=35 participants at risk
Patients that received at least one dose of pralatrexate in the Phase 1 portion of the study
|
Phase 2 - Group B
n=38 participants at risk
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
|
Phase 2 - Group C
n=34 participants at risk
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
|
|---|---|---|---|
|
General disorders
fatigue
|
71.4%
25/35
|
47.4%
18/38
|
44.1%
15/34
|
|
General disorders
pyrexia
|
65.7%
23/35
|
47.4%
18/38
|
44.1%
15/34
|
|
General disorders
chills
|
17.1%
6/35
|
31.6%
12/38
|
11.8%
4/34
|
|
General disorders
oedema peripheral
|
14.3%
5/35
|
15.8%
6/38
|
17.6%
6/34
|
|
General disorders
influenza like illness
|
8.6%
3/35
|
2.6%
1/38
|
0.00%
0/34
|
|
General disorders
asthenia
|
5.7%
2/35
|
10.5%
4/38
|
8.8%
3/34
|
|
General disorders
chest discomfort
|
5.7%
2/35
|
2.6%
1/38
|
2.9%
1/34
|
|
General disorders
chest pain
|
5.7%
2/35
|
2.6%
1/38
|
2.9%
1/34
|
|
General disorders
non-cardiac chest pain
|
5.7%
2/35
|
0.00%
0/38
|
8.8%
3/34
|
|
Gastrointestinal disorders
stomatitis
|
45.7%
16/35
|
23.7%
9/38
|
35.3%
12/34
|
|
Gastrointestinal disorders
nausea
|
42.9%
15/35
|
63.2%
24/38
|
61.8%
21/34
|
|
Gastrointestinal disorders
diarrhoea
|
37.1%
13/35
|
28.9%
11/38
|
23.5%
8/34
|
|
Gastrointestinal disorders
vomiting
|
34.3%
12/35
|
26.3%
10/38
|
26.5%
9/34
|
|
Gastrointestinal disorders
constipation
|
28.6%
10/35
|
26.3%
10/38
|
35.3%
12/34
|
|
Gastrointestinal disorders
abdominal pain upper
|
8.6%
3/35
|
2.6%
1/38
|
11.8%
4/34
|
|
Gastrointestinal disorders
abdominal pain
|
5.7%
2/35
|
15.8%
6/38
|
17.6%
6/34
|
|
Gastrointestinal disorders
dysphagia
|
5.7%
2/35
|
5.3%
2/38
|
2.9%
1/34
|
|
Gastrointestinal disorders
epigastric discomfort
|
5.7%
2/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
5.7%
2/35
|
2.6%
1/38
|
2.9%
1/34
|
|
Gastrointestinal disorders
gingival pain
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Gastrointestinal disorders
glossodynia
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Gastrointestinal disorders
haematochezia
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Gastrointestinal disorders
oral pain
|
5.7%
2/35
|
7.9%
3/38
|
5.9%
2/34
|
|
Blood and lymphatic system disorders
anaemia
|
54.3%
19/35
|
36.8%
14/38
|
26.5%
9/34
|
|
Blood and lymphatic system disorders
neutropenia
|
45.7%
16/35
|
36.8%
14/38
|
23.5%
8/34
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
40.0%
14/35
|
42.1%
16/38
|
23.5%
8/34
|
|
Blood and lymphatic system disorders
leukopenia
|
14.3%
5/35
|
10.5%
4/38
|
8.8%
3/34
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
8.6%
3/35
|
5.3%
2/38
|
2.9%
1/34
|
|
Blood and lymphatic system disorders
lymphopenia
|
5.7%
2/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
pancytopenia
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
20.0%
7/35
|
13.2%
5/38
|
26.5%
9/34
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
20.0%
7/35
|
5.3%
2/38
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
17.1%
6/35
|
21.1%
8/38
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
14.3%
5/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
11.4%
4/35
|
5.3%
2/38
|
11.8%
4/34
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
11.4%
4/35
|
15.8%
6/38
|
11.8%
4/34
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
11.4%
4/35
|
5.3%
2/38
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
dysphonia
|
8.6%
3/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
8.6%
3/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
pleuritic pain
|
5.7%
2/35
|
2.6%
1/38
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
5.7%
2/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis allergic
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Infections and infestations
cellulitis
|
11.4%
4/35
|
2.6%
1/38
|
0.00%
0/34
|
|
Infections and infestations
pneumonia
|
11.4%
4/35
|
5.3%
2/38
|
8.8%
3/34
|
|
Infections and infestations
oral candidiasis
|
5.7%
2/35
|
5.3%
2/38
|
5.9%
2/34
|
|
Infections and infestations
upper respiratory tract infection
|
5.7%
2/35
|
7.9%
3/38
|
8.8%
3/34
|
|
Nervous system disorders
dizziness
|
22.9%
8/35
|
13.2%
5/38
|
23.5%
8/34
|
|
Nervous system disorders
paraesthesia
|
22.9%
8/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Nervous system disorders
headache
|
20.0%
7/35
|
23.7%
9/38
|
17.6%
6/34
|
|
Nervous system disorders
neuropathy peripheral
|
11.4%
4/35
|
7.9%
3/38
|
5.9%
2/34
|
|
Nervous system disorders
hypoaesthesia
|
5.7%
2/35
|
5.3%
2/38
|
5.9%
2/34
|
|
Investigations
alanine aminotransferase increased
|
11.4%
4/35
|
7.9%
3/38
|
11.8%
4/34
|
|
Investigations
alanine aminotransferase
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Investigations
aspartate aminotransferase increased
|
5.7%
2/35
|
7.9%
3/38
|
5.9%
2/34
|
|
Investigations
blood creatinine increased
|
5.7%
2/35
|
5.3%
2/38
|
5.9%
2/34
|
|
Investigations
cardiac murmur
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Investigations
platelet count decreased
|
5.7%
2/35
|
2.6%
1/38
|
5.9%
2/34
|
|
Investigations
weight decreased
|
5.7%
2/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Investigations
white blood cell count
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
rash
|
14.3%
5/35
|
5.3%
2/38
|
5.9%
2/34
|
|
Skin and subcutaneous tissue disorders
alopecia
|
11.4%
4/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
pruritus
|
11.4%
4/35
|
13.2%
5/38
|
14.7%
5/34
|
|
Skin and subcutaneous tissue disorders
erythema
|
8.6%
3/35
|
5.3%
2/38
|
5.9%
2/34
|
|
Skin and subcutaneous tissue disorders
night sweats
|
8.6%
3/35
|
13.2%
5/38
|
5.9%
2/34
|
|
Skin and subcutaneous tissue disorders
swelling face
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
back pain
|
14.3%
5/35
|
10.5%
4/38
|
8.8%
3/34
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
11.4%
4/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
8.6%
3/35
|
10.5%
4/38
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
5.7%
2/35
|
2.6%
1/38
|
11.8%
4/34
|
|
Vascular disorders
hypotension
|
17.1%
6/35
|
7.9%
3/38
|
8.8%
3/34
|
|
Vascular disorders
flushing
|
5.7%
2/35
|
2.6%
1/38
|
5.9%
2/34
|
|
Vascular disorders
hypertension
|
5.7%
2/35
|
2.6%
1/38
|
2.9%
1/34
|
|
Metabolism and nutrition disorders
decreased appetite
|
14.3%
5/35
|
7.9%
3/38
|
2.9%
1/34
|
|
Metabolism and nutrition disorders
anorexia
|
8.6%
3/35
|
18.4%
7/38
|
14.7%
5/34
|
|
Metabolism and nutrition disorders
hyperuricaemia
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Cardiac disorders
palpitations
|
11.4%
4/35
|
0.00%
0/38
|
2.9%
1/34
|
|
Cardiac disorders
tachycardia
|
8.6%
3/35
|
7.9%
3/38
|
5.9%
2/34
|
|
Cardiac disorders
myocardial infarction
|
5.7%
2/35
|
0.00%
0/38
|
0.00%
0/34
|
|
Psychiatric disorders
anxiety
|
8.6%
3/35
|
7.9%
3/38
|
2.9%
1/34
|
|
Gastrointestinal disorders
abdominal discomfort
|
2.9%
1/35
|
0.00%
0/38
|
8.8%
3/34
|
|
Gastrointestinal disorders
lip pain
|
0.00%
0/35
|
5.3%
2/38
|
0.00%
0/34
|
|
General disorders
pain
|
2.9%
1/35
|
5.3%
2/38
|
11.8%
4/34
|
|
Nervous system disorders
memory impairment
|
0.00%
0/35
|
2.6%
1/38
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
2.9%
1/35
|
7.9%
3/38
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
2.9%
1/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
2.9%
1/35
|
7.9%
3/38
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
2.9%
1/35
|
10.5%
4/38
|
17.6%
6/34
|
|
Skin and subcutaneous tissue disorders
rash pruritic
|
0.00%
0/35
|
18.4%
7/38
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
rash erythematous
|
0.00%
0/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
0.00%
0/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
skin lesion
|
2.9%
1/35
|
2.6%
1/38
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea exertional
|
2.9%
1/35
|
7.9%
3/38
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/35
|
2.6%
1/38
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
haemoptysis
|
2.9%
1/35
|
7.9%
3/38
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
rales
|
0.00%
0/35
|
5.3%
2/38
|
2.9%
1/34
|
|
Investigations
neutrophil count decreased
|
2.9%
1/35
|
15.8%
6/38
|
5.9%
2/34
|
|
Investigations
weight increased
|
0.00%
0/35
|
5.3%
2/38
|
2.9%
1/34
|
|
Infections and infestations
sepsis syndrome
|
0.00%
0/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
dehydration
|
2.9%
1/35
|
2.6%
1/38
|
8.8%
3/34
|
|
Metabolism and nutrition disorders
hypocalcaemia
|
0.00%
0/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
hypokalaemia
|
2.9%
1/35
|
2.6%
1/38
|
14.7%
5/34
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
0.00%
0/35
|
5.3%
2/38
|
8.8%
3/34
|
|
Eye disorders
lacrimation increased
|
0.00%
0/35
|
2.6%
1/38
|
5.9%
2/34
|
|
Renal and urinary disorders
renal failure acute
|
0.00%
0/35
|
5.3%
2/38
|
8.8%
3/34
|
|
Ear and labyrinth disorders
ear pain
|
0.00%
0/35
|
7.9%
3/38
|
2.9%
1/34
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
8.6%
3/35
|
2.6%
1/38
|
8.8%
3/34
|
|
General disorders
catheter site pain
|
0.00%
0/35
|
5.3%
2/38
|
0.00%
0/34
|
|
General disorders
pitting oedema
|
0.00%
0/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
groin pain
|
0.00%
0/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
2.9%
1/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/35
|
5.3%
2/38
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
urticaria
|
2.9%
1/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Investigations
white blood cell count decreased
|
2.9%
1/35
|
7.9%
3/38
|
2.9%
1/34
|
|
Investigations
blood lactate dehydrogenase increased
|
0.00%
0/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Cardiac disorders
sinus tachycardia
|
0.00%
0/35
|
2.6%
1/38
|
5.9%
2/34
|
|
Cardiac disorders
bradycardia
|
2.9%
1/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Renal and urinary disorders
hydronephrosis
|
2.9%
1/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Renal and urinary disorders
incontinence
|
0.00%
0/35
|
5.3%
2/38
|
0.00%
0/34
|
|
Psychiatric disorders
insomnia
|
2.9%
1/35
|
2.6%
1/38
|
8.8%
3/34
|
|
Psychiatric disorders
confusional state
|
0.00%
0/35
|
2.6%
1/38
|
5.9%
2/34
|
|
Eye disorders
vision blurred
|
2.9%
1/35
|
2.6%
1/38
|
8.8%
3/34
|
|
Eye disorders
ocular hyperaemia
|
2.9%
1/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Infections and infestations
urinary tract infection
|
8.6%
3/35
|
2.6%
1/38
|
5.9%
2/34
|
|
Investigations
haemoglobin decreased
|
2.9%
1/35
|
13.2%
5/38
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
0.00%
0/35
|
2.6%
1/38
|
5.9%
2/34
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
0.00%
0/35
|
0.00%
0/38
|
5.9%
2/34
|
|
Metabolism and nutrition disorders
hyponatraemia
|
2.9%
1/35
|
10.5%
4/38
|
0.00%
0/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Allos agreements with investigators (PIs) may vary. The PI may publish/make public data from the trial after the earlier of publication by Allos or 18 months after study completion. Allos can review results communications prior to public release and can embargo communications regarding trial results for a period less than or equal to 90 days from submission for review. Allos can request changes to the communication related to confidential or patent information, or to ensure accuracy.
- Publication restrictions are in place
Restriction type: OTHER