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Trial record 15 of 19 for:    pralatrexate AND PTCL

Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00481871
Recruitment Status : Completed
First Posted : June 4, 2007
Results First Posted : September 18, 2012
Last Update Posted : May 10, 2013
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Relapsed or Refractory Lymphoproliferative Malignancies
Hodgkin's Lymphoma
Peripheral T-cell Lymphoma
B-cell Lymphoma
Waldenstrom's Macroglobulinemia
Interventions Drug: Pralatrexate Injection
Drug: Gemcitabine Hydrochloride
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid
Enrollment 119
Recruitment Details Patients were enrolled between May 2007 and July 2010 across 16 study sites, all in the United States.
Pre-assignment Details 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.
Arm/Group Title Phase 1 Group A - Dose Finding Phase 1 Group B - Dose Finding Phase 1 Group C - Dose Finding Phase 2 Group B Phase 2 Group C
Hide Arm/Group Description 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 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 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 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 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.
Period Title: Overall Study
Started 7 10 18 38 34
Completed 7 10 17 38 34
Not Completed 0 0 1 0 0
Reason Not Completed
Progressive Disease - pt withdrew             0             0             1             0             0
Arm/Group Title Phase 1 - Group A Phase 1 - Group B Phase 1 - Group C Phase 2 - Group B Phase 2 - Group C Total
Hide Arm/Group Description 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 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 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 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 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 of all reporting groups
Overall Number of Baseline Participants 7 10 18 38 34 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 18 participants 38 participants 34 participants 107 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  28.6%
7
  70.0%
10
  55.6%
24
  63.2%
28
  82.4%
71
  66.4%
>=65 years
5
  71.4%
3
  30.0%
8
  44.4%
14
  36.8%
6
  17.6%
36
  33.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 10 participants 18 participants 38 participants 34 participants 107 participants
67.6  (15) 52.4  (18) 57.4  (17) 57.9  (16) 53.2  (15) 56.4  (16.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 18 participants 38 participants 34 participants 107 participants
Female
4
  57.1%
3
  30.0%
4
  22.2%
17
  44.7%
14
  41.2%
42
  39.3%
Male
3
  42.9%
7
  70.0%
14
  77.8%
21
  55.3%
20
  58.8%
65
  60.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 10 participants 18 participants 38 participants 34 participants 107 participants
7 10 18 38 34 107
1.Primary Outcome
Title Objective Responses Assessed by International Workshop Criteria (IWC)
Hide Description 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.
Time Frame Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed at least 1 cycle of treatment were included in the efficacy analysis
Arm/Group Title Phase 1 Phase 2 - Group B Phase 2 - Group C
Hide Arm/Group Description:
Includes the Phase 1 dose-finding groups A, B, and C
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 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 Number of Participants Analyzed 34 38 34
Measure Type: Number
Unit of Measure: participants
8 5 7
2.Secondary Outcome
Title Duration of Response
Hide Description Duration 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)
Time Frame 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 study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1 Phase 2 - Group B Phase 2 - Group C
Hide Arm/Group Description:
Includes the Phase 1 dose-finding groups A, B, and C
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 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 Number of Participants Analyzed 8 5 7
Median (Full Range)
Unit of Measure: days
174
(35 to 288)
210
(57 to 210)
170
(59 to 178)
3.Secondary Outcome
Title Progression-free Survival (PFS) Time
Hide Description PFS 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).
Time Frame 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 study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1 Phase 2 - Group B Phase 2 - Group C
Hide Arm/Group Description:
Includes the Phase 1 dose-finding groups A, B, and C
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 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 Number of Participants Analyzed 34 38 34
Median (95% Confidence Interval)
Unit of Measure: days
53.0
(49.0 to 106.0)
59.0
(52.0 to 99.0)
54.0
(45.0 to 89.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1 Phase 2 - Group B Phase 2 - Group C
Hide Arm/Group Description Patients that received at least one dose of pralatrexate in the Phase 1 portion of the study 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 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.
All-Cause Mortality
Phase 1 Phase 2 - Group B Phase 2 - Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase 1 Phase 2 - Group B Phase 2 - Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/35 (51.43%)   13/38 (34.21%)   16/34 (47.06%) 
Blood and lymphatic system disorders       
febrile neutropenia  2/35 (5.71%)  1/38 (2.63%)  0/34 (0.00%) 
pancytopenia  1/35 (2.86%)  0/38 (0.00%)  0/34 (0.00%) 
thrombocytopenia  1/35 (2.86%)  1/38 (2.63%)  1/34 (2.94%) 
anaemia  0/35 (0.00%)  2/38 (5.26%)  0/34 (0.00%) 
neutropenia  0/35 (0.00%)  0/38 (0.00%)  2/34 (5.88%) 
Cardiac disorders       
arrhythmia  1/35 (2.86%)  0/38 (0.00%)  0/34 (0.00%) 
cardiac failure congestive  1/35 (2.86%)  1/38 (2.63%)  1/34 (2.94%) 
myocardial infarction  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
tachycardia  1/35 (2.86%)  1/38 (2.63%)  0/34 (0.00%) 
atrial flutter  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
bradycardia  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
cardio-respiratory arrest  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
ventricular arrhythmia  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
Gastrointestinal disorders       
diarrhoea  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
oesophagitis  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
stomatitis  0/35 (0.00%)  0/38 (0.00%)  2/34 (5.88%) 
abdominal pain  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
small intestinal obstruction  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
General disorders       
pyrexia  2/35 (5.71%)  4/38 (10.53%)  7/34 (20.59%) 
chills  0/35 (0.00%)  1/38 (2.63%)  1/34 (2.94%) 
fatigue  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
multi-organ failure  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
asthenia  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
non-cardiac chest pain  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
pain  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
Infections and infestations       
cellulitis  3/35 (8.57%)  1/38 (2.63%)  1/34 (2.94%) 
pneumonia  3/35 (8.57%)  1/38 (2.63%)  2/34 (5.88%) 
sepsis  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
bacteraemia  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
oral candidiasis  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
respiratory syncytial virus infection  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
sepsis syndrome  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
urinary tract infection  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
Injury, poisoning and procedural complications       
femoral neck fracture  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
accidental overdose  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
Investigations       
weight decreased  1/35 (2.86%)  0/38 (0.00%)  0/34 (0.00%) 
Metabolism and nutrition disorders       
dehydration  0/35 (0.00%)  0/38 (0.00%)  2/34 (5.88%) 
electrolyte imbalance  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
hyponatraemia  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
hypovolaemia  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
Musculoskeletal and connective tissue disorders       
back pain  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
muscular weakness  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
musculoskeletal chest pain  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
tumor lysis syndrome  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
Nervous system disorders       
altered state of consciousness  1/35 (2.86%)  0/38 (0.00%)  0/34 (0.00%) 
cerebral haemorrhage  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
Psychiatric disorders       
delirium tremens  1/35 (2.86%)  0/38 (0.00%)  0/34 (0.00%) 
mental status changes  1/35 (2.86%)  0/38 (0.00%)  0/34 (0.00%) 
Renal and urinary disorders       
renal failure acute  0/35 (0.00%)  2/38 (5.26%)  2/34 (5.88%) 
hydronephrosis  0/35 (0.00%)  0/38 (0.00%)  2/34 (5.88%) 
Respiratory, thoracic and mediastinal disorders       
pleural effusion  1/35 (2.86%)  0/38 (0.00%)  0/34 (0.00%) 
pneumonitis  2/35 (5.71%)  1/38 (2.63%)  0/34 (0.00%) 
pulmonary embolism  1/35 (2.86%)  0/38 (0.00%)  0/34 (0.00%) 
upper airway obstruction  1/35 (2.86%)  0/38 (0.00%)  0/34 (0.00%) 
dyspnoea  0/35 (0.00%)  0/38 (0.00%)  4/34 (11.76%) 
hypoxia  0/35 (0.00%)  0/38 (0.00%)  2/34 (5.88%) 
pharyngolaryngeal pain  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
pleurisy  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
Skin and subcutaneous tissue disorders       
rash maculo-papular  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
skin exfoliation  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
Surgical and medical procedures       
pain management  0/35 (0.00%)  0/38 (0.00%)  1/34 (2.94%) 
Vascular disorders       
thrombophlebitis superficial  1/35 (2.86%)  0/38 (0.00%)  0/34 (0.00%) 
hypotension  0/35 (0.00%)  2/38 (5.26%)  1/34 (2.94%) 
lymphoedema  0/35 (0.00%)  1/38 (2.63%)  0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1 Phase 2 - Group B Phase 2 - Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/35 (100.00%)   38/38 (100.00%)   34/34 (100.00%) 
Blood and lymphatic system disorders       
anaemia  19/35 (54.29%)  14/38 (36.84%)  9/34 (26.47%) 
neutropenia  16/35 (45.71%)  14/38 (36.84%)  8/34 (23.53%) 
thrombocytopenia  14/35 (40.00%)  16/38 (42.11%)  8/34 (23.53%) 
leukopenia  5/35 (14.29%)  4/38 (10.53%)  3/34 (8.82%) 
febrile neutropenia  3/35 (8.57%)  2/38 (5.26%)  1/34 (2.94%) 
lymphopenia  2/35 (5.71%)  1/38 (2.63%)  0/34 (0.00%) 
pancytopenia  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
Cardiac disorders       
palpitations  4/35 (11.43%)  0/38 (0.00%)  1/34 (2.94%) 
tachycardia  3/35 (8.57%)  3/38 (7.89%)  2/34 (5.88%) 
myocardial infarction  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
sinus tachycardia  0/35 (0.00%)  1/38 (2.63%)  2/34 (5.88%) 
bradycardia  1/35 (2.86%)  0/38 (0.00%)  2/34 (5.88%) 
Ear and labyrinth disorders       
ear pain  0/35 (0.00%)  3/38 (7.89%)  1/34 (2.94%) 
Eye disorders       
lacrimation increased  0/35 (0.00%)  1/38 (2.63%)  2/34 (5.88%) 
vision blurred  1/35 (2.86%)  1/38 (2.63%)  3/34 (8.82%) 
ocular hyperaemia  1/35 (2.86%)  0/38 (0.00%)  2/34 (5.88%) 
Gastrointestinal disorders       
stomatitis  16/35 (45.71%)  9/38 (23.68%)  12/34 (35.29%) 
nausea  15/35 (42.86%)  24/38 (63.16%)  21/34 (61.76%) 
diarrhoea  13/35 (37.14%)  11/38 (28.95%)  8/34 (23.53%) 
vomiting  12/35 (34.29%)  10/38 (26.32%)  9/34 (26.47%) 
constipation  10/35 (28.57%)  10/38 (26.32%)  12/34 (35.29%) 
abdominal pain upper  3/35 (8.57%)  1/38 (2.63%)  4/34 (11.76%) 
abdominal pain  2/35 (5.71%)  6/38 (15.79%)  6/34 (17.65%) 
dysphagia  2/35 (5.71%)  2/38 (5.26%)  1/34 (2.94%) 
epigastric discomfort  2/35 (5.71%)  0/38 (0.00%)  1/34 (2.94%) 
gastrooesophageal reflux disease  2/35 (5.71%)  1/38 (2.63%)  1/34 (2.94%) 
gingival pain  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
glossodynia  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
haematochezia  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
oral pain  2/35 (5.71%)  3/38 (7.89%)  2/34 (5.88%) 
abdominal discomfort  1/35 (2.86%)  0/38 (0.00%)  3/34 (8.82%) 
lip pain  0/35 (0.00%)  2/38 (5.26%)  0/34 (0.00%) 
General disorders       
fatigue  25/35 (71.43%)  18/38 (47.37%)  15/34 (44.12%) 
pyrexia  23/35 (65.71%)  18/38 (47.37%)  15/34 (44.12%) 
chills  6/35 (17.14%)  12/38 (31.58%)  4/34 (11.76%) 
oedema peripheral  5/35 (14.29%)  6/38 (15.79%)  6/34 (17.65%) 
influenza like illness  3/35 (8.57%)  1/38 (2.63%)  0/34 (0.00%) 
asthenia  2/35 (5.71%)  4/38 (10.53%)  3/34 (8.82%) 
chest discomfort  2/35 (5.71%)  1/38 (2.63%)  1/34 (2.94%) 
chest pain  2/35 (5.71%)  1/38 (2.63%)  1/34 (2.94%) 
non-cardiac chest pain  2/35 (5.71%)  0/38 (0.00%)  3/34 (8.82%) 
pain  1/35 (2.86%)  2/38 (5.26%)  4/34 (11.76%) 
catheter site pain  0/35 (0.00%)  2/38 (5.26%)  0/34 (0.00%) 
pitting oedema  0/35 (0.00%)  2/38 (5.26%)  0/34 (0.00%) 
Infections and infestations       
cellulitis  4/35 (11.43%)  1/38 (2.63%)  0/34 (0.00%) 
pneumonia  4/35 (11.43%)  2/38 (5.26%)  3/34 (8.82%) 
oral candidiasis  2/35 (5.71%)  2/38 (5.26%)  2/34 (5.88%) 
upper respiratory tract infection  2/35 (5.71%)  3/38 (7.89%)  3/34 (8.82%) 
sepsis syndrome  0/35 (0.00%)  2/38 (5.26%)  0/34 (0.00%) 
urinary tract infection  3/35 (8.57%)  1/38 (2.63%)  2/34 (5.88%) 
Investigations       
alanine aminotransferase increased  4/35 (11.43%)  3/38 (7.89%)  4/34 (11.76%) 
alanine aminotransferase  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
aspartate aminotransferase increased  2/35 (5.71%)  3/38 (7.89%)  2/34 (5.88%) 
blood creatinine increased  2/35 (5.71%)  2/38 (5.26%)  2/34 (5.88%) 
cardiac murmur  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
platelet count decreased  2/35 (5.71%)  1/38 (2.63%)  2/34 (5.88%) 
weight decreased  2/35 (5.71%)  0/38 (0.00%)  1/34 (2.94%) 
white blood cell count  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
neutrophil count decreased  1/35 (2.86%)  6/38 (15.79%)  2/34 (5.88%) 
weight increased  0/35 (0.00%)  2/38 (5.26%)  1/34 (2.94%) 
white blood cell count decreased  1/35 (2.86%)  3/38 (7.89%)  1/34 (2.94%) 
blood lactate dehydrogenase increased  0/35 (0.00%)  2/38 (5.26%)  0/34 (0.00%) 
haemoglobin decreased  1/35 (2.86%)  5/38 (13.16%)  0/34 (0.00%) 
Metabolism and nutrition disorders       
decreased appetite  5/35 (14.29%)  3/38 (7.89%)  1/34 (2.94%) 
anorexia  3/35 (8.57%)  7/38 (18.42%)  5/34 (14.71%) 
hyperuricaemia  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
dehydration  1/35 (2.86%)  1/38 (2.63%)  3/34 (8.82%) 
hypocalcaemia  0/35 (0.00%)  2/38 (5.26%)  0/34 (0.00%) 
hypokalaemia  1/35 (2.86%)  1/38 (2.63%)  5/34 (14.71%) 
hypomagnesaemia  0/35 (0.00%)  2/38 (5.26%)  3/34 (8.82%) 
hyperglycaemia  0/35 (0.00%)  1/38 (2.63%)  2/34 (5.88%) 
hypoglycaemia  0/35 (0.00%)  0/38 (0.00%)  2/34 (5.88%) 
hyponatraemia  1/35 (2.86%)  4/38 (10.53%)  0/34 (0.00%) 
Musculoskeletal and connective tissue disorders       
back pain  5/35 (14.29%)  4/38 (10.53%)  3/34 (8.82%) 
muscular weakness  4/35 (11.43%)  2/38 (5.26%)  0/34 (0.00%) 
neck pain  3/35 (8.57%)  4/38 (10.53%)  2/34 (5.88%) 
myalgia  2/35 (5.71%)  1/38 (2.63%)  4/34 (11.76%) 
arthralgia  1/35 (2.86%)  3/38 (7.89%)  2/34 (5.88%) 
bone pain  1/35 (2.86%)  0/38 (0.00%)  2/34 (5.88%) 
muscle spasms  1/35 (2.86%)  3/38 (7.89%)  0/34 (0.00%) 
pain in extremity  1/35 (2.86%)  4/38 (10.53%)  6/34 (17.65%) 
musculoskeletal pain  3/35 (8.57%)  1/38 (2.63%)  3/34 (8.82%) 
groin pain  0/35 (0.00%)  2/38 (5.26%)  0/34 (0.00%) 
musculoskeletal chest pain  1/35 (2.86%)  0/38 (0.00%)  2/34 (5.88%) 
Nervous system disorders       
dizziness  8/35 (22.86%)  5/38 (13.16%)  8/34 (23.53%) 
paraesthesia  8/35 (22.86%)  0/38 (0.00%)  1/34 (2.94%) 
headache  7/35 (20.00%)  9/38 (23.68%)  6/34 (17.65%) 
neuropathy peripheral  4/35 (11.43%)  3/38 (7.89%)  2/34 (5.88%) 
hypoaesthesia  2/35 (5.71%)  2/38 (5.26%)  2/34 (5.88%) 
memory impairment  0/35 (0.00%)  1/38 (2.63%)  2/34 (5.88%) 
dysgeusia  0/35 (0.00%)  2/38 (5.26%)  1/34 (2.94%) 
Psychiatric disorders       
anxiety  3/35 (8.57%)  3/38 (7.89%)  1/34 (2.94%) 
insomnia  1/35 (2.86%)  1/38 (2.63%)  3/34 (8.82%) 
confusional state  0/35 (0.00%)  1/38 (2.63%)  2/34 (5.88%) 
Renal and urinary disorders       
renal failure acute  0/35 (0.00%)  2/38 (5.26%)  3/34 (8.82%) 
hydronephrosis  1/35 (2.86%)  0/38 (0.00%)  2/34 (5.88%) 
incontinence  0/35 (0.00%)  2/38 (5.26%)  0/34 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
dyspnoea  7/35 (20.00%)  5/38 (13.16%)  9/34 (26.47%) 
epistaxis  7/35 (20.00%)  2/38 (5.26%)  2/34 (5.88%) 
cough  6/35 (17.14%)  8/38 (21.05%)  2/34 (5.88%) 
wheezing  5/35 (14.29%)  0/38 (0.00%)  1/34 (2.94%) 
hypoxia  4/35 (11.43%)  2/38 (5.26%)  4/34 (11.76%) 
pharyngolaryngeal pain  4/35 (11.43%)  6/38 (15.79%)  4/34 (11.76%) 
pleural effusion  4/35 (11.43%)  2/38 (5.26%)  1/34 (2.94%) 
dysphonia  3/35 (8.57%)  2/38 (5.26%)  0/34 (0.00%) 
productive cough  3/35 (8.57%)  2/38 (5.26%)  0/34 (0.00%) 
pleuritic pain  2/35 (5.71%)  1/38 (2.63%)  1/34 (2.94%) 
pneumonitis  2/35 (5.71%)  1/38 (2.63%)  0/34 (0.00%) 
rhinitis allergic  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
dyspnoea exertional  1/35 (2.86%)  3/38 (7.89%)  0/34 (0.00%) 
nasal congestion  0/35 (0.00%)  1/38 (2.63%)  2/34 (5.88%) 
haemoptysis  1/35 (2.86%)  3/38 (7.89%)  1/34 (2.94%) 
rales  0/35 (0.00%)  2/38 (5.26%)  1/34 (2.94%) 
Skin and subcutaneous tissue disorders       
rash  5/35 (14.29%)  2/38 (5.26%)  2/34 (5.88%) 
alopecia  4/35 (11.43%)  2/38 (5.26%)  0/34 (0.00%) 
pruritus  4/35 (11.43%)  5/38 (13.16%)  5/34 (14.71%) 
erythema  3/35 (8.57%)  2/38 (5.26%)  2/34 (5.88%) 
night sweats  3/35 (8.57%)  5/38 (13.16%)  2/34 (5.88%) 
swelling face  2/35 (5.71%)  0/38 (0.00%)  0/34 (0.00%) 
rash pruritic  0/35 (0.00%)  7/38 (18.42%)  1/34 (2.94%) 
rash erythematous  0/35 (0.00%)  2/38 (5.26%)  0/34 (0.00%) 
rash maculo-papular  0/35 (0.00%)  2/38 (5.26%)  0/34 (0.00%) 
skin lesion  1/35 (2.86%)  1/38 (2.63%)  2/34 (5.88%) 
urticaria  1/35 (2.86%)  0/38 (0.00%)  2/34 (5.88%) 
Vascular disorders       
hypotension  6/35 (17.14%)  3/38 (7.89%)  3/34 (8.82%) 
flushing  2/35 (5.71%)  1/38 (2.63%)  2/34 (5.88%) 
hypertension  2/35 (5.71%)  1/38 (2.63%)  1/34 (2.94%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Saunders, MD
Organization: Allos Therapeutics, Inc.
Phone: 303-426-6262
EMail: msaunders@allos.com
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Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00481871     History of Changes
Other Study ID Numbers: PDX-009
First Submitted: June 1, 2007
First Posted: June 4, 2007
Results First Submitted: August 20, 2012
Results First Posted: September 18, 2012
Last Update Posted: May 10, 2013