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Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT00072475
Recruitment Status : Completed
First Posted : November 6, 2003
Results First Posted : June 24, 2014
Last Update Posted : August 1, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Intervention Drug: vatalanib
Enrollment 155
Recruitment Details A total of 155 participants were enrolled between December 2003 and April 2008.
Pre-assignment Details Of the 155 participants recruited, 2 participants cancelled prior to starting treatment; 7 were determined to have AML at registration and 4 had diagnosis other than MDS. Thus 142 participants were evaluable for response and 153 for adverse events.
Arm/Group Title Vatalanib
Hide Arm/Group Description

Adult patients with MDS receive treatment with vatalanib.

vatalanib: Pts registered before 1/15/05 1250 mg/day PO

After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

Period Title: Overall Study
Started 142
Completed 45
Not Completed 97
Reason Not Completed
Adverse Event             44
Death             3
Withdrawal by Subject             46
Patient/Investigator Decision             4
Arm/Group Title Vatalanib
Hide Arm/Group Description

Adult patients with MDS receive treatment with vatalanib.

vatalanib: Pts registered before 1/15/05 1250 mg/day PO

After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

Overall Number of Baseline Participants 142
Hide Baseline Analysis Population Description
Of the 155 participants recruited, 2 participants cancelled prior to starting treatment; 7 were determined to have AML at registration and 4 had diagnosis other than MDS. Thus 142 participants were evaluable for response
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 142 participants
71
(27 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants
Female
52
  36.6%
Male
90
  63.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   2.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   2.8%
White
133
  93.7%
More than one race
1
   0.7%
Unknown or Not Reported
1
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 142 participants
142
1.Primary Outcome
Title Number of Participants With Response
Hide Description

Response was measured by International Standardized Response Criteria for MDS

  • Complete Response: Bone marrow showing < 5% myeloblasts with normal maturation of all cell lines; Hgb > 11 g/dL (untransfused), ANC ≥1.5 K/L, PLT ≥ 100 K/L, No blasts, no dysplasia
  • Partial remission: All of the CR criteria (if abnormal at baseline), except BM evaluation. Blasts decreased by ≥ 50% over baseline. Cellularity and morphology are not relevant.

Hematologic improvement:

  • Erythroid (HI-E): For participants with baseline HGB < 11g/dL, Major: > 2g/dL increase, transfusion independence. Minor: 1-2g/dL increase, ≥ 50% decrease in transfusion requirements
  • Platelet (HI-P): For participants with baseline PLT < 100 K/L: Major: absolute increase of > 30 K/L, transfusion independence. Minor: ≥ 50% increase (net increase of >10 K/L)
  • Neutrophil (HI-N): For participants with baseline ANC < 1.5 K/L, Major: > 100% increase (net increase > 0.5 K/L). Minor: > 100% increase (absolute increase < 0.5 K/L)
Time Frame Duration of study (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vatalanib
Hide Arm/Group Description:

Adult patients with MDS receive treatment with vatalanib.

vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

Overall Number of Participants Analyzed 142
Measure Type: Number
Unit of Measure: participants
Complete Remission 0
Partial Remission 0
HI-E Major 3
HI-E Minor 1
HI-P Major 2
HI-P Minor 1
HI-N Major 0
HI-N Minor 0
2.Primary Outcome
Title Time to Transformation to AML
Hide Description Time to transformation to AML is defined as the time from registration to the transformation of MDS to AML or death of any cause. Participants not meeting these criteria were censored at the date of last follow-up. This outcome was estimated using the Kaplan Meier method.
Time Frame Duration of study (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vatalanib
Hide Arm/Group Description:

Adult patients with MDS receive treatment with vatalanib.

vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

Overall Number of Participants Analyzed 142
Median (95% Confidence Interval)
Unit of Measure: months
17.2
(10.8 to 23.9)
3.Secondary Outcome
Title Duration of Response
Hide Description

Duration of response (DOR) was defined as the time from response (complete remission, partial remission or hematologic improvement) to progression or death of any cause. Responding and alive patients were censored at the date of last follow-up. The median DOR with 95% CI was estimated using the Kaplan Meier method.

Response was measured by International Standardized Response Criteria for MDS (described in above outcome measure).

Time Frame 5 yrs
Hide Outcome Measure Data
Hide Analysis Population Description
Per the description, only patients who achieved a response were evaluable for this outcome.
Arm/Group Title Vatalanib
Hide Arm/Group Description:

Adult patients with MDS receive treatment with vatalanib.

vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

Overall Number of Participants Analyzed 7
Median (95% Confidence Interval)
Unit of Measure: months
6
(2 to 46)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.
Time Frame Duration of study (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vatalanib
Hide Arm/Group Description:

Adult patients with MDS receive treatment with vatalanib.

vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

Overall Number of Participants Analyzed 142
Median (95% Confidence Interval)
Unit of Measure: months
18.9
(15.0 to 26.8)
5.Secondary Outcome
Title Progression-free Survival
Hide Description

Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last clinical assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.

Progression is defined as

  • For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts
  • For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts
  • For patients with 10-19% bone marrow blasts: increase to ≥20% blasts
  • One or more of the following: 50% or greater decrement from maximum remission/response levels in ANC < 1.5 K/L or PLT< 100 K/L, or reduction in HGB by at least 2 g/dL or becoming transfusion dependent

Progression after HI: Includes one or more of the following

  • Decrement of 50% or greater from maximum response levels in ANC < 1.5 K/L or PLT < 100 K/L
  • Reduction in HGB concentration by at least 2 g/dL
  • Becoming transfusion dependent
Time Frame Duration of study (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vatalanib
Hide Arm/Group Description:

Adult patients with MDS receive treatment with vatalanib.

vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

Overall Number of Participants Analyzed 142
Median (95% Confidence Interval)
Unit of Measure: months
10.2
(7.4 to 14.74)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vatalanib
Hide Arm/Group Description After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
All-Cause Mortality
Vatalanib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vatalanib
Affected / at Risk (%) # Events
Total   51/153 (33.33%)    
Blood and lymphatic system disorders   
Disseminated intravascular coagulation  1  1/153 (0.65%)  1
Febrile neutropenia  1  7/153 (4.58%)  8
Hemoglobin decreased  1  43/153 (28.10%)  48
Hemolysis  1  1/153 (0.65%)  1
Cardiac disorders   
Arrhythmia supraventricular  1  1/153 (0.65%)  1
Atrial fibrillation  1  1/153 (0.65%)  1
Pericardial effusion  1  1/153 (0.65%)  1
Sinus tachycardia  1  1/153 (0.65%)  1
Ear and labyrinth disorders   
Tinnitus  1  1/153 (0.65%)  1
Eye disorders   
Vision blurred  1  2/153 (1.31%)  2
Gastrointestinal disorders   
Abdominal pain  1  4/153 (2.61%)  4
Ascites  1  1/153 (0.65%)  1
Colonic hemorrhage  1  1/153 (0.65%)  1
Constipation  1  3/153 (1.96%)  3
Diarrhea  1  21/153 (13.73%)  23
Duodenal hemorrhage  1  1/153 (0.65%)  1
Dyspepsia  1  5/153 (3.27%)  6
Ear, nose and throat examination abnormal  1  2/153 (1.31%)  2
Esophageal hemorrhage  1  1/153 (0.65%)  1
Esophagitis  1  1/153 (0.65%)  1
Flatulence  1  1/153 (0.65%)  1
Gastritis  1  3/153 (1.96%)  3
Gastrointestinal disorder  1  4/153 (2.61%)  4
Lower gastrointestinal hemorrhage  1  1/153 (0.65%)  1
Mucositis oral  1  2/153 (1.31%)  2
Nausea  1  30/153 (19.61%)  33
Oral hemorrhage  1  1/153 (0.65%)  1
Oral pain  1  1/153 (0.65%)  1
Pancreatitis  1  1/153 (0.65%)  1
Rectal hemorrhage  1  2/153 (1.31%)  2
Small intestinal obstruction  1  2/153 (1.31%)  2
Vomiting  1  28/153 (18.30%)  31
General disorders   
Chest pain  1  2/153 (1.31%)  2
Chills  1  5/153 (3.27%)  5
Death NOS  1  2/153 (1.31%)  2
Edema limbs  1  5/153 (3.27%)  6
Fatigue  1  35/153 (22.88%)  41
Fever  1  8/153 (5.23%)  8
Hypothermia  1  1/153 (0.65%)  1
Localized edema  1  1/153 (0.65%)  1
Pain  1  3/153 (1.96%)  4
Sudden death  1  1/153 (0.65%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/153 (0.65%)  1
Gallbladder pain  1  1/153 (0.65%)  1
Immune system disorders   
Hypersensitivity  1  1/153 (0.65%)  1
Infections and infestations   
Bladder infection  1  1/153 (0.65%)  1
Catheter related infection  1  1/153 (0.65%)  1
Duodenal infection  1  1/153 (0.65%)  1
Gingival infection  1  1/153 (0.65%)  1
Infection  1  1/153 (0.65%)  1
Infection without neutropenia  1  2/153 (1.31%)  2
Sepsis  1  2/153 (1.31%)  2
Skin infection  1  1/153 (0.65%)  1
Tooth infection  1  1/153 (0.65%)  1
Upper respiratory infection  1  2/153 (1.31%)  2
Urinary tract infection  1  1/153 (0.65%)  1
Vaginal infection  1  1/153 (0.65%)  1
Injury, poisoning and procedural complications   
Bruising  1  1/153 (0.65%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  3/153 (1.96%)  3
Alanine aminotransferase increased  1  10/153 (6.54%)  11
Alkaline phosphatase  1  1/153 (0.65%)  1
Alkaline phosphatase increased  1  7/153 (4.58%)  7
Aspartate aminotransferase increased  1  12/153 (7.84%)  13
Blood bilirubin increased  1  6/153 (3.92%)  6
Cardiac troponin I increased  1  1/153 (0.65%)  1
Coagulopathy  1  1/153 (0.65%)  1
Creatinine increased  1  7/153 (4.58%)  8
Electrocardiogram QTc interval prolonged  1  1/153 (0.65%)  1
Gamma-glutamyltransferase increased  1  2/153 (1.31%)  2
INR increased  1  2/153 (1.31%)  2
Laboratory test abnormal  1  2/153 (1.31%)  2
Leukocyte count decreased  1  6/153 (3.92%)  6
Lymphocyte count decreased  1  2/153 (1.31%)  2
Neutrophil count decreased  1  26/153 (16.99%)  30
Platelet count decreased  1  41/153 (26.80%)  47
Serum cholesterol increased  1  1/153 (0.65%)  1
Weight gain  1  1/153 (0.65%)  1
Weight loss  1  5/153 (3.27%)  5
Metabolism and nutrition disorders   
Anorexia  1  11/153 (7.19%)  12
Blood glucose increased  1  13/153 (8.50%)  16
Blood uric acid increased  1  2/153 (1.31%)  2
Dehydration  1  8/153 (5.23%)  9
Serum albumin decreased  1  9/153 (5.88%)  9
Serum calcium decreased  1  12/153 (7.84%)  13
Serum calcium increased  1  1/153 (0.65%)  1
Serum glucose decreased  1  3/153 (1.96%)  4
Serum magnesium decreased  1  4/153 (2.61%)  6
Serum magnesium increased  1  2/153 (1.31%)  2
Serum phosphate decreased  1  3/153 (1.96%)  3
Serum potassium decreased  1  7/153 (4.58%)  8
Serum potassium increased  1  3/153 (1.96%)  3
Serum sodium decreased  1  8/153 (5.23%)  9
Serum sodium increased  1  3/153 (1.96%)  3
Serum triglycerides increased  1  2/153 (1.31%)  3
Musculoskeletal and connective tissue disorders   
Arthralgia  1  4/153 (2.61%)  4
Arthritis  1  1/153 (0.65%)  2
Chest wall pain  1  2/153 (1.31%)  2
Muscle weakness  1  4/153 (2.61%)  4
Muscle weakness lower limb  1  1/153 (0.65%)  1
Neck pain  1  1/153 (0.65%)  1
Pain in extremity  1  4/153 (2.61%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Treatment related secondary malignancy  1  1/153 (0.65%)  1
Nervous system disorders   
Ataxia  1  6/153 (3.92%)  6
Depressed level of consciousness  1  1/153 (0.65%)  1
Dizziness  1  14/153 (9.15%)  14
Extrapyramidal disorder  1  2/153 (1.31%)  2
Headache  1  10/153 (6.54%)  10
Ischemia cerebrovascular  1  3/153 (1.96%)  3
Neurological disorder NOS  1  2/153 (1.31%)  2
Peripheral motor neuropathy  1  1/153 (0.65%)  1
Peripheral sensory neuropathy  1  1/153 (0.65%)  1
Speech disorder  1  2/153 (1.31%)  2
Syncope  1  2/153 (1.31%)  2
Tremor  1  1/153 (0.65%)  1
Psychiatric disorders   
Agitation  1  1/153 (0.65%)  1
Anxiety  1  2/153 (1.31%)  2
Confusion  1  7/153 (4.58%)  7
Depression  1  2/153 (1.31%)  3
Insomnia  1  2/153 (1.31%)  2
Renal and urinary disorders   
Bladder pain  1  1/153 (0.65%)  1
Hemorrhage urinary tract  1  4/153 (2.61%)  4
Proteinuria  1  10/153 (6.54%)  12
Renal failure  1  1/153 (0.65%)  1
Urinary frequency  1  1/153 (0.65%)  1
Urinary incontinence  1  2/153 (1.31%)  2
Urinary retention  1  1/153 (0.65%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  2/153 (1.31%)  2
Cough  1  8/153 (5.23%)  8
Dyspnea  1  11/153 (7.19%)  11
Dyspnea (shortness of breath)  1  1/153 (0.65%)  1
Epistaxis  1  8/153 (5.23%)  9
Hypoxia  1  1/153 (0.65%)  1
Pharyngeal examination abnormal  1  2/153 (1.31%)  2
Pharyngolaryngeal pain  1  1/153 (0.65%)  1
Pleural effusion  1  1/153 (0.65%)  1
Pleuritic pain  1  1/153 (0.65%)  1
Pneumonitis  1  2/153 (1.31%)  2
Respiratory tract hemorrhage  1  1/153 (0.65%)  1
Tracheoscopy abnormal  1  1/153 (0.65%)  1
Voice alteration  1  3/153 (1.96%)  3
Skin and subcutaneous tissue disorders   
Dry skin  1  1/153 (0.65%)  1
Hand-and-foot syndrome  1  1/153 (0.65%)  1
Petechiae  1  3/153 (1.96%)  3
Photosensitivity  1  1/153 (0.65%)  1
Pigmentation changes (e.g., vitiligo)  1  1/153 (0.65%)  1
Pruritus  1  2/153 (1.31%)  2
Rash desquamating  1  3/153 (1.96%)  3
Skin disorder  1  1/153 (0.65%)  1
Sweating  1  3/153 (1.96%)  3
Vascular disorders   
Hematoma  1  1/153 (0.65%)  1
Hemorrhage  1  1/153 (0.65%)  1
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia  1  1/153 (0.65%)  1
Hypertension  1  7/153 (4.58%)  9
Hypotension  1  5/153 (3.27%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vatalanib
Affected / at Risk (%) # Events
Total   134/153 (87.58%)    
Blood and lymphatic system disorders   
Blood disorder  1  1/153 (0.65%)  2
Febrile neutropenia  1  12/153 (7.84%)  12
Hemoglobin decreased  1  121/153 (79.08%)  324
Hemolysis  1  1/153 (0.65%)  1
Spleen disorder  1  1/153 (0.65%)  1
Transfusion: pRBCs for pediatric BMT studies, if specified in the protocol.  1  1/153 (0.65%)  1
Cardiac disorders   
Arrhythmia  1  1/153 (0.65%)  1
Atrial flutter  1  1/153 (0.65%)  1
Cardiac disorder  1  2/153 (1.31%)  2
Conduction disorder  1  1/153 (0.65%)  1
Left ventricular failure  1  4/153 (2.61%)  4
Myocardial ischemia  1  2/153 (1.31%)  2
Palpitations  1  4/153 (2.61%)  6
Sinus tachycardia  1  3/153 (1.96%)  3
Ventricular tachycardia  1  1/153 (0.65%)  1
Ear and labyrinth disorders   
External ear inflammation  1  1/153 (0.65%)  1
Tinnitus  1  1/153 (0.65%)  3
Endocrine disorders   
Endocrine disorder  1  2/153 (1.31%)  2
Hypothyroidism  1  2/153 (1.31%)  2
Eye disorders   
Diplopia  1  1/153 (0.65%)  1
Eye disorder  1  2/153 (1.31%)  2
Eye pain  1  1/153 (0.65%)  1
Flashing vision  1  2/153 (1.31%)  2
Glaucoma  1  1/153 (0.65%)  1
Vision blurred  1  2/153 (1.31%)  2
Gastrointestinal disorders   
Abdominal pain  1  4/153 (2.61%)  4
Anal hemorrhage  1  1/153 (0.65%)  1
Cheilitis  1  1/153 (0.65%)  1
Colitis  1  1/153 (0.65%)  1
Constipation  1  23/153 (15.03%)  28
Diarrhea  1  45/153 (29.41%)  71
Dry mouth  1  3/153 (1.96%)  3
Dyspepsia  1  8/153 (5.23%)  9
Dysphagia  1  2/153 (1.31%)  2
Ear, nose and throat examination abnormal  1  7/153 (4.58%)  8
Esophageal mucositis  1  1/153 (0.65%)  1
Esophagitis  1  1/153 (0.65%)  1
Flatulence  1  1/153 (0.65%)  1
Gastric hemorrhage  1  3/153 (1.96%)  3
Gastrointestinal disorder  1  6/153 (3.92%)  8
Hemorrhoids  1  3/153 (1.96%)  4
Lower gastrointestinal hemorrhage  1  2/153 (1.31%)  2
Mucositis oral  1  6/153 (3.92%)  6
Nausea  1  80/153 (52.29%)  135
Oral hemorrhage  1  1/153 (0.65%)  1
Oral pain  1  2/153 (1.31%)  2
Proctitis  1  1/153 (0.65%)  1
Rectal hemorrhage  1  1/153 (0.65%)  1
Stomach pain  1  2/153 (1.31%)  2
Toothache  1  3/153 (1.96%)  3
Vomiting  1  52/153 (33.99%)  70
General disorders   
Chest pain  1  4/153 (2.61%)  4
Chills  1  6/153 (3.92%)  8
Death NOS  1  2/153 (1.31%)  2
Edema limbs  1  15/153 (9.80%)  21
Fatigue  1  116/153 (75.82%)  233
Fever  1  12/153 (7.84%)  16
Gait abnormal  1  1/153 (0.65%)  2
Injection site reaction  1  1/153 (0.65%)  1
Pain  1  11/153 (7.19%)  13
Visceral edema  1  1/153 (0.65%)  2
Immune system disorders   
Hypersensitivity  1  1/153 (0.65%)  1
Immune system disorder  1  1/153 (0.65%)  1
Infections and infestations   
Bladder infection  1  1/153 (0.65%)  1
Bronchitis  1  1/153 (0.65%)  1
Catheter related infection  1  2/153 (1.31%)  2
Duodenal infection  1  1/153 (0.65%)  1
Esophageal infection  1  1/153 (0.65%)  1
Infection  1  5/153 (3.27%)  5
Infection with grade 3 or 4 neutropenia  1  1/153 (0.65%)  1
Infection without neutropenia  1  1/153 (0.65%)  1
Mucosal infection  1  1/153 (0.65%)  1
Opportunistic infection  1  1/153 (0.65%)  1
Otitis media  1  1/153 (0.65%)  1
Pneumonia  1  6/153 (3.92%)  6
Rhinitis infective  1  1/153 (0.65%)  1
Sepsis  1  2/153 (1.31%)  2
Sinusitis  1  3/153 (1.96%)  3
Skin infection  1  3/153 (1.96%)  3
Soft tissue infection  1  1/153 (0.65%)  1
Tooth infection  1  3/153 (1.96%)  3
Upper respiratory infection  1  4/153 (2.61%)  5
Urinary tract infection  1  2/153 (1.31%)  2
Injury, poisoning and procedural complications   
Bruising  1  7/153 (4.58%)  7
Fracture  1  1/153 (0.65%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  3/153 (1.96%)  6
Alanine aminotransferase increased  1  27/153 (17.65%)  41
Alkaline phosphatase increased  1  13/153 (8.50%)  18
Aspartate aminotransferase increased  1  25/153 (16.34%)  36
Blood bilirubin increased  1  8/153 (5.23%)  12
Coagulopathy  1  2/153 (1.31%)  3
Creatinine increased  1  9/153 (5.88%)  14
Electrocardiogram QTc interval prolonged  1  1/153 (0.65%)  1
Gamma-glutamyltransferase increased  1  3/153 (1.96%)  3
INR increased  1  3/153 (1.96%)  4
Laboratory test abnormal  1  7/153 (4.58%)  8
Leukocyte count decreased  1  15/153 (9.80%)  29
Lipase increased  1  1/153 (0.65%)  1
Lymphocyte count decreased  1  2/153 (1.31%)  3
Neutrophil count decreased  1  88/153 (57.52%)  198
Pancreatic enzymes decreased  1  1/153 (0.65%)  1
Platelet count decreased  1  100/153 (65.36%)  226
Serum cholesterol increased  1  4/153 (2.61%)  7
Weight gain  1  1/153 (0.65%)  1
Weight loss  1  15/153 (9.80%)  15
Metabolism and nutrition disorders   
Anorexia  1  26/153 (16.99%)  36
Blood glucose increased  1  37/153 (24.18%)  70
Blood uric acid increased  1  1/153 (0.65%)  2
Dehydration  1  3/153 (1.96%)  3
Iron overload  1  3/153 (1.96%)  4
Serum albumin decreased  1  12/153 (7.84%)  15
Serum calcium decreased  1  11/153 (7.19%)  16
Serum calcium increased  1  2/153 (1.31%)  3
Serum glucose decreased  1  5/153 (3.27%)  5
Serum magnesium decreased  1  3/153 (1.96%)  3
Serum magnesium increased  1  2/153 (1.31%)  3
Serum potassium decreased  1  7/153 (4.58%)  8
Serum potassium increased  1  3/153 (1.96%)  3
Serum sodium decreased  1  7/153 (4.58%)  9
Serum sodium increased  1  2/153 (1.31%)  2
Serum triglycerides increased  1  7/153 (4.58%)  7
Musculoskeletal and connective tissue disorders   
Arthralgia  1  10/153 (6.54%)  16
Arthritis  1  2/153 (1.31%)  2
Back pain  1  10/153 (6.54%)  14
Bone pain  1  5/153 (3.27%)  5
Chest wall pain  1  3/153 (1.96%)  3
Muscle weakness  1  5/153 (3.27%)  9
Muscle weakness upper limb  1  1/153 (0.65%)  1
Musculoskeletal disorder  1  6/153 (3.92%)  6
Myalgia  1  9/153 (5.88%)  9
Pain in extremity  1  5/153 (3.27%)  8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Myelodysplasia  1  1/153 (0.65%)  1
Nervous system disorders   
Ataxia  1  15/153 (9.80%)  17
Cognitive disturbance  1  1/153 (0.65%)  1
Dizziness  1  60/153 (39.22%)  82
Dysgeusia  1  2/153 (1.31%)  2
Extrapyramidal disorder  1  1/153 (0.65%)  1
Headache  1  19/153 (12.42%)  22
Intracranial hemorrhage  1  1/153 (0.65%)  1
Memory impairment  1  3/153 (1.96%)  5
Mini mental status examination abnormal  1  1/153 (0.65%)  1
Neuralgia  1  1/153 (0.65%)  2
Neurological disorder NOS  1  3/153 (1.96%)  3
Peripheral motor neuropathy  1  5/153 (3.27%)  6
Peripheral sensory neuropathy  1  11/153 (7.19%)  16
Speech disorder  1  2/153 (1.31%)  2
Syncope  1  1/153 (0.65%)  1
Tremor  1  3/153 (1.96%)  4
Vagus nerve disorder  1  1/153 (0.65%)  2
Psychiatric disorders   
Agitation  1  1/153 (0.65%)  1
Anxiety  1  3/153 (1.96%)  3
Confusion  1  5/153 (3.27%)  6
Depression  1  3/153 (1.96%)  3
Euphoria  1  2/153 (1.31%)  2
Insomnia  1  9/153 (5.88%)  12
Renal and urinary disorders   
Cystitis  1  2/153 (1.31%)  2
Hemorrhage urinary tract  1  2/153 (1.31%)  4
Kidney pain  1  1/153 (0.65%)  1
Proteinuria  1  30/153 (19.61%)  47
Urinary frequency  1  2/153 (1.31%)  2
Urinary incontinence  1  1/153 (0.65%)  1
Urine discoloration  1  1/153 (0.65%)  1
Urogenital disorder  1  2/153 (1.31%)  2
Reproductive system and breast disorders   
Scrotal pain  1  1/153 (0.65%)  1
Vaginal hemorrhage  1  1/153 (0.65%)  1
Vaginal inflammation  1  1/153 (0.65%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  5/153 (3.27%)  6
Bronchospasm  1  1/153 (0.65%)  1
Cough  1  19/153 (12.42%)  27
Dyspnea  1  37/153 (24.18%)  51
Dyspnea (shortness of breath)  1  4/153 (2.61%)  4
Epistaxis  1  14/153 (9.15%)  18
Hemoptysis  1  1/153 (0.65%)  1
Hypoxia  1  1/153 (0.65%)  1
Pharyngolaryngeal pain  1  2/153 (1.31%)  2
Pleural effusion  1  1/153 (0.65%)  1
Pneumonitis  1  4/153 (2.61%)  4
Respiratory disorder  1  3/153 (1.96%)  3
Respiratory tract hemorrhage  1  1/153 (0.65%)  1
Voice alteration  1  4/153 (2.61%)  6
Skin and subcutaneous tissue disorders   
Alopecia  1  1/153 (0.65%)  1
Dry skin  1  6/153 (3.92%)  6
Petechiae  1  6/153 (3.92%)  7
Pruritus  1  6/153 (3.92%)  7
Rash desquamating  1  20/153 (13.07%)  25
Skin disorder  1  9/153 (5.88%)  9
Sweating  1  6/153 (3.92%)  7
Urticaria  1  3/153 (1.96%)  3
Vascular disorders   
Hematoma  1  3/153 (1.96%)  4
Hot flashes  1  1/153 (0.65%)  1
Hypertension  1  10/153 (6.54%)  15
Hypotension  1  4/153 (2.61%)  4
Thrombosis  1  2/153 (1.31%)  3
Vascular disorder  1  2/153 (1.31%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pankaj Gupta, M.D.
Organization: University of Minnesota
EMail: gupta013@umn.edu
Publications of Results:
Gupta P, Miller AA, Owzar K, et al.: Pharmacokinetics of an oral VEGF receptor tyrosine kinase inhibitor (PTK787/ZK222584) in patients with myelodysplastic syndrome (MDS): Cancer and Leukemia Group B study 10105. [Abstract] J Clin Oncol 24 (Suppl 18): A-6573, 355s, 2006.
Gupta P, Sanford BL, Yu D, et al.: A phase II study of an oral VEGF receptor tyrosine kinase inhibitor (PTK787/ZK222584) in patients with myelodysplastic syndrome (MDS): Cancer and Leukemia Group B study 10105. [Abstract] Blood 108 (11): A-2665, 2006.
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00072475     History of Changes
Other Study ID Numbers: CALGB-10105
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-10105
CDR0000339810 ( Registry Identifier: NCI Physician Data Query )
First Submitted: November 4, 2003
First Posted: November 6, 2003
Results First Submitted: May 22, 2014
Results First Posted: June 24, 2014
Last Update Posted: August 1, 2016