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Trial record 7 of 48 for:    Dovitinib

Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib (SIGNATURE)

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ClinicalTrials.gov Identifier: NCT01831726
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tumor Pathway Activations Inhibited by Dovitinib
Intervention Drug: Dovitinib (TKI258)
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TKI258
Hide Arm/Group Description Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
Period Title: Overall Study
Started 80
Completed 0
Not Completed 80
Reason Not Completed
Adverse Event             16
Death             7
Disease Progression             49
Physician Decision             1
Subject/guardian decision             7
Arm/Group Title TKI258
Hide Arm/Group Description Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
58.3  (11.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
40
  50.0%
Male
40
  50.0%
1.Primary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description CBR determined by investigator assessment for each tumor assessment & defined as responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) ≥ 16 wks. Confirmed CR/PR or SD prior to 16 wks,but discontinued prior to 16 wks for reasons other than progressive disease,will have their clinical benefit defined non-evaluable; confirmed CR/PR or SD prior to 16 wks,but progressed prior to 16 wks,will be considered not achieving clinical benefit;if CR/PR/SD occurred prior to 16 wks,but progressed at or after 16 wks without evidence of CR/PR/SD at or after 16 wks,will also be considered not achieving clinical benefit. CBR will be analyzed by comparing achieved CBR with a historical control rate of each tumor type,& if there is at least 90% probability that the response rate in a tumor type exceeds the historical rate,then the tumor type will be considered a success. CBR: CR+PR+SD the assessment criteria was RECIST 1.1
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) included all patients who received at least one dose of study drug.

FAS was used for the analysis of efficacy endpoints.

Arm/Group Title TKI258
Hide Arm/Group Description:
Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: number of participants
Complete response (CR) 0
Partial response (PR) 1
Stable disease (SD) 10
Clinical benefit rate (CBR) 11
2.Secondary Outcome
Title Overall Response (OR) of Partial Response (PR) or Greater
Hide Description Overall Response (OR) of Partial Response (PR) or greater based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria will apply and are included in the appendices. ORR: CR+PR
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) included all patients who received at least one dose of study drug.

FAS was used for the analysis of efficacy endpoints.

Arm/Group Title TKI258
Hide Arm/Group Description:
Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: number of participants
Complete response (CR) 0
Partial response (PR) 1
Overall response rate (ORR) 1
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) included all patients who received at least one dose of study drug.

FAS was used for the analysis of efficacy endpoints.

Arm/Group Title TKI258
Hide Arm/Group Description:
Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
Overall Number of Participants Analyzed 80
Median (95% Confidence Interval)
Unit of Measure: months
2.4
(1.8 to 3.7)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) included all patients who received at least one dose of study drug.

FAS was used for the analysis of efficacy endpoints.

Arm/Group Title TKI258
Hide Arm/Group Description:
Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
Overall Number of Participants Analyzed 80
Median (95% Confidence Interval)
Unit of Measure: months
13.5
(5.9 to 14.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TKI258
Hide Arm/Group Description Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
All-Cause Mortality
TKI258
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TKI258
Affected / at Risk (%)
Total   32/80 (40.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/80 (1.25%) 
Febrile neutropenia  1  2/80 (2.50%) 
Neutropenia  1  1/80 (1.25%) 
Thrombocytopenia  1  2/80 (2.50%) 
Cardiac disorders   
Cardiac arrest  1  1/80 (1.25%) 
Gastrointestinal disorders   
Abdominal pain  1  2/80 (2.50%) 
Diarrhoea  1  1/80 (1.25%) 
Dysphagia  1  1/80 (1.25%) 
Gastrointestinal haemorrhage  1  1/80 (1.25%) 
Nausea  1  2/80 (2.50%) 
Small intestinal obstruction  1  1/80 (1.25%) 
Stomatitis  1  1/80 (1.25%) 
Vomiting  1  5/80 (6.25%) 
General disorders   
Chest pain  1  2/80 (2.50%) 
Fatigue  1  1/80 (1.25%) 
Pyrexia  1  2/80 (2.50%) 
Hepatobiliary disorders   
Bile duct obstruction  1  1/80 (1.25%) 
Gallbladder obstruction  1  1/80 (1.25%) 
Infections and infestations   
Cellulitis  1  1/80 (1.25%) 
Peritonitis  1  1/80 (1.25%) 
Pneumonia  1  1/80 (1.25%) 
Urinary tract infection  1  1/80 (1.25%) 
Wound infection  1  1/80 (1.25%) 
Injury, poisoning and procedural complications   
Spinal fracture  1  1/80 (1.25%) 
Subdural haematoma  1  1/80 (1.25%) 
Investigations   
Blood alkaline phosphatase increased  1  1/80 (1.25%) 
Blood bilirubin increased  1  2/80 (2.50%) 
Platelet count decreased  1  1/80 (1.25%) 
Metabolism and nutrition disorders   
Dehydration  1  4/80 (5.00%) 
Hyponatraemia  1  1/80 (1.25%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/80 (1.25%) 
Neck pain  1  1/80 (1.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma  1  1/80 (1.25%) 
Nervous system disorders   
Cerebral thrombosis  1  1/80 (1.25%) 
Encephalopathy  1  1/80 (1.25%) 
Lethargy  1  1/80 (1.25%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/80 (1.25%) 
Cough  1  1/80 (1.25%) 
Dyspnoea  1  2/80 (2.50%) 
Pleural effusion  1  1/80 (1.25%) 
Pneumothorax  1  1/80 (1.25%) 
Pulmonary embolism  1  4/80 (5.00%) 
Skin and subcutaneous tissue disorders   
Angioedema  1  1/80 (1.25%) 
Vascular disorders   
Deep vein thrombosis  1  1/80 (1.25%) 
Hypertension  1  1/80 (1.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TKI258
Affected / at Risk (%)
Total   78/80 (97.50%) 
Blood and lymphatic system disorders   
Anaemia  1  8/80 (10.00%) 
Lymphopenia  1  4/80 (5.00%) 
Thrombocytopenia  1  8/80 (10.00%) 
Cardiac disorders   
Sinus tachycardia  1  4/80 (5.00%) 
Eye disorders   
Lacrimation increased  1  5/80 (6.25%) 
Gastrointestinal disorders   
Abdominal pain  1  12/80 (15.00%) 
Abdominal pain upper  1  4/80 (5.00%) 
Constipation  1  26/80 (32.50%) 
Diarrhoea  1  51/80 (63.75%) 
Dry mouth  1  6/80 (7.50%) 
Dyspepsia  1  8/80 (10.00%) 
Dysphagia  1  4/80 (5.00%) 
Gastrooesophageal reflux disease  1  4/80 (5.00%) 
Haemorrhoids  1  4/80 (5.00%) 
Nausea  1  47/80 (58.75%) 
Vomiting  1  35/80 (43.75%) 
General disorders   
Asthenia  1  13/80 (16.25%) 
Fatigue  1  56/80 (70.00%) 
Mucosal inflammation  1  4/80 (5.00%) 
Oedema peripheral  1  5/80 (6.25%) 
Pain  1  7/80 (8.75%) 
Pyrexia  1  7/80 (8.75%) 
Infections and infestations   
Pneumonia  1  4/80 (5.00%) 
Upper respiratory tract infection  1  7/80 (8.75%) 
Urinary tract infection  1  7/80 (8.75%) 
Investigations   
Alanine aminotransferase increased  1  16/80 (20.00%) 
Amylase increased  1  8/80 (10.00%) 
Aspartate aminotransferase increased  1  19/80 (23.75%) 
Blood alkaline phosphatase increased  1  23/80 (28.75%) 
Blood bilirubin increased  1  7/80 (8.75%) 
Blood creatinine increased  1  4/80 (5.00%) 
Gamma-glutamyltransferase increased  1  17/80 (21.25%) 
Lipase increased  1  8/80 (10.00%) 
Platelet count decreased  1  4/80 (5.00%) 
Weight decreased  1  18/80 (22.50%) 
White blood cell count decreased  1  6/80 (7.50%) 
Metabolism and nutrition disorders   
Decreased appetite  1  34/80 (42.50%) 
Dehydration  1  17/80 (21.25%) 
Hypercholesterolaemia  1  5/80 (6.25%) 
Hyperglycaemia  1  6/80 (7.50%) 
Hyperkalaemia  1  4/80 (5.00%) 
Hypertriglyceridaemia  1  27/80 (33.75%) 
Hypoalbuminaemia  1  8/80 (10.00%) 
Hypocalcaemia  1  5/80 (6.25%) 
Hypokalaemia  1  4/80 (5.00%) 
Hypomagnesaemia  1  9/80 (11.25%) 
Hyponatraemia  1  12/80 (15.00%) 
Hypophosphataemia  1  4/80 (5.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  6/80 (7.50%) 
Back pain  1  12/80 (15.00%) 
Muscular weakness  1  6/80 (7.50%) 
Musculoskeletal pain  1  5/80 (6.25%) 
Myalgia  1  6/80 (7.50%) 
Pain in extremity  1  9/80 (11.25%) 
Nervous system disorders   
Dizziness  1  10/80 (12.50%) 
Dysgeusia  1  9/80 (11.25%) 
Headache  1  15/80 (18.75%) 
Neuropathy peripheral  1  5/80 (6.25%) 
Psychiatric disorders   
Anxiety  1  4/80 (5.00%) 
Insomnia  1  4/80 (5.00%) 
Renal and urinary disorders   
Proteinuria  1  4/80 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  14/80 (17.50%) 
Dyspnoea  1  19/80 (23.75%) 
Skin and subcutaneous tissue disorders   
Dermatitis acneiform  1  4/80 (5.00%) 
Dry skin  1  5/80 (6.25%) 
Night sweats  1  4/80 (5.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  6/80 (7.50%) 
Pruritus  1  8/80 (10.00%) 
Rash  1  11/80 (13.75%) 
Rash maculo-papular  1  6/80 (7.50%) 
Vascular disorders   
Hypertension  1  14/80 (17.50%) 
Hypotension  1  8/80 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v18.0
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01831726     History of Changes
Other Study ID Numbers: CTKI258AUS26
First Submitted: April 11, 2013
First Posted: April 15, 2013
Results First Submitted: January 30, 2017
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017