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Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma

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: NCT00798096
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : June 12, 2014
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition T Cell Lymphoma
Intervention Drug: Fostamatinib Disodium
Enrollment 18
Recruitment Details A total of 18 patients with T-Cell lymphoid malignancy were enrolled in this study from 05 March 2009 until 04 January 2010. As of 19 May 2010, no patients remain on study. All enrolled patients received at least one dose of fostamatinib. This study was conducted at 9 sites in the U.S. and Canada.
Pre-assignment Details There was a screening period of up to 28 days, after which if all inclusion/exclusion criteria were met, patients were dosed with fostamatinib treatment for a treatment period of 8 weeks. Patients could continue treatment until disease progression, toxicity or withdrawal from the study
Arm/Group Title Overall Study
Hide Arm/Group Description 1-fostamatinib 200mg, BID, Oral
Period Title: Overall Study
Started 18 [1]
Completed 16 [2]
Not Completed 2
Reason Not Completed
Ongoing             2
[1]
Treatment with 200 mg bid, oral Fostamatanib until disease progression, toxicity or withdrawal
[2]
Completion of Study is defined as a minimum of 8 weeks of treatment or early disease progression
Arm/Group Title Overall Study
Hide Arm/Group Description 1-fostamatinib 200mg, BID, Oral
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
68.5  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
8
  44.4%
Male
10
  55.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 18 participants
Asian 2
White 15
Other - Unknown 1
1.Primary Outcome
Title The Primary Efficacy Endpoint for This Study is Overall Regressive Response Rate (ORRR): Proportion of Patients With a Best Response of Complete Response (CR), Partial Response (PR), or Regressive Stable Disease (RSD).
Hide Description Overall regressive response rate (ORRR) is the proportion of patients with a best response of Complete Response (CR), Partial Response (PR) (per Cheson 2007), or Regressive Stable Disease (RSD) defined as regressive disease that does not meet the criteria for partial response.
Time Frame Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
1-fostamatinib 200mg, BID, Oral
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Participants
4
2.Secondary Outcome
Title Clinical Benefit Rate is the Proportion of Patients With Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Hide Description Clinical benefit rate is the proportion of patients with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Time Frame Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
1-fostamatinib 200mg, BID, Oral
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Participants
5
3.Secondary Outcome
Title Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR).
Hide Description Overall response rate (ORR) is the proportion of patients with a best response of Complete Response (CR) or Partial Response (PR).
Time Frame Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
1-fostamatinib 200mg, BID, Oral
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Participants
0
4.Secondary Outcome
Title Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug.
Hide Description Duration of Overall Response is the time from first documentation of Complete or Partial Response (Cheson 2007), whichever occurs earlier, to discontinuation of study drug.
Time Frame Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
1-fostamatinib 200mg, BID, Oral
Overall Number of Participants Analyzed 18
Median (Standard Deviation)
Unit of Measure: Days
NA [1]   (NA)
[1]
Duration of response could not be calculated since 0 patients responded.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study
Hide Arm/Group Description 1-fostamatinib 200mg, BID, Oral
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Overall Study
Affected / at Risk (%)
Total   11/18 (61.11%) 
Blood and lymphatic system disorders   
Febrile Neutropenia † 1  1/18 (5.56%) 
Gastrointestinal disorders   
Dysphagia † 1  1/18 (5.56%) 
Melaena † 1  1/18 (5.56%) 
Vomiting † 1  2/18 (11.11%) 
General disorders   
Pyrexia † 1  1/18 (5.56%) 
Hepatobiliary disorders   
Hepatic Failure † 1  1/18 (5.56%) 
Infections and infestations   
Lobar Pneumonia † 1  1/18 (5.56%) 
Pneumonia † 1  1/18 (5.56%) 
Sepsis † 1  2/18 (11.11%) 
Skin Infection † 1  1/18 (5.56%) 
Injury, poisoning and procedural complications   
Wound Secretion † 1  1/18 (5.56%) 
Metabolism and nutrition disorders   
Anorexia † 1  1/18 (5.56%) 
Hypercalcaemia † 1  1/18 (5.56%) 
Hyponatraemia † 1  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea † 1  2/18 (11.11%) 
Pleural Effusion † 1  1/18 (5.56%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Study
Affected / at Risk (%)
Total   18/18 (100.00%) 
Blood and lymphatic system disorders   
Anaemia † 1  3/18 (16.67%) 
Febrile Neutropenia * 1  2/18 (11.11%) 
Neutropenia † 1  7/18 (38.89%) 
Pancytopenia * 1  1/18 (5.56%) 
Thrombocytopenia † 1  7/18 (38.89%) 
Cardiac disorders   
Tachycardia * 1  3/18 (16.67%) 
Endocrine disorders   
Inappropriate Antidiuretic Hormone Secretion † 1  1/18 (5.56%) 
Eye disorders   
Eye Irritation * 1  1/18 (5.56%) 
Eye Pain † 1  1/18 (5.56%) 
Lacrimation Increased * 1  2/18 (11.11%) 
Vision Blurred † 1  2/18 (11.11%) 
Gastrointestinal disorders   
Abdominal Distension * 1  2/18 (11.11%) 
Abdominal Pain † 1  1/18 (5.56%) 
Constipation * 1  3/18 (16.67%) 
Defaecation Urgency † 1  1/18 (5.56%) 
Diarrhoea * 1  7/18 (38.89%) 
Dry Mouth † 1  1/18 (5.56%) 
Dysphagia * 1  1/18 (5.56%) 
Flatulence † 1  1/18 (5.56%) 
Gastrooesophageal Reflux Disease * 1  1/18 (5.56%) 
Gingival Bleeding † 1  2/18 (11.11%) 
Nausea * 1  7/18 (38.89%) 
Oral Mucosal Blistering † 1  1/18 (5.56%) 
Oral Pain * 1  1/18 (5.56%) 
Rectal Haemorrhage † 1  1/18 (5.56%) 
Stomatitis * 1  2/18 (11.11%) 
Tongue Ulceration † 1  1/18 (5.56%) 
Vomiting * 1  7/18 (38.89%) 
General disorders   
Asthenia † 1  1/18 (5.56%) 
Chest Pain * 1  1/18 (5.56%) 
Chills † 1  7/18 (38.89%) 
Face Oedema * 1  3/18 (16.67%) 
Fatigue † 1  11/18 (61.11%) 
Localised Oedema * 1  1/18 (5.56%) 
Mucosal Inflammation † 1  2/18 (11.11%) 
Oedema * 1  1/18 (5.56%) 
Oedema Peripheral † 1  4/18 (22.22%) 
Pain * 1  1/18 (5.56%) 
Pyrexia † 1  8/18 (44.44%) 
Hepatobiliary disorders   
Hyperbilirubinaemia * 1  2/18 (11.11%) 
Infections and infestations   
Candidiasis † 1  1/18 (5.56%) 
Central Line Infection * 1  1/18 (5.56%) 
Cystitis † 1  1/18 (5.56%) 
Fungal Infection * 1  1/18 (5.56%) 
Fungal Skin Infection † 1  1/18 (5.56%) 
Gastroenteritis * 1  1/18 (5.56%) 
Nail Infection † 1  1/18 (5.56%) 
Sinusitis * 1  2/18 (11.11%) 
Skin Infection † 1  1/18 (5.56%) 
Upper Respiratory Tract Infection * 1  2/18 (11.11%) 
Urinary Tract Infection † 1  2/18 (11.11%) 
Urinary Tract Infection Bacterial * 1  1/18 (5.56%) 
Wound Infection † 1  1/18 (5.56%) 
Injury, poisoning and procedural complications   
Wound Secretion * 1  1/18 (5.56%) 
Alanine Aminotransferase Increased † 1  1/18 (5.56%) 
Aspartate Aminotransferase Increased * 1  6/18 (33.33%) 
Blood Albumin Decreased † 1  1/18 (5.56%) 
Blood Alkaline Phosphatase Increased * 1  2/18 (11.11%) 
Blood Bicarbonate Decreased † 1  1/18 (5.56%) 
Blood Bilirubin Increased * 1  1/18 (5.56%) 
Blood Creatine Increased † 1  1/18 (5.56%) 
Blood Glucose Increased * 1  1/18 (5.56%) 
Blood Lactate Dehydrogenase Increased † 1  1/18 (5.56%) 
Blood Magnesium Decreased * 1  1/18 (5.56%) 
Blood Phosphorus Decreased † 1  1/18 (5.56%) 
Blood Potassium Decreased * 1  1/18 (5.56%) 
Blood Potassium Increased † 1  1/18 (5.56%) 
Blood Sodium Decreased * 1  1/18 (5.56%) 
Blood Sodium Increased † 1  1/18 (5.56%) 
Haemoglobin Decreased * 1  4/18 (22.22%) 
Platelet Count Decreased † 1  1/18 (5.56%) 
Urine Output Decreased * 1  1/18 (5.56%) 
Weight Decreased † 1  1/18 (5.56%) 
White Blood Cell Count Decreased * 1  2/18 (11.11%) 
White Blood Cell Count Decreased † 1  5/18 (27.78%) 
Metabolism and nutrition disorders   
Decreased Appetite * 1  1/18 (5.56%) 
Dehydration † 1  2/18 (11.11%) 
Hypercalcaemia * 1  1/18 (5.56%) 
Hyperglycaemia † 1  1/18 (5.56%) 
Hypoalbuminaemia * 1  1/18 (5.56%) 
Hypokalaemia † 1  1/18 (5.56%) 
Hypomagnesaemia * 1  1/18 (5.56%) 
Hyponatraemia † 1  4/18 (22.22%) 
Hypophosphataemia * 1  1/18 (5.56%) 
Hypovolaemia † 1  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/18 (5.56%) 
Back Pain † 1  2/18 (11.11%) 
Bone Pain * 1  1/18 (5.56%) 
Buttock Pain † 1  1/18 (5.56%) 
Muscular Weakness * 1  1/18 (5.56%) 
Musculoskeletal Chest Pain † 1  1/18 (5.56%) 
Neck Pain * 1  1/18 (5.56%) 
Pain In Extremity † 1  2/18 (11.11%) 
Shoulder Pain * 1  2/18 (11.11%) 
Nervous system disorders   
Dizziness † 1  5/18 (27.78%) 
Dysgeusia * 1  2/18 (11.11%) 
Headache † 1  5/18 (27.78%) 
Memory Impairment * 1  1/18 (5.56%) 
Neuropathy Peripheral † 1  1/18 (5.56%) 
Parosmia * 1  1/18 (5.56%) 
Peripheral Sensory Neuropathy † 1  2/18 (11.11%) 
Poor Quality Sleep * 1  1/18 (5.56%) 
Sinus Headache † 1  1/18 (5.56%) 
Psychiatric disorders   
Depression * 1  1/18 (5.56%) 
Hallucination † 1  1/18 (5.56%) 
Renal and urinary disorders   
Dysuria * 1  1/18 (5.56%) 
Pollakiuria † 1  1/18 (5.56%) 
Renal Failure Acute * 1  1/18 (5.56%) 
Reproductive system and breast disorders   
Oedema Genital † 1  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Apnoea * 1  1/18 (5.56%) 
Cough † 1  5/18 (27.78%) 
Dyspnoea * 1  1/18 (5.56%) 
Dyspnoea Exertional † 1  1/18 (5.56%) 
Epistaxis * 1  3/18 (16.67%) 
Hypoxia † 1  2/18 (11.11%) 
Nasal Congestion * 1  1/18 (5.56%) 
Nasal Dryness † 1  1/18 (5.56%) 
Pharyngolaryngeal Pain * 1  2/18 (11.11%) 
Pleural Effusion † 1  1/18 (5.56%) 
Upper Respiratory Tract Congestion * 1  1/18 (5.56%) 
Skin and subcutaneous tissue disorders   
Ecchymosis † 1  1/18 (5.56%) 
Erythema * 1  1/18 (5.56%) 
Hyperhidrosis † 1  3/18 (16.67%) 
Night Sweats * 1  2/18 (11.11%) 
Pain Of Skin † 1  1/18 (5.56%) 
Periorbital Oedema * 1  2/18 (11.11%) 
Rash † 1  1/18 (5.56%) 
Rash Erythematous * 1  1/18 (5.56%) 
Skin Disorder † 1  1/18 (5.56%) 
Urticaria * 1  1/18 (5.56%) 
Vascular disorders   
Haematoma † 1  1/18 (5.56%) 
Hot Flush * 1  1/18 (5.56%) 
Hypertension † 1  4/18 (22.22%) 
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
This is a small, non-randomized study.
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.
An Investigator agrees to provide a copy of the publication to AstraZeneca for review at least 30 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AstraZeneca authorized MC publication or a period up to 18 months from study completi
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne-Marie Duliege, MD
Organization: Rigel
Phone: 650-624-1100
EMail: clinicaltrials@rigel.com
Layout table for additonal information
Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00798096    
Other Study ID Numbers: D4300C00024
C-935788-017 ( Other Identifier: Rigel Pharmaceuticals )
First Submitted: November 21, 2008
First Posted: November 25, 2008
Results First Submitted: May 14, 2014
Results First Posted: June 12, 2014
Last Update Posted: September 19, 2016