Trial Outcomes & Findings for Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma (NCT NCT00798096)
NCT ID: NCT00798096
Last Updated: 2016-09-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
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)
Results posted on
2016-09-19
Participant Flow
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.
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
Participant milestones
| Measure |
Overall Study
1-fostamatinib 200mg, BID, Oral
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Overall Study
1-fostamatinib 200mg, BID, Oral
|
|---|---|
|
Overall Study
Ongoing
|
2
|
Baseline Characteristics
Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Overall Study
n=18 Participants
1-fostamatinib 200mg, BID, Oral
|
|---|---|
|
Age, Continuous
|
68.5 Years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other - Unknown
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)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.
Outcome measures
| Measure |
Overall Study
n=18 Participants
1-fostamatinib 200mg, BID, Oral
|
|---|---|
|
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).
|
4 Participants
|
SECONDARY outcome
Timeframe: 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)Clinical benefit rate is the proportion of patients with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Outcome measures
| Measure |
Overall Study
n=18 Participants
1-fostamatinib 200mg, BID, Oral
|
|---|---|
|
Clinical Benefit Rate is the Proportion of Patients With Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
|
5 Participants
|
SECONDARY outcome
Timeframe: 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)Overall response rate (ORR) is the proportion of patients with a best response of Complete Response (CR) or Partial Response (PR).
Outcome measures
| Measure |
Overall Study
n=18 Participants
1-fostamatinib 200mg, BID, Oral
|
|---|---|
|
Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR).
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)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.
Outcome measures
| Measure |
Overall Study
n=18 Participants
1-fostamatinib 200mg, BID, Oral
|
|---|---|
|
Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug.
|
NA Days
Standard Deviation NA
Duration of response could not be calculated since 0 patients responded.
|
Adverse Events
Overall Study
Serious events: 11 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall Study
n=18 participants at risk
1-fostamatinib 200mg, BID, Oral
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.6%
1/18
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18
|
|
Gastrointestinal disorders
Melaena
|
5.6%
1/18
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18
|
|
General disorders
Pyrexia
|
5.6%
1/18
|
|
Hepatobiliary disorders
Hepatic Failure
|
5.6%
1/18
|
|
Infections and infestations
Lobar Pneumonia
|
5.6%
1/18
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18
|
|
Infections and infestations
Sepsis
|
11.1%
2/18
|
|
Infections and infestations
Skin Infection
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
2/18
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.6%
1/18
|
Other adverse events
| Measure |
Overall Study
n=18 participants at risk
1-fostamatinib 200mg, BID, Oral
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
11.1%
2/18
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
11.1%
2/18
|
|
Nervous system disorders
Dizziness
|
27.8%
5/18
|
|
Nervous system disorders
Dysgeusia
|
11.1%
2/18
|
|
Nervous system disorders
Headache
|
27.8%
5/18
|
|
Nervous system disorders
Memory Impairment
|
5.6%
1/18
|
|
Nervous system disorders
Neuropathy Peripheral
|
5.6%
1/18
|
|
Nervous system disorders
Parosmia
|
5.6%
1/18
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
11.1%
2/18
|
|
Nervous system disorders
Poor Quality Sleep
|
5.6%
1/18
|
|
Nervous system disorders
Sinus Headache
|
5.6%
1/18
|
|
Psychiatric disorders
Depression
|
5.6%
1/18
|
|
Psychiatric disorders
Hallucination
|
5.6%
1/18
|
|
Renal and urinary disorders
Dysuria
|
5.6%
1/18
|
|
Renal and urinary disorders
Pollakiuria
|
5.6%
1/18
|
|
Renal and urinary disorders
Renal Failure Acute
|
5.6%
1/18
|
|
Reproductive system and breast disorders
Oedema Genital
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
5/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
3/18
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
2/18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
11.1%
2/18
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
3/18
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
11.1%
2/18
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Periorbital Oedema
|
11.1%
2/18
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.6%
1/18
|
|
Vascular disorders
Haematoma
|
5.6%
1/18
|
|
Vascular disorders
Hot Flush
|
5.6%
1/18
|
|
Vascular disorders
Hypertension
|
22.2%
4/18
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
3/18
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
11.1%
2/18
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.9%
7/18
|
|
Blood and lymphatic system disorders
Pancytopenia
|
5.6%
1/18
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
38.9%
7/18
|
|
Cardiac disorders
Tachycardia
|
16.7%
3/18
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
5.6%
1/18
|
|
Eye disorders
Eye Irritation
|
5.6%
1/18
|
|
Eye disorders
Eye Pain
|
5.6%
1/18
|
|
Eye disorders
Lacrimation Increased
|
11.1%
2/18
|
|
Eye disorders
Vision Blurred
|
11.1%
2/18
|
|
Gastrointestinal disorders
Abdominal Distension
|
11.1%
2/18
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
1/18
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18
|
|
Gastrointestinal disorders
Defaecation Urgency
|
5.6%
1/18
|
|
Gastrointestinal disorders
Diarrhoea
|
38.9%
7/18
|
|
Gastrointestinal disorders
Dry Mouth
|
5.6%
1/18
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.6%
1/18
|
|
Gastrointestinal disorders
Gingival Bleeding
|
11.1%
2/18
|
|
Gastrointestinal disorders
Nausea
|
38.9%
7/18
|
|
Gastrointestinal disorders
Oral Mucosal Blistering
|
5.6%
1/18
|
|
Gastrointestinal disorders
Oral Pain
|
5.6%
1/18
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
5.6%
1/18
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
2/18
|
|
Gastrointestinal disorders
Tongue Ulceration
|
5.6%
1/18
|
|
Gastrointestinal disorders
Vomiting
|
38.9%
7/18
|
|
General disorders
Asthenia
|
5.6%
1/18
|
|
General disorders
Chest Pain
|
5.6%
1/18
|
|
General disorders
Chills
|
38.9%
7/18
|
|
General disorders
Face Oedema
|
16.7%
3/18
|
|
General disorders
Fatigue
|
61.1%
11/18
|
|
General disorders
Localised Oedema
|
5.6%
1/18
|
|
General disorders
Mucosal Inflammation
|
11.1%
2/18
|
|
General disorders
Oedema
|
5.6%
1/18
|
|
General disorders
Oedema Peripheral
|
22.2%
4/18
|
|
General disorders
Pain
|
5.6%
1/18
|
|
General disorders
Pyrexia
|
44.4%
8/18
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
11.1%
2/18
|
|
Infections and infestations
Candidiasis
|
5.6%
1/18
|
|
Infections and infestations
Central Line Infection
|
5.6%
1/18
|
|
Infections and infestations
Cystitis
|
5.6%
1/18
|
|
Infections and infestations
Fungal Infection
|
5.6%
1/18
|
|
Infections and infestations
Fungal Skin Infection
|
5.6%
1/18
|
|
Infections and infestations
Gastroenteritis
|
5.6%
1/18
|
|
Infections and infestations
Nail Infection
|
5.6%
1/18
|
|
Infections and infestations
Sinusitis
|
11.1%
2/18
|
|
Infections and infestations
Skin Infection
|
5.6%
1/18
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
11.1%
2/18
|
|
Infections and infestations
Urinary Tract Infection
|
11.1%
2/18
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
5.6%
1/18
|
|
Infections and infestations
Wound Infection
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Alanine Aminotransferase Increased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Aspartate Aminotransferase Increased
|
33.3%
6/18
|
|
Injury, poisoning and procedural complications
Blood Albumin Decreased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Blood Alkaline Phosphatase Increased
|
11.1%
2/18
|
|
Injury, poisoning and procedural complications
Blood Bicarbonate Decreased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Blood Bilirubin Increased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Blood Creatine Increased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Blood Glucose Increased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Blood Lactate Dehydrogenase Increased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Blood Magnesium Decreased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Blood Phosphorus Decreased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Blood Potassium Decreased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Blood Potassium Increased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Blood Sodium Decreased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Blood Sodium Increased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Haemoglobin Decreased
|
22.2%
4/18
|
|
Injury, poisoning and procedural complications
Platelet Count Decreased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Urine Output Decreased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Weight Decreased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
White Blood Cell Count Decreased
|
27.8%
5/18
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
22.2%
4/18
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
2/18
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
5.6%
1/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER