Trial Outcomes & Findings for A Broad Multi-histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-small Cell Lung, Head and Neck Hepatocellular and Renal Cell Carcinomas, and Pheochromocytoma and Thyroid Tumors (Multi-H... (NCT NCT00923481)
NCT ID: NCT00923481
Last Updated: 2015-09-30
Results Overview
Response is assessed by the RECIST (response criteria in solid tumors)criteria. A complete response (CR) is disappearance of all target lesions , partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
24 months
Results posted on
2015-09-30
Participant Flow
Participant milestones
| Measure |
Multi-kinase Inhibitor Fosamatinib Disodium
200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Broad Multi-histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-small Cell Lung, Head and Neck Hepatocellular and Renal Cell Carcinomas, and Pheochromocytoma and Thyroid Tumors (Multi-H...
Baseline characteristics by cohort
| Measure |
Multi-kinase Inhibitor Fosamatinib Disodium
n=37 Participants
200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
57.73 years
STANDARD_DEVIATION 9.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsResponse is assessed by the RECIST (response criteria in solid tumors)criteria. A complete response (CR) is disappearance of all target lesions , partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Multi-kinase Inhibitor Fosamatinib Disodium
n=37 Participants
200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
|
|---|---|
|
Response Rate
Complete response
|
0 Participants
|
|
Response Rate
Partial Response
|
0 Participants
|
|
Response Rate
Progressive disease
|
26 Participants
|
|
Response Rate
Stable disease
|
11 Participants
|
SECONDARY outcome
Timeframe: 23 monthsHere is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Multi-kinase Inhibitor Fosamatinib Disodium
n=37 Participants
200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
|
|---|---|
|
Number of Participants With Adverse Events
|
37 Participants
|
Adverse Events
Multi-kinase Inhibitor Fosamatinib Disodium
Serious events: 11 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Multi-kinase Inhibitor Fosamatinib Disodium
n=37 participants at risk
200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
|
|---|---|
|
Investigations
Alkaline phosphatase
|
2.7%
1/37 • Number of events 1
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
2.7%
1/37 • Number of events 1
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Colitis, infectious (e.g., Clostridium difficile)
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term::Death NOS
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Death not associated with CTCAE term: Death Progression NOS
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway
|
2.7%
1/37 • Number of events 1
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
2.7%
1/37 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.7%
1/37 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
2.7%
1/37 • Number of events 1
|
Other adverse events
| Measure |
Multi-kinase Inhibitor Fosamatinib Disodium
n=37 participants at risk
200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
|
|---|---|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
27.0%
10/37 • Number of events 16
|
|
Investigations
Platelets
|
16.2%
6/37 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
16.2%
6/37 • Number of events 8
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
59.5%
22/37 • Number of events 57
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
62.2%
23/37 • Number of events 66
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
78.4%
29/37 • Number of events 77
|
|
Investigations
Alkaline phosphatase
|
45.9%
17/37 • Number of events 32
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
Bicarbonate, serum low
|
5.4%
2/37 • Number of events 2
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
35.1%
13/37 • Number of events 29
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
2.7%
1/37 • Number of events 1
|
|
Injury, poisoning and procedural complications
Burn
|
2.7%
1/37 • Number of events 1
|
|
Investigations
CPK (creatine phosphokinase)
|
18.9%
7/37 • Number of events 15
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
27.0%
10/37 • Number of events 19
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
13.5%
5/37 • Number of events 7
|
|
Investigations
Cholesterol, serum-high (hypercholesteremia)
|
5.4%
2/37 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.2%
6/37 • Number of events 7
|
|
Investigations
Creatinine
|
10.8%
4/37 • Number of events 8
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
2/37 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, laceration)
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
16.2%
6/37 • Number of events 11
|
|
Nervous system disorders
Dizziness
|
10.8%
4/37 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.8%
4/37 • Number of events 6
|
|
General disorders
Edema::head and neck
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Edema limb
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Extremity-lower (gait/walking)
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
32.4%
12/37 • Number of events 12
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
8.1%
3/37 • Number of events 4
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hyperglycemia)
|
2.7%
1/37 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
2.7%
1/37 • Number of events 1
|
|
Investigations
Hemoglobin
|
64.9%
24/37 • Number of events 47
|
|
Renal and urinary disorders
Hemoglobinuria
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Respiratory tract NOS
|
2.7%
1/37 • Number of events 1
|
|
Vascular disorders
Hypertension
|
29.7%
11/37 • Number of events 19
|
|
Vascular disorders
Hypotension
|
5.4%
2/37 • Number of events 2
|
|
Renal and urinary disorders
Hypoxia
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Eye NOS
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Neck NOS
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
8.1%
3/37 • Number of events 3
|
|
Infections and infestations
Infection with unknown ANC::Sinus
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC::Upper airway NOS
|
2.7%
1/37 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
5.4%
2/37 • Number of events 2
|
|
Investigations
Leukocytes (total WBC)
|
40.5%
15/37 • Number of events 37
|
|
Investigations
Lymphopenia
|
67.6%
25/37 • Number of events 62
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
43.2%
16/37 • Number of events 29
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
13.5%
5/37 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
18.9%
7/37 • Number of events 8
|
|
Nervous system disorders
Neuropathy - motor
|
2.7%
1/37 • Number of events 1
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
10.8%
4/37 • Number of events 6
|
|
General disorders
Pain::Other (Specify, pain-epigastric)
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Paib:: Abdomen NOS
|
10.8%
4/37 • Number of events 5
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
2.7%
1/37 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
2.7%
1/37 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain::Chest wall
|
5.4%
2/37 • Number of events 3
|
|
Eye disorders
Pain::Eye
|
2.7%
1/37 • Number of events 2
|
|
Nervous system disorders
Pain::Head/headache
|
10.8%
4/37 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
2.7%
1/37 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
8.1%
3/37 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain::Neck
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Throat/pharynx/larynx
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
16.2%
6/37 • Number of events 6
|
|
Renal and urinary disorders
Proteinuria
|
2.7%
1/37 • Number of events 2
|
|
General disorders
Rigors/chills
|
10.8%
4/37 • Number of events 5
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
54.1%
20/37 • Number of events 33
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
2.7%
1/37 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
2.7%
1/37 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
8.1%
3/37 • Number of events 5
|
|
Eye disorders
Vision-blurred vision
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
2/37 • Number of events 3
|
|
Investigations
Weight loss
|
5.4%
2/37 • Number of events 2
|
Additional Information
Dr. Shivaani Kummar
National Cancer Institute, National Institutes of Health
Phone: 301-435-5402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place