Trial Outcomes & Findings for A Phase 1-2 Study of CF102 in Patients With Advanced Hepatocellular Carcinoma (NCT NCT00790218)
NCT ID: NCT00790218
Last Updated: 2022-05-17
Results Overview
Dose-limiting toxicity was defined as a clinically significant AE or laboratory abnormality occurring in Cycle 1
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
From start of treatment until Day 28 of Cycle 1
Results posted on
2022-05-17
Participant Flow
Participant milestones
| Measure |
CF102 1mg
CF102: CF102 tablets were given orally twice daily
|
CF102 5mg
CF102: CF102 tablets were given orally twice daily
|
CF102 25mg
CF102: CF102 tablets were given orally twice daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
7
|
|
Overall Study
COMPLETED
|
5
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
CF102 1mg
CF102: CF102 tablets were given orally twice daily
|
CF102 5mg
CF102: CF102 tablets were given orally twice daily
|
CF102 25mg
CF102: CF102 tablets were given orally twice daily
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 1-2 Study of CF102 in Patients With Advanced Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
CF102
n=19 Participants
CF102: CF102 capsules twice daily by mouth
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until Day 28 of Cycle 1Population: Safety Population (all subjects receiving at least one dose of study drug)
Dose-limiting toxicity was defined as a clinically significant AE or laboratory abnormality occurring in Cycle 1
Outcome measures
| Measure |
CF102 1mg
n=6 Participants
CF102 tablets given orally, BID
|
CF102 5mg
n=6 Participants
CF102 tablets given orally, BID
|
CF102 25mg
n=7 Participants
CF102 tablets given orally, BID
|
|---|---|---|---|
|
Dose Limiting Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: first 28 days (Cycle 1)Population: All subjects were evaluated for DLTs in the first cycle of therapy.
The MTD was defined as the highest dose level at which \< 2 of 6 patients developed Cycle 1 DLT.
Outcome measures
| Measure |
CF102 1mg
n=6 Participants
CF102 tablets given orally, BID
|
CF102 5mg
n=6 Participants
CF102 tablets given orally, BID
|
CF102 25mg
n=5 Participants
CF102 tablets given orally, BID
|
|---|---|---|---|
|
Maximum Tolerated Dose
|
NA milligrams
No subjects in any cohort experienced dose-limiting toxicity, therefore analysis of maximum tolerated dose was not possible.
|
NA milligrams
No subjects in any cohort experienced dose-limiting toxicity, therefore analysis of maximum tolerated dose was not possible.
|
NA milligrams
No subjects in any cohort experienced dose-limiting toxicity, therefore analysis of maximum tolerated dose was not possible.
|
PRIMARY outcome
Timeframe: Dose Escalation Phase on Day 1 and Day 29 pre-dose and at 1, 2, 3, 4, 6, 8 hours post-dosePopulation: The first 3 subjects in each dosing cohort participated in the pharmacokinetic sampling.
Blood samples were collected and plasma concentrations determined using a high-pressure liquid chromatography method.
Outcome measures
| Measure |
CF102 1mg
n=3 Participants
CF102 tablets given orally, BID
|
CF102 5mg
n=3 Participants
CF102 tablets given orally, BID
|
CF102 25mg
n=3 Participants
CF102 tablets given orally, BID
|
|---|---|---|---|
|
Maximum Plasma Concentration of CF102 (Cmax)
Day 1
|
4.455 ng/mL
Standard Deviation 2.975
|
25.10 ng/mL
Standard Deviation 16.93
|
98.36 ng/mL
Standard Deviation 22.60
|
|
Maximum Plasma Concentration of CF102 (Cmax)
Day 29
|
10.46 ng/mL
Standard Deviation 8.864
|
53.69 ng/mL
Standard Deviation 31.76
|
330.6 ng/mL
Standard Deviation 61.17
|
SECONDARY outcome
Timeframe: 6 monthsTherapeutic effect of CF102 in hepatocellular carcinoma measured by number of subjects with objective tumor response
Outcome measures
| Measure |
CF102 1mg
n=6 Participants
CF102 tablets given orally, BID
|
CF102 5mg
n=6 Participants
CF102 tablets given orally, BID
|
CF102 25mg
n=5 Participants
CF102 tablets given orally, BID
|
|---|---|---|---|
|
Number of Subjects With Objective Tumor Response
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: No data was collected for this exploratory endpoint.
The Peripheral Blood Mononuclear Cells (PBMC) were to be collected at Baseline and Day 28 in order to evaluate the Adenosine A3 receptor (A3AR) and PBMC biomarkers, and clinical effects of CF102.
Outcome measures
Outcome data not reported
Adverse Events
CF102 1mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
CF102 5mg
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
CF102 25mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CF102 1mg
n=6 participants at risk
CF102: CF102 capsules twice daily by mouth
|
CF102 5mg
n=6 participants at risk
CF102: CF102 capsules twice daily by mouth
|
CF102 25mg
n=7 participants at risk
CF102: CF102 capsules twice daily by mouth
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Inflammation - knee
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Hospitalization due to ascites paracentesis
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
33.3%
2/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
General disorders
Fatigue
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Infections and infestations
UTI
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Vascular disorders
Thrombus - left leg
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Injury, poisoning and procedural complications
Pathological fracture sacrum
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
Other adverse events
| Measure |
CF102 1mg
n=6 participants at risk
CF102: CF102 capsules twice daily by mouth
|
CF102 5mg
n=6 participants at risk
CF102: CF102 capsules twice daily by mouth
|
CF102 25mg
n=7 participants at risk
CF102: CF102 capsules twice daily by mouth
|
|---|---|---|---|
|
General disorders
Fatigue
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
33.3%
2/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
28.6%
2/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
General disorders
Asthenia
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
33.3%
2/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
28.6%
2/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
28.6%
2/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
28.6%
2/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
General disorders
Chest pain
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Reproductive system and breast disorders
Nipple pain
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
General disorders
Oedema
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Pelvic pain
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Blood and lymphatic system disorders
Petechiae
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Infections and infestations
Viral infection
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Immune system disorders
Hypersensitivity
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Nervous system disorders
Cerebrovascular accident
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Infections and infestations
Cellulitis
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
General disorders
General Physical Health Deterioration
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
33.3%
2/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
16.7%
1/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
|
Injury, poisoning and procedural complications
Pathological Fracture
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
0.00%
0/6 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
14.3%
1/7 • Over the course of the study to include. Up to 30 weeks (including up to 6 cycles of 28 days plus an approximately 30 day followup period).
|
Additional Information
Sari Fishman, Director of Clincal Trials
Can-Fite BioPharma
Phone: 972528998666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place