Trial Outcomes & Findings for Intra-patient Dose Escalation Study to Investigate Safety and Feasibility of Vactosertib in Treating Anemic MPN Patients (NCT NCT04103645)
NCT ID: NCT04103645
Last Updated: 2025-07-02
Results Overview
The safest minimally effective dose is defined as the lowest dose level for which no dose limiting toxicity (DLT) was observed in Tier 1 AND the lowest dose level for which at least one of the 12 subjects enrolled on Tier 1 meet Criteria for Clinical Benefit
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Baseline to week 16
Results posted on
2025-07-02
Participant Flow
Participant milestones
| Measure |
Vacosertib 50 mg BID
Vactosertib intra-patient dose finding cohort.
Vactosertib: 50 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Vacosertib 100 mg BID
Vactosertib: 100 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Vacosertib 150 mg BID
Vactosertib: 150 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Vacosertib 200mg BID
Vactosertib: 200 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 2: Vactosertib
This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|---|---|---|---|
|
Vactosertib 50 mg BID (Tier 1)
STARTED
|
2
|
0
|
0
|
0
|
0
|
|
Vactosertib 50 mg BID (Tier 1)
COMPLETED
|
2
|
0
|
0
|
0
|
0
|
|
Vactosertib 50 mg BID (Tier 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Vactosertib 100 mg BID (Tier 1)
STARTED
|
0
|
2
|
0
|
0
|
0
|
|
Vactosertib 100 mg BID (Tier 1)
COMPLETED
|
0
|
2
|
0
|
0
|
0
|
|
Vactosertib 100 mg BID (Tier 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Vactosertib 150 mg BID (Tier 1)
STARTED
|
0
|
0
|
2
|
0
|
0
|
|
Vactosertib 150 mg BID (Tier 1)
COMPLETED
|
0
|
0
|
2
|
0
|
0
|
|
Vactosertib 150 mg BID (Tier 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Vactosertib 200 mg BID (Tier 1)
STARTED
|
0
|
0
|
0
|
2
|
0
|
|
Vactosertib 200 mg BID (Tier 1)
COMPLETED
|
0
|
0
|
0
|
2
|
0
|
|
Vactosertib 200 mg BID (Tier 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Vactosertib (Tier 2)
STARTED
|
0
|
0
|
0
|
0
|
0
|
|
Vactosertib (Tier 2)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Vactosertib (Tier 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intra-patient Dose Escalation Study to Investigate Safety and Feasibility of Vactosertib in Treating Anemic MPN Patients
Baseline characteristics by cohort
| Measure |
All Participants
n=2 Participants
Vactosertib intra-patient dose finding cohort.
Vactosertib This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 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
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 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
|
PRIMARY outcome
Timeframe: Baseline to week 16The safest minimally effective dose is defined as the lowest dose level for which no dose limiting toxicity (DLT) was observed in Tier 1 AND the lowest dose level for which at least one of the 12 subjects enrolled on Tier 1 meet Criteria for Clinical Benefit
Outcome measures
| Measure |
All Participants
n=2 Participants
Vactosertib intra-patient dose finding cohort.
Vactosertib This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 100 mg BID
Vactosertib: 100 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 150 mg BID
Vactosertib: 150 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 200mg BID
Vactosertib: 200 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 2: Vactosertib
This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|---|---|---|---|
|
Identify the Safest, Minimally Effective Starting Dose Level for Patients on Tier 1
|
50 mg
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to week 12Identify the incidence of dose limiting toxicity (DLT) within the first 12 weeks which are defined as: 1. Any non-hematologic grade ≥3 toxicity except for nausea, vomiting or diarrhea lasting 3 days or less 2. Any grade 4 neutropenia of any duration 3. Any grade ≥3 neutropenia that has not recovered to grade ≥2 within 7 days of onset 4. Any grade ≥3 febrile neutropenia 5. Any grade ≥3 thrombocytopenia associated with clinically significant bleeding or requiring platelet transfusion
Outcome measures
| Measure |
All Participants
n=2 Participants
Vactosertib intra-patient dose finding cohort.
Vactosertib This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 100 mg BID
n=2 Participants
Vactosertib: 100 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 150 mg BID
n=2 Participants
Vactosertib: 150 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 200mg BID
n=2 Participants
Vactosertib: 200 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 2: Vactosertib
This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|---|---|---|---|
|
Identify Dose Limiting Toxicities (DLTs) in Patients With MPN Enrolled on Tier 1
|
0 Count of DLTs
|
0 Count of DLTs
|
0 Count of DLTs
|
0 Count of DLTs
|
—
|
PRIMARY outcome
Timeframe: Baseline to week 12Identify the Maximum Tolerated Dose (MTD) of vactosertib defined as the highest dose which does not meet the Tier 1 stopping rule. The tier 1 stopping rule is triggered if any patient experiences a Grade 5 dose limiting toxicity within the first 12 weeks of starting vactosertib or if more than five patients experience a dose limiting toxicity at any dose within the first 12 weeks on study.
Outcome measures
| Measure |
All Participants
n=2 Participants
Vactosertib intra-patient dose finding cohort.
Vactosertib This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 100 mg BID
Vactosertib: 100 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 150 mg BID
Vactosertib: 150 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 200mg BID
Vactosertib: 200 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 2: Vactosertib
This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|---|---|---|---|
|
Identify the Maximum Tolerated Dose (MTD) of Vactosertib in Patients With MPN Enrolled on Tier 1
|
200 mg
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline to week 16Population: No subjects went on to the Tier 2 portion of the study
Number of patients who achieve an erythropoietic response defined by: 1. HGB increase of 1.5g/dL compared to baseline hemoglobin; 2. Reduction in PRBC transfusion rate to ≤ 50% of pre-treatment transfusion rate; or 3. Reduction in PRBC transfusions by ≥ 4 Units over an 8-week period.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline to week 16Population: No subjects went on to the Tier 2 portion of the study
Number of patients who have achieved clinical response defined by a reduction in Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) total score by ≥ 50% compared to pretreatment score
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline to week 16Population: No subjects went on to the Tier 2 portion of the study
Number of patients who have achieved splenic response defined by: 1. Non-palpable spleen when baseline spleen size was 5-10 cm below left costal margin; 2. At least 50% reduction in spleen size when baseline spleen is \> 10 cm below left costal margin 3. At least 35% reduction in spleen size as assessed by US, CT or MRI.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline to week 12Population: No subjects went on to the Tier 2 portion of the study
Identify the number of dose limiting toxicities (DLT) within the first 12 weeks which are defined as: 1. Any non-hematologic grade ≥3 toxicity except for nausea, vomiting or diarrhea lasting 3 days or less 2. Any grade 4 neutropenia of any duration 3. Any grade ≥3 neutropenia that has not recovered to grade ≥2 within 7 days of onset 4. Any grade ≥3 febrile neutropenia 5. Any grade ≥3 thrombocytopenia associated with clinically significant bleeding or requiring platelet transfusion
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline to week 12Population: No subjects went on to the Tier 2 portion of the study
Identify the Maximum Tolerated Dose (MTD) of vactosertib defined as the highest dose which does not meet the Tier 2 stopping rule. The tier 2 stopping rule is triggered if any patient experiences a Grade 5 dose limiting toxicity within the first 12 weeks of starting vactosertib or if more than five patients experience a dose limiting toxicity at any dose within the first 12 weeks on study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 weeksPopulation: 0 subjects were analyzed for Tier 1 subjects taking 50mg, 100mg, and 150mg of Vactosertib because no participants were taking those doses at 16 weeks. 0 subjects were analyzed in Tier 2 because no subjects were in Tier 2 at 16 weeks.
Histological response is defined by reduction of any amount in grade of bone marrow fibrosis by histopathologic assessment at 16 weeks.
Outcome measures
| Measure |
All Participants
Vactosertib intra-patient dose finding cohort.
Vactosertib This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 100 mg BID
Vactosertib: 100 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 150 mg BID
Vactosertib: 150 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 200mg BID
n=2 Participants
Vactosertib: 200 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 2: Vactosertib
This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|---|---|---|---|
|
Number of Patients in Which a Histological Response is Seen
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: 0 subjects were analyzed for Tier 1 subjects taking 50mg, 100mg, and 150mg of Vactosertib because no participants were taking those doses at 16 weeks. 0 subjects were analyzed in Tier 2 because no subjects were in Tier 2 at 16 weeks.
Number of patients in which a molecular response is seen. Molecular response is defined by a decrease in VAF of MPN-driver mutations (eg. JAK2, CALR, and MPL allelic ratio) in blood and/or bone marrow cells
Outcome measures
| Measure |
All Participants
Vactosertib intra-patient dose finding cohort.
Vactosertib This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 100 mg BID
Vactosertib: 100 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 150 mg BID
Vactosertib: 150 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 200mg BID
n=2 Participants
Vactosertib: 200 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 2: Vactosertib
This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|---|---|---|---|
|
Number of Patients in Which a Molecular Response is Seen
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: 0 subjects were analyzed for Tier 1 subjects taking 50mg, 100mg, and 150mg of Vactosertib because no participants were taking those doses at 16 weeks. 0 subjects were analyzed in Tier 2 because no subjects were in Tier 2 at 16 weeks.
A pharmacodynamic response is defined as any of the following: 1. Reduced immunohistochemical staining for SMAD2/3 phosphorylation in bone marrow biopsy sections. 2. Reduced mean fluorescence intensity of SMAD2/3 phosphorylation staining in peripheral blood hematopoietic stem and progenitor cells (HSPCs) or mature progeny as assessed by flow cytometry. 3. Reduced mean fluorescence intensity of SMAD2/3 phosphorylation staining in bone marrow hematopoietic stem and progenitor cells (HSPCs) or mature progeny as assessed by flow cytometry.
Outcome measures
| Measure |
All Participants
Vactosertib intra-patient dose finding cohort.
Vactosertib This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 100 mg BID
Vactosertib: 100 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 150 mg BID
Vactosertib: 150 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 200mg BID
n=2 Participants
Vactosertib: 200 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 2: Vactosertib
This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|---|---|---|---|
|
Number of Patients in Which a Pharmacodynamic Response is Seen
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline to 16 weeksPopulation: No subjects enrolled on Tier 2
Outcome measures
| Measure |
All Participants
n=2 Participants
Vactosertib intra-patient dose finding cohort.
Vactosertib This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 100 mg BID
n=2 Participants
Vactosertib: 100 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 150 mg BID
n=2 Participants
Vactosertib: 150 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 200mg BID
n=2 Participants
Vactosertib: 200 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 2: Vactosertib
This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|---|---|---|---|
|
Number of Patients Who Have Experienced Any of the Following: Hematologic Toxicities, Infections, Disease Progression, and Thrombosis Events
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 1 Day 1 to 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks.The overall survival range describes the average length of time subjects were followed for survival
Outcome measures
| Measure |
All Participants
n=2 Participants
Vactosertib intra-patient dose finding cohort.
Vactosertib This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 100 mg BID
Vactosertib: 100 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 150 mg BID
Vactosertib: 150 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 200mg BID
Vactosertib: 200 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 2: Vactosertib
This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|---|---|---|---|
|
Overall Survival Defined as the Amount of Time a Patient is Alive After Starting Study Treatment
|
54 Weeks
Interval 54.0 to 54.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1 to 6 months post treatment discontinuationOutcome measures
| Measure |
All Participants
n=2 Participants
Vactosertib intra-patient dose finding cohort.
Vactosertib This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 100 mg BID
Vactosertib: 100 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 150 mg BID
Vactosertib: 150 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 200mg BID
Vactosertib: 200 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 2: Vactosertib
This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|---|---|---|---|
|
Progression Free Survival Defined as the Duration of Time From Start of Treatment to Time of Progression
|
25.5 Weeks
Interval 21.0 to 30.0
|
—
|
—
|
—
|
—
|
Adverse Events
Tier 1: Vactosertib 50 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Tier 1: Vactosertib 100 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Tier 1: Vactosertib 150 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Tier 1: Vactosertib 200mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Tier 2: Vactosertib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Participants
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tier 1: Vactosertib 50 mg BID
n=2 participants at risk
Vactosertib intra-patient dose finding cohort.
Vactosertib: 50 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 100 mg BID
n=2 participants at risk
Vactosertib: 100 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 150 mg BID
n=2 participants at risk
Vactosertib: 150 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 1: Vactosertib 200mg BID
n=2 participants at risk
Vactosertib: 200 mg BID This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
Tier 2: Vactosertib
This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
All Participants
n=2 participants at risk
Vactosertib intra-patient dose finding cohort. Vactosertib This drug is a TG-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased Appetite
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
General disorders
Fatigue
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
100.0%
2/2 • Number of events 2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
100.0%
2/2 • Number of events 2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Musculoskeletal and connective tissue disorders
Pain extremity (left lower leg)
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
General disorders
Drowsiness
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
|
Infections and infestations
Skin Infection
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
0.00%
0/2 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
—
0/0 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
50.0%
1/2 • Number of events 1 • Deaths were collected from Week 1 Day 1 through 6 months post treatment discontinuation. This collection period for both subjects on study was over an average duration of 54 weeks. Serious and Other (Not Including Serious) Adverse Events were collected while subjects were on treatment. This collection period for both subjects on study was over an average duration of 28 weeks.
All subjects treated with Vactosertib
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place