Anemia, Bladder Cancer, Cancer of Head and Neck, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small-Cell Lung, Uterine Cervical Cancer
Conditions
Keywords
Chemotherapy induced anemia, Non-small cell lung cancer
Brief summary
The purpose of this study was to determine an effective and safe dose of sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia (CIA) in participants with metastatic non-small cell lung cancer (NSCLC) who are being treated with first-line platinum based chemotherapy.
Detailed description
The ACE-011-NSCL-001 Phase 2a study was an open-label, randomized, dose-ranging study designed to assess the efficacy, safety, tolerability, pharmacokinetic and quality of life of sotatercept for treatment of CIA in participants with advanced or metastatic solid tumors treated with platinum-based chemotherapeutic regimens. Other objectives included the effect of sotatercept treatment on bone metabolism, the evaluation of the expression of Activin A and other proteins/biomarkers (including myostatin and follistatin) and the assessment of renal function biomarkers. The study consisted of a Screening Period, a Treatment Period of approximately 6 months (up to 4 doses of sotatercept at either 15 mg or 30 mg administered subcutaneously every 42 days) and a Post-treatment Follow-up Period or End of Treatment (42 days after the last dose of sotatercept). The study was terminated early due to a slower than expected rate of enrollment as a result of substantial changes in the standard of care for cancer participants with anemia which resulted in challenges to timely accrual and completion of the study. Therefore, 26 participants were randomized into the study and the planned Part 2 of the study consisting of a double-blind, randomized, placebo-controlled Phase 2b/3 study conducted at the optimal dose of sotatercept in up to 750 participants with metastatic NSCLC was not performed. Due to the small sample size and variability of the data, changes were made to modify the study endpoints and revise them to be exploratory only.
Interventions
DRUGSotatercept 15 mg
Sotatercept 15 mg SC injection once every 42 days, up to four doses
DRUGSotatercept 30 mg
Sotatercept 30 mg SC injection once every 42 days, up to four doses
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women \>18 years of age 2. Part 1: Histologically confirmed (cytology or biopsy) solid tumor malignancy, excluding those solid tumors treated with curative intent. Part 2: Histologically confirmed non-small cell lung cancer 3. Documented metastatic disease 4. Measurable or non-measurable disease evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 5. All of the following laboratory values: * Hemoglobin ≥6.5 to \<11.0 g/dL (≥65 to \<110 g/L), due to chemotherapy-induced anemia * Absolute neutrophil count ≥500/mm\^3 * Platelet count ≥75,000/mm\^3 (\>2 hours since prior platelet transfusion * Adequate renal function * creatinine clearance ≥40mL/min or ≥50 mL/min if cisplatin is concomitantly administered and * urine protein / creatinine ratio ≤1.0; or ≤2.0 if bevacizumab (Avastin®) is concomitantly administered * Hepatic function (bilirubin \<1.5 x upper limits of normal (ULN); AST and ALT \<3.0 x ULN and ≤5.0 ULN for participants with liver metastases) 6. Participants must have received: * at least one cycle and up to 4 cycles (q3w schedule) of platinum-based chemotherapy and be randomized prior to receiving Cycle 5 OR * at least one cycle and up to 3 months (depending upon regimen) of platinum-based chemotherapy 7. \>28 days since previous treatment with ESA 8. \>14 days since last red blood cell transfusions 9. Eastern Oncology Cooperative Group (ECOG) Performance status 0-2 10. For females of childbearing potential, highly effective method of birth control for at least 28 days before starting study, during participation and at least 112 days following last dose of sotatercept 11. Males must use latex condom or non-latex condom not made of (animal) membrane during any sexual contact with female of childbearing potential 12. Life expectancy of \>3 months 13. Willing to adhere to study visit schedule 14. Understand and voluntarily sign informed consent
Exclusion criteria
Part 2 only, history of prior regimen(s)of platinum-based chemotherapy for metastatic NSCLC and/or history of adjuvant platinum-based chemotherapy with last dose received less than six months prior to the start of current first-line platinum-based chemotherapy for metastatic NSCLC. 1. National Cancer Institute Common Terminology for Adverse Events Grade \>3 toxicity 2. Prior radiation to \>20% of whole skeleton 3. Prior regimen(s) of platinum based chemotherapy for metastatic disease and/or history of adjuvant platinum-based chemotherapy with the last dose received less than six months prior to the start of current first-line platinum-based chemotherapy for metastatic disease 4. Central nervous system metastases 5. Clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic, or genitourinary disease unrelated to underlying malignancy 6. Classification of 3 or higher heart failure (as classified by New York Heart Association) 7. History of thrombosis, deep vein thrombosis, pulmonary emboli, or embolic stroke, if not stable on anticoagulants and/or one of these events occurring in past 6 months 8. Diagnosis of a myeloid malignancy or known history of myelodysplasia 9. Recent history (within 14 days of Day 1) of IV/oral antibiotics due to post septic episode 10. Uncontrolled hypertension. Controlled hypertension is considered clinically stable, and systolic blood pressure (SBP) must be \<150 mmHg and diastolic blood pressure (DBP) must be \< 00 mmHg. 11. Known human immunodeficiency virus (HIV) 12. Known active hepatitis B or C antibody 13. Iron deficiency 14. History of anemia as a result of inherited hemoglobinopathy 15. History of anemia due to autoimmune or hereditary hemolysis or gastrointestinal bleeding 16. Received treatment with another investigational drug or device within 28 days prior to Day 1, or if the half life of the previous product is known, within 5 times the half life prior to dosing, whichever may be longer. 17. Any prior use of sotatercept. 18. Pregnant or lactating females or females planning to become pregnant 19. History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product (Refer to the Investigator's Brochure for further information). 20. Major surgery within 30 days prior to Day 1 (participants must have completely recovered from any previous surgery prior to Day 1).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced a Hematopoietic Response | Up to Day 28 | A hematopoietic response was defined as an increase in a participant's hemoglobin (Hgb) of ≥1.0 g/dL above the study baseline value for 4 consecutive weeks, in the absence of red blood cell transfusion and/or erythropoiesis-stimulating agents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression (TTP) | Up to 6 months | TTP was defined as the time from date of randomization to date of diagnosis of progressive disease |
| Progression Free Survival (PFS) | Up to 12 months | PFS was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first |
| Overall Survival (OS) | Up to 24 months | OS was defined as the time between randomization and death |
| Overall Response Rate (ORR) | Up to 12 months | Overall Response was defined as the percentage of participants who achieved an objective confirmed complete (CR) or partial response (PR). Response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 guidelines. CR: The disappearance of all known disease and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation and no new non-target lesions and/or unequivocal progression of existing non-target lesions. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. |
| Number of Participants Who Experienced an Improvement in Quality of Life Scores | Up to 6 months | Participants were to be assessed on improvement of quality of life using the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4.0) and the Lung Cancer Symptom Scale (LCSS). The FACIT Fatigue score ranges from 0 to 52, with 0 representing the best outcome and 52 representing the worst outcome. The LCSS is a 9-item patient-rated scale, 6 of which measure major symptoms (loss of appetite, fatigue, cough, dyspnoea, pain, and haemoptysis), and 3 of which are summation items related to total symptomatic distress, activity, and overall quality of life. Participants responses are measured using the mean score on the 9-item visual analogue scales, with 100-mm lines, with 0 representing the best outcome and 100 representing the worst outcome. |
| Area Under the Concentration Versus Time Curve From Time 0 to 28 Days (AUC0-28d) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 28 | AUC0-28d is a measure of the mean concentration levels of a drug in the plasma from time 0 to 28 days. |
| Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 6 months | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Maximum Plasma Concentration (Cmax) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | Cmax is a measure of the maximum amount of drug in the plasma after a dose is given. |
| Time to Maximum Concetration (Tmax) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | Tmax is a measure of the time it takes for a drug to reach maximum concentration in the plasma after the dose is given. |
| Apparent Terminal Half-life (t1/2) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | t1/2 is the elimination half-life of study drug: the time it takes for half of the study drug in the blood plasma to dissipate. |
| Apparent Serum Clearance (CL/F) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | Apparent serum CL is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. |
| Apparent Volume of Distribution (Vz/F) Following a Single Dose of Sotatercept | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. |
| Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Sotatercept Following a Single Dose | Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43 | AUC0-inf is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sotatercept 15 mg Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses. | 14 |
| Sotatercept 30 mg Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses. | 12 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Status not recorded | 9 | 10 |
| Overall Study | Withdrew consent | 0 | 1 |
Baseline characteristics
| Characteristic | Sotatercept 30 mg | Total | Sotatercept 15 mg |
|---|---|---|---|
| Age, Continuous | 68.5 Years STANDARD_DEVIATION 9.1 | 64.7 Years STANDARD_DEVIATION 12.3 | 61.4 Years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 25 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 24 Participants | 13 Participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 14 | 5 / 12 |
| other Total, other adverse events | 14 / 14 | 10 / 11 |
| serious Total, serious adverse events | 4 / 14 | 8 / 11 |
Outcome results
Primary
Number of Participants Who Experienced a Hematopoietic Response
A hematopoietic response was defined as an increase in a participant's hemoglobin (Hgb) of ≥1.0 g/dL above the study baseline value for 4 consecutive weeks, in the absence of red blood cell transfusion and/or erythropoiesis-stimulating agents.
Time frame: Up to Day 28
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sotatercept 15 mg | Number of Participants Who Experienced a Hematopoietic Response | 2 Participants |
| Sotatercept 30 mg | Number of Participants Who Experienced a Hematopoietic Response | 2 Participants |
Secondary
Apparent Serum Clearance (CL/F) of Sotatercept Following a Single Dose
Apparent serum CL is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time frame: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43
Population: All participants who received at least 1 dose of study treatment and had data for CL/F of Sotatercept Following a Single Dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sotatercept 15 mg | Apparent Serum Clearance (CL/F) of Sotatercept Following a Single Dose | 479.36 mL/day | Standard Deviation 254.44 |
| Sotatercept 30 mg | Apparent Serum Clearance (CL/F) of Sotatercept Following a Single Dose | 220.14 mL/day | Standard Deviation 31.17 |
Secondary
Apparent Terminal Half-life (t1/2) of Sotatercept Following a Single Dose
t1/2 is the elimination half-life of study drug: the time it takes for half of the study drug in the blood plasma to dissipate.
Time frame: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43
Population: All participants who received at least 1 dose of study treatment and had data for t1/2 of Sotatercept Following a Single Dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sotatercept 15 mg | Apparent Terminal Half-life (t1/2) of Sotatercept Following a Single Dose | 18.98 Days | Standard Deviation 7.96 |
| Sotatercept 30 mg | Apparent Terminal Half-life (t1/2) of Sotatercept Following a Single Dose | 30.84 Days | Standard Deviation 9.46 |
Secondary
Apparent Volume of Distribution (Vz/F) Following a Single Dose of Sotatercept
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Time frame: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43
Population: All participants who received at least 1 dose of study treatment and had data for Vz/F of Sotatercept Following a Single Dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sotatercept 15 mg | Apparent Volume of Distribution (Vz/F) Following a Single Dose of Sotatercept | 11944.60 mL | Standard Deviation 7172.84 |
| Sotatercept 30 mg | Apparent Volume of Distribution (Vz/F) Following a Single Dose of Sotatercept | 9849.80 mL | Standard Deviation 3449.33 |
Secondary
Area Under the Concentration Versus Time Curve From Time 0 to 28 Days (AUC0-28d) of Sotatercept Following a Single Dose
AUC0-28d is a measure of the mean concentration levels of a drug in the plasma from time 0 to 28 days.
Time frame: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 28
Population: All participants who received at least 1 dose of study treatment and had data for AUC0-28d of Sotatercept Following a Single Dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sotatercept 15 mg | Area Under the Concentration Versus Time Curve From Time 0 to 28 Days (AUC0-28d) of Sotatercept Following a Single Dose | 24443.28 day*ng/mL | Standard Deviation 8130.52 |
| Sotatercept 30 mg | Area Under the Concentration Versus Time Curve From Time 0 to 28 Days (AUC0-28d) of Sotatercept Following a Single Dose | 43977.03 day*ng/mL | Standard Deviation 18490.17 |
Secondary
Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Sotatercept Following a Single Dose
AUC0-inf is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.
Time frame: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43
Population: All participants who received at least 1 dose of study treatment and had data for AUC0-inf of Sotatercept Following a Single Dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sotatercept 15 mg | Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Sotatercept Following a Single Dose | 40145.34 day*ng/mL | Standard Deviation 20680.76 |
| Sotatercept 30 mg | Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Sotatercept Following a Single Dose | 137994.6 day*ng/mL | Standard Deviation 18183.66 |
Secondary
Maximum Plasma Concentration (Cmax) of Sotatercept Following a Single Dose
Cmax is a measure of the maximum amount of drug in the plasma after a dose is given.
Time frame: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43
Population: All participants who received at least 1 dose of study treatment and had data for Cmax of Sotatercept Following a Single Dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sotatercept 15 mg | Maximum Plasma Concentration (Cmax) of Sotatercept Following a Single Dose | 1325.33 ng/mL | Standard Deviation 435.89 |
| Sotatercept 30 mg | Maximum Plasma Concentration (Cmax) of Sotatercept Following a Single Dose | 2069.68 ng/mL | Standard Deviation 842.43 |
Secondary
Number of Participants Who Experienced an Improvement in Quality of Life Scores
Participants were to be assessed on improvement of quality of life using the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4.0) and the Lung Cancer Symptom Scale (LCSS). The FACIT Fatigue score ranges from 0 to 52, with 0 representing the best outcome and 52 representing the worst outcome. The LCSS is a 9-item patient-rated scale, 6 of which measure major symptoms (loss of appetite, fatigue, cough, dyspnoea, pain, and haemoptysis), and 3 of which are summation items related to total symptomatic distress, activity, and overall quality of life. Participants responses are measured using the mean score on the 9-item visual analogue scales, with 100-mm lines, with 0 representing the best outcome and 100 representing the worst outcome.
Time frame: Up to 6 months
Population: Quality of Life parameters were to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed.
Secondary
Number of Participants Who Experienced One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Time frame: Up to approximately 6 months
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sotatercept 15 mg | Number of Participants Who Experienced One or More Adverse Events (AEs) | 14 Participants |
| Sotatercept 30 mg | Number of Participants Who Experienced One or More Adverse Events (AEs) | 10 Participants |
Secondary
Overall Response Rate (ORR)
Overall Response was defined as the percentage of participants who achieved an objective confirmed complete (CR) or partial response (PR). Response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 guidelines. CR: The disappearance of all known disease and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation and no new non-target lesions and/or unequivocal progression of existing non-target lesions. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing.
Time frame: Up to 12 months
Population: ORR was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed.
Secondary
Overall Survival (OS)
OS was defined as the time between randomization and death
Time frame: Up to 24 months
Population: OS was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed.
Secondary
Progression Free Survival (PFS)
PFS was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first
Time frame: Up to 12 months
Population: PFS was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed.
Secondary
Time to Maximum Concetration (Tmax) of Sotatercept Following a Single Dose
Tmax is a measure of the time it takes for a drug to reach maximum concentration in the plasma after the dose is given.
Time frame: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43
Population: All participants who received at least 1 dose of study treatment and had data for Tmax of Sotatercept Following a Single Dose of Sotatercept
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sotatercept 15 mg | Time to Maximum Concetration (Tmax) of Sotatercept Following a Single Dose | 8.16 Days | Standard Deviation 3.78 |
| Sotatercept 30 mg | Time to Maximum Concetration (Tmax) of Sotatercept Following a Single Dose | 12.31 Days | Standard Deviation 7.67 |
Secondary
Time to Progression (TTP)
TTP was defined as the time from date of randomization to date of diagnosis of progressive disease
Time frame: Up to 6 months
Population: TTP was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed.