Trial · NCT01284348
To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer
NCT01284348, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2023-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer. Trials, record NCT01284348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01284348
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer
- NCT number
- NCT01284348
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Anemia, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small-Cell Lung, Bladder Cancer, Cancer of Head and Neck, Uterine Cervical Cancer
- Interventions
- Sotatercept 15 mg, Sotatercept 30 mg
- First posted
- 2011-01-27
- Last updated
- 2024-08-29
- Other registries' IDs
- eudract:2010-022561-10
- Results first posted
- 2023-10-31
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | Overall Survival (OS) | Up to 24 months | OS was defined as the time between randomization and death |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced a Hematopoietic Response | Up to Day 28 | All participants who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 6 months | All participants who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Progression (TTP) | Up to 6 months | 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. | ||
| SECONDARY | Progression Free Survival (PFS) | Up to 12 months | 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 | Overall Survival (OS) | Up to 24 months | 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 | Overall Response Rate (ORR) | Up to 12 months | 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 | Number of Participants Who Experienced an Improvement in Quality of Life Scores | Up to 6 months | 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 | 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 | All participants who received at least 1 dose of study treatment and had data for AUC0-28d of Sotatercept Following a Single Dose | day*ng/mL | MEAN |
| SECONDARY | 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 | All participants who received at least 1 dose of study treatment and had data for AUC0-inf of Sotatercept Following a Single Dose | day*ng/mL | MEAN |
| SECONDARY | 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 | All participants who received at least 1 dose of study treatment and had data for Cmax of Sotatercept Following a Single Dose | ng/mL | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced a Hematopoietic Response | Sotatercept 15 mg | 2 | Participants | ||
| Number of Participants Who Experienced a Hematopoietic Response | Sotatercept 30 mg | 2 | Participants | ||
| Number of Participants Who Experienced One or More Adverse Events (AEs) | Sotatercept 15 mg | 14 | Participants | ||
| Number of Participants Who Experienced One or More Adverse Events (AEs) | Sotatercept 30 mg | 10 | Participants | ||
| Area Under the Concentration Versus Time Curve From Time 0 to 28 Days (AUC0-28d) of Sotatercept Following a Single Dose | Sotatercept 15 mg | 24443.28 | Standard Deviation 8130.52 | day*ng/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 to 28 Days (AUC0-28d) of Sotatercept Following a Single Dose | Sotatercept 30 mg | 43977.03 | Standard Deviation 18490.17 | day*ng/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Sotatercept Following a Single Dose | Sotatercept 15 mg | 40145.34 | Standard Deviation 20680.76 | day*ng/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Sotatercept Following a Single Dose | Sotatercept 30 mg | 137994.6 | Standard Deviation 18183.66 | day*ng/mL | |
| Maximum Plasma Concentration (Cmax) of Sotatercept Following a Single Dose | Sotatercept 15 mg | 1325.33 | Standard Deviation 435.89 | ng/mL | |
| Maximum Plasma Concentration (Cmax) of Sotatercept Following a Single Dose | Sotatercept 30 mg | 2069.68 | Standard Deviation 842.43 | ng/mL |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sotatercept 15 mg | 14 | |
| Overall Study | STARTED | Sotatercept 30 mg | 12 | |
| Overall Study | Treated | Sotatercept 15 mg | 14 | |
| Overall Study | Treated | Sotatercept 30 mg | 11 | |
| Overall Study | COMPLETED | Sotatercept 15 mg | 4 | |
| Overall Study | COMPLETED | Sotatercept 30 mg | 0 | |
| Overall Study | NOT COMPLETED | Sotatercept 15 mg | 10 | |
| Overall Study | NOT COMPLETED | Sotatercept 30 mg | 12 |
Source ClinicalTrials.gov
Adverse events298
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Sotatercept 15 mg | 4 | 14 | 34 |
| other | Anaemia | Blood and lymphatic system disorders | Sotatercept 30 mg | 6 | 11 | 17 |
| other | Leukopenia | Blood and lymphatic system disorders | Sotatercept 15 mg | 2 | 14 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Sotatercept 30 mg | 1 | 11 | 4 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Sotatercept 15 mg | 1 | 14 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Sotatercept 30 mg | 0 | 11 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Sotatercept 15 mg | 3 | 14 | 23 |
| other | Neutropenia | Blood and lymphatic system disorders | Sotatercept 30 mg | 4 | 11 | 9 |
| other | Pancytopenia | Blood and lymphatic system disorders | Sotatercept 15 mg | 1 | 14 | 1 |
| other | Pancytopenia | Blood and lymphatic system disorders | Sotatercept 30 mg | 0 | 11 | 0 |
1 to 10 of 298Source ClinicalTrials.gov
See all 298 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sotatercept 15 mg | 6 | 14 |
| Total, all-cause mortality | Sotatercept 30 mg | 5 | 12 |
| Total, other adverse events | Sotatercept 15 mg | 14 | 14 |
| Total, other adverse events | Sotatercept 30 mg | 10 | 11 |
| Total, serious adverse events | Sotatercept 15 mg | 4 | 14 |
| Total, serious adverse events | Sotatercept 30 mg | 8 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26370220 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sotatercept 15 mg vs Sotatercept 30 mg: Number of Participants Who Experienced One or More Adverse Events (AEs) | Trial comparisons |
| Sotatercept 15 mg vs Sotatercept 30 mg: Number of Participants Who Experienced a Hematopoietic Response | Trial comparisons |
| Sotatercept 15 mg vs Sotatercept 30 mg: deaths from any cause | Trial comparisons |
| Sotatercept 15 mg vs Sotatercept 30 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01284348
GET https://conductscience.org/api/trials/v1/NCT01284348/events?page=2