Solid TumorsPhase 2NCT01190644
Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors
A Phase 2 study testing Sotatercept in people with Solid Tumors, run by Merck Sharp & Dohme LLC at 3 sites in United States.
Trial summary
What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has determined that all of these goals could be obtained by an intense 10-patient sotatercept (ACE-011) pharmacodynamic study, completed by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Sotatercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2010to 29 Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥18 years of age.
- Histologically confirmed diagnosis of a solid tumor malignancy documented by cytology or biopsy.
- Presence of metastatic disease.
- Hemoglobin value between ≥8.0 to <11.0 g/dL (≥80 to <110 g/L).
- ≥28 days must have elapsed (prior to pre-dose red blood cell mass / plasma volume test) since previous treatment with erythropoiesis-stimulating agent (including concurrent treatment with intravenous [IV] iron).
- ≥28 days must have elapsed (prior to Day 1) since the last red blood cell transfusion and receipt of ≤2 units of blood in the past 56 days (prior to Day 1).
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 1.
Who cannot join
- At the time of screening, participants who have any grade ≥3 toxicity (according to the currently active minor version of NCI CTCAE v4.0) except for the following disease-related toxicities:
- Hematological events - anemia, thrombocytopenia, neutropenia
- Non-hematological events - nausea, vomiting, fatigue, muscle or bone/joint pain
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Saint Agnes Healthcare
Baltimore, Maryland, 21229
Weinberg Cancer Institution at Franklin Square
Baltimore, Maryland, 21237
Pennsylvania Oncology
Philadelphia, Pennsylvania, 19106
About this study
Official title: A Phase 2, Open-Label, Pharmacodynamic Study to Evaluate the Effect of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Subjects With Solid Tumors
What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has determined that all of these goals could be obtained by an intense 10-patient sotatercept (ACE-011) pharmacodynamic study, completed by two well-known experts in the red cell production field.
- Conditions
- Solid Tumors
- Being tested
- Sotatercept
- Keywords
- Red Blood Cell Mass, Plasma Volume, Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptDrug
Also called ACE 011
single 35 mg SC dose of sotatercept on study Day 1, Day 43, and Day 85
| Study group | Role | What they receive |
|---|---|---|
| Sotatercept | Experimental | Participants will receive a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85. Receives: Drug: Sotatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept
Blood samples were to be collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in red blood cell mass following a single dose of sotatercept.
Measured: Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28
Secondary outcomes (7)
Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept
Blood samples were collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in plasma volume following a single dose of sotatercept.
Measured: Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28
Change From Baseline in Absolute Reticulocyte Count
Blood samples were to be collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in absolute reticulocyte count.
Measured: Baseline (Day 1, pre-dose) and Day 211
Change From Baseline in Erythropoietin Levels
Blood samples were collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in erythropoietin levels.
Measured: Baseline (Day 1, pre-dose) and Day 211
Change From Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept
Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype A following a single dose of sotatercept.
Measured: Baseline (Day 1, pre-dose) and Day 29
Change From Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept
Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype A2 following a single dose of sotatercept.
Measured: Baseline (Day 1, pre-dose) and Day 29
Change From Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept
Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype C following a single dose of sotatercept.
Measured: Baseline (Day 1, pre-dose) and Day 29
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.
Measured: Up to approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study start1 Jun 2010
- Primary completion18 Sep 2012
- Study completion29 Oct 2012
Why it stopped: Isotope needed to conduct RBC/PV analysis (primary endpoint) no longer available from manufacturer. No alternatives available for use.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190644
- Sponsor's protocol ID
- 7962-016
- Other IDs
- ACE-011-ST-001
- Status last verified
- Nov 2023
- First submitted
- 21 Jul 2010
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Cappellini MD, Porter J, Origa R, Forni GL, Voskaridou E, Galacteros F, Taher AT, Arlet JB, Ribeil JA, Garbowski M, Graziadei G, Brouzes C, Semeraro M, Laadem A, Miteva D, Zou J, Sung V, Zinger T, Attie KM, Hermine O. Sotatercept, a novel transforming growth factor beta ligand trap, improves anemia in beta-thalassemia: a phase II, open-label, dose-finding study. Haematologica. 2019 Mar;104(3):477-484. doi: 10.3324/haematol.2018.198887. Epub 2018 Oct 18.
PubMed 30337358
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Pharmacodynamic Study to Evaluate the Effect of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01190644
- Acronym / sponsor ID
- 7962-016
- Conditions
- Solid Tumors
- Keywords
- Red Blood Cell Mass, Plasma Volume, Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Isotope needed to conduct RBC/PV analysis (primary endpoint) no longer available from manufacturer. No alternatives available for use.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 18 Sep 2012 (actual)
- Study completion
- 29 Oct 2012 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Posted 29 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has determined that all of these goals could be obtained by an intense 10-patient sotatercept (ACE-011) pharmacodynamic study, completed by two well-known experts in the red cell production field.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sotatercept | Experimental | Drug: SotaterceptParticipants will receive a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women ≥18 years of age.
- Histologically confirmed diagnosis of a solid tumor malignancy documented by cytology or biopsy.
- Presence of metastatic disease.
- Hemoglobin value between ≥8.0 to <11.0 g/dL (≥80 to <110 g/L).
- ≥28 days must have elapsed (prior to pre-dose red blood cell mass / plasma volume test) since previous treatment with erythropoiesis-stimulating agent (including concurrent treatment with intravenous [IV] iron).
Key exclusion criteria (3 listed)
- At the time of screening, participants who have any grade ≥3 toxicity (according to the currently active minor version of NCI CTCAE v4.0) except for the following disease-related toxicities:
- Hematological events - anemia, thrombocytopenia, neutropenia
- Non-hematological events - nausea, vomiting, fatigue, muscle or bone/joint pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotaterceptAlso: ACE 011single 35 mg SC dose of sotatercept on study Day 1, Day 43, and Day 85 | Drug | Sotatercept |
Primary outcome
Change From Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept
Time frame: Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28
Blood samples were to be collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in red blood cell mass following a single dose of sotatercept.
7 secondary outcomes
Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept
Time frame: Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28
Change From Baseline in Absolute Reticulocyte Count
Time frame: Baseline (Day 1, pre-dose) and Day 211
Change From Baseline in Erythropoietin Levels
Time frame: Baseline (Day 1, pre-dose) and Day 211
Change From Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept
Time frame: Baseline (Day 1, pre-dose) and Day 29
Change From Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept
Time frame: Baseline (Day 1, pre-dose) and Day 29
Change From Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept
Time frame: Baseline (Day 1, pre-dose) and Day 29
Number of Participants Who Experienced One or More Adverse Events (AEs)
Time frame: Up to approximately 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30337358Cappellini MD, Porter J, Origa R, Forni GL, Voskaridou E, Galacteros F, Taher AT, Arlet JB, Ribeil JA, Garbowski M, Graziadei G, Brouzes C, Semeraro M, Laadem A, Miteva D, Zou J, Sung V, Zinger T, Attie KM, Hermine O. Sotatercept, a novel transforming growth factor beta ligand trap, improves anemia in beta-thalassemia: a phase II, open-label, dose-finding study. Haematologica. 2019 Mar;104(3):477-484. doi: 10.3324/haematol.2018.198887. Epub 2018 Oct 18.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sotatercept in people with Solid Tumors, run by Merck Sharp & Dohme LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept (time frame: Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01190644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.