Trial · NCT01998828
Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia
NCT01998828, Phase 2, Terminated, Sierra Oncology LLC - a GSK company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia. Trials, record NCT01998828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01998828
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia
- NCT number
- NCT01998828
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- Sierra Oncology LLC - a GSK company
- Conditions
- Polycythemia Vera, Essential Thrombocythemia
- Interventions
- Momelotinib
- First posted
- 2013-12-02
- Last updated
- 2020-04-20
- Other registries' IDs
- eudract:2013-004105-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate | Up to 24 weeks | For the PV Cohort, overall response rate (ORR) is defined as the proportion of participants with all of the following at some point during the treatment period: * Hematocrit \< 45% in the absence of phlebotomy that lasts at least 4 weeks * White blood cell (WBC) count \< 10 x 10\^9/L that lasts at least 4 weeks * Platelet count ≤ 400 x 10\^9/L that lasts at least 4 weeks * Resolution of palpable splenomegaly that lasts at least 4 weeks For the ET Cohort, overall response rate is defined as the proportion of participants with all of the following at some point during the treatment period: * WBC count \< 10 x 10\^9/L that lasts at least 4 weeks * Platelet count ≤ 400 x 10\^9/L that lasts at least 4 weeks * Resolution of palpable splenomegaly that lasts at least 4 weeks |
| Secondary | Confirmed overall response rate | Up to 24 weeks | Confirmed overall response rate is defined as the proportion of participants who meet all the criteria listed for the primary endpoints of PV or ET, sustained for at least 12 weeks. |
| Secondary | Proportion of participants with hematocrit < 45% in the absence of phlebotomy that lasts at least 4 weeks | Up to 24 weeks | |
| Secondary | Proportion of participants with WBC < 10 x 10^9/L that lasts at least 4 weeks | Up to 24 weeks | |
| Secondary | Proportion of participants with platelet count ≤ 400 x 10^9/L that lasts at least 4 weeks | Up to 24 weeks | |
| Secondary | Proportion of participants with resolution of palpable splenomegaly that lasts at least 4 weeks | Up to 24 weeks | |
| Secondary | Proportion of participants with ≥ 10 point decrease in modified Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPNSAF TSS) compared to baseline that lasts at least 12 weeks | Up to 24 weeks |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28622623 | DERIVED |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01998828
GET https://conductscience.org/api/trials/v1/NCT01998828/registered