Trial · NCT06159491
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting toxicity of Pacritinib in combination with Azacitidine | at the end of one 28-day cycle | Phase 1: The recommended phase 2 dose (RP2D) for the combination of pacritinib with azacitidine will be determined based on the dose limiting toxicity (DLT) rate, defined as the proportion of participants in the DLT-evaluable population that experience a DLT within the first 4 weeks (1 cycle) of initiating treatment at the recommended phase 2 dose. |
| Primary | Proportion of participants that achieve clinical benefit or better measured using 2015 MDS/MPN IWG Criteria | 24 weeks (6 cycles, each cycle is 28 days) | Phase 2: The preliminary efficacy of pacritinib in combination with azacitidine will be defined as the proportion of participants that achieve clinical benefit or better within 24 weeks (6 cycles, each cyce) of initiating treatment. Clinical benefit as defined by 2015 MDS/MPN IWG criteria within erythroid response, platelet response, neutrophil response, spleen response or symptom response. |
| Primary | Overall Response Rate (ORR) to measure clinical benefit | 24 weeks (6 cycles, each cycle is 28 days) | Clinical benefit will be determined by evaluating overall response rate (ORR) which is defined by complete remission. |
| Secondary | Number of Adverse events Grade 3 or higher measured using NCI CTCAE Version 5.0 | up to 30 days after last study dose (up to 6 cycles, each cycle 28 days) | Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 5.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment. |
| Secondary | Duration of Response (DOR) to measure efficacy | up to 24 months | Preliminary efficacy of the combination of pacritinib with azacitidine as determined by duration of response (DOR). DOR is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. |
| Secondary | Overall Survival (OS) to measure efficacy | up to 24 months | Preliminary efficacy of the combination of pacritinib with azacitidine as determined by duration of overall survival (OS). OS is defined as the time from the first dose of study treatment to the date of death (whatever the cause). |
| Secondary | Disease Free Survival (DFS) to measure efficacy | up to 24 months | Preliminary efficacy of the combination of pacritinib with azacitidine as determined by disease free survival (DFS). DFS is defined as the time from randomization to recurrence of tumor or death. |
| Secondary | Change in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SASF TSS) | Baseline and after 3 and 6 cycles of therapy, each cycle is 28 days | Change in MPN-SAF TSS to determine differences in health-related quality of life before and after treatment. MPN-SAF TSS has a possible range of 0-100, with higher score indicating higher level of symptom severity. |
| Secondary | Percentage of patients achieving "very much" or "much" in the Patient Global Impression of Change (PGIC) | Baseline and after 3 and 6 cycles of therapy, each cycle is 28 days | Patient Global Impression of Change (PGIC) to determine differences in health-related quality of life before and after treatment. Percentage of patients achieving "very much" or "much" improved as measured by Patient Global Impression of Change (PGIC) will be recorded. The Patient's Global Impression of Change (PGIC) will be used to assess self-reported relieving effect. It will evaluate pain from no change (score 0-1), minimally improved (score 2-3), much improved (score 4-5), and very much improved (score 6-7). Full score from 0-7, with higher score indicating more improvement. |
| Secondary | Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score | Baseline and after 3 and 6 cycles of therapy, each cycle is 28 days | Change in EORTC-QLQ-C30 score to determine differences in health-related quality of life before and after treatment. EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Subscales and Total Scale are averaged, and transformed to 0-100 scale; with higher score indicating better quality of life |
| Secondary | Change in Palpable Spleen Size | Baseline and after 3 and 6 cycles of therapy, each cycle is 28 days | Change in palpable spleen size to determine differences in health-related quality of life before and after treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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