Trial · NCT03593915
A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
NCT03593915, Phase 1, Phase 2, Terminated, Sumitomo Pharma America, Inc.; results first posted 2022-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS. Trials, record NCT03593915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03593915
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
- NCT number
- NCT03593915
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Myelodysplastic Syndromes (MDS)
- Interventions
- Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine
- First posted
- 2018-07-20
- Last updated
- 2023-11-09
- Results first posted
- 2022-10-21
- Limitations and caveats
A business decision was made to stop enrollment and the study was discontinued on 17 November 2020. Consistent with Food and Drug Administration and International Council for Harmonisation guidance on the content for abbreviated and synoptic CSRs, only safety data are analyzed and reported.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events and Serious Adverse Events | From the time of first dose to 30 days after the last dose, an average of 33.7 weeks. | Assessment of safety of alvocidib administered in combination with either decitabine (DEC) or azacitidine (AZA) by reporting of adverse events and serious adverse events |
| Primary | Tolerability of Alvocidib as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) as Observed in Cycle 1 | Cycle 1 (28 days) | The DLTs are defined as follows based on the NCI CTCAE v5.0: Must be at least possibly related to Alvocidib; Any Gr 4 nonhematologic toxicity; Gr 3 nonhematologic toxicity that does not resolve to ≤Gr 2 in 48 hours; Gr 3 diarrhea, mucositis, nausea, or vomiting will be considered dose limiting only if resolution to ≤Gr 2 requires \>7 days; and ≥Grade 3 creatinine elevation that does not resolve to \<G2 within 7 days. |
| Secondary | Determination of the Complete Response Rate | From the date of first treatment, every 8 weeks, for the first 6 cycles, for an average of 26 weeks | The calculation for Complete Response Rate is as follows: complete response \[CR\] / complete response with incomplete blood count recovery \[CRi\] / CRmarrow / partial response \[PR\] / hematologic improvement \[HI\] |
| Secondary | Improvement in Transfusion Dependence | Duration of study treatment up to 6 months | Determine if treatment with alvocidib administered in sequence after DEC or AZA resulted in improvements in transfusion dependence |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events and Serious Adverse Events | From the time of first dose to 30 days after the last dose, an average of 33.7 weeks. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Tolerability of Alvocidib as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) as Observed in Cycle 1 | Cycle 1 (28 days) | Sponsor's decision to terminate further development of the alvocidib program. Data collection and analysis were therefore not conducted as planned. | ||
| SECONDARY | Determination of the Complete Response Rate | From the date of first treatment, every 8 weeks, for the first 6 cycles, for an average of 26 weeks | Sponsor's decision to terminate further development of the alvocidib program. Data collection and analysis were therefore not conducted as planned. | ||
| SECONDARY | Improvement in Transfusion Dependence | Duration of study treatment up to 6 months | Sponsor's decision to terminate further development of the alvocidib program. Data collection and analysis were not conducted as planned. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events and Serious Adverse Events | ALV-DEC: Cohort 1 | 3 | Participants | ||
| Number of Participants With Adverse Events and Serious Adverse Events | ALV-DEC: Cohort 2 | 3 | Participants | ||
| Number of Participants With Adverse Events and Serious Adverse Events | ALV-DEC: Cohort 3 | 3 | Participants | ||
| Number of Participants With Adverse Events and Serious Adverse Events | ALV-DEC: Cohort 4 | 4 | Participants | ||
| Number of Participants With Adverse Events and Serious Adverse Events | ALV-AZA: Cohort 5 | 3 | Participants | ||
| Number of Participants With Adverse Events and Serious Adverse Events | ALV-AZA: Cohort 6 | 4 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ALV-DEC: Cohort 1 | 3 | |
| Overall Study | STARTED | ALV-DEC: Cohort 2 | 3 | |
| Overall Study | STARTED | ALV-DEC: Cohort 3 | 3 | |
| Overall Study | STARTED | ALV-DEC: Cohort 4 | 4 | |
| Overall Study | STARTED | ALV-AZA: Cohort 5 | 3 | |
| Overall Study | STARTED | ALV-AZA: Cohort 6 | 4 | |
| Overall Study | COMPLETED | ALV-DEC: Cohort 1 | 3 | |
| Overall Study | COMPLETED | ALV-DEC: Cohort 2 | 3 | |
| Overall Study | COMPLETED | ALV-DEC: Cohort 3 | 3 | |
| Overall Study | COMPLETED | ALV-DEC: Cohort 4 | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,098
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 | Diarrhoea | Gastrointestinal disorders | ALV-DEC: Cohort 1 | 2 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | ALV-DEC: Cohort 2 | 2 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | ALV-DEC: Cohort 3 | 3 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | ALV-DEC: Cohort 4 | 4 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | ALV-AZA: Cohort 5 | 2 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | ALV-AZA: Cohort 6 | 2 | 4 | |
| other | Nausea | Gastrointestinal disorders | ALV-DEC: Cohort 1 | 2 | 3 | |
| other | Nausea | Gastrointestinal disorders | ALV-DEC: Cohort 2 | 1 | 3 | |
| other | Nausea | Gastrointestinal disorders | ALV-DEC: Cohort 3 | 3 | 3 | |
| other | Nausea | Gastrointestinal disorders | ALV-DEC: Cohort 4 | 4 | 4 |
1 to 10 of 1,098Source ClinicalTrials.gov
See all 1,098 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ALV-DEC: Cohort 1 | 3 | 3 |
| Total, all-cause mortality | ALV-DEC: Cohort 2 | 3 | 3 |
| Total, all-cause mortality | ALV-DEC: Cohort 3 | 3 | 3 |
| Total, all-cause mortality | ALV-DEC: Cohort 4 | 4 | 4 |
| Total, all-cause mortality | ALV-AZA: Cohort 5 | 3 | 3 |
| Total, all-cause mortality | ALV-AZA: Cohort 6 | 4 | 4 |
| Total, other adverse events | ALV-DEC: Cohort 1 | 3 | 3 |
| Total, other adverse events | ALV-DEC: Cohort 2 | 3 | 3 |
| Total, other adverse events | ALV-DEC: Cohort 3 | 3 | 3 |
| Total, other adverse events | ALV-DEC: Cohort 4 | 4 | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03593915
GET https://conductscience.org/api/trials/v1/NCT03593915/events?page=2