Trial · NCT01202877
PKC412 and 5-Azacytidine
NCT01202877, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2016-11-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PKC412 and 5-Azacytidine. Trials, record NCT01202877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01202877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PKC412 and 5-Azacytidine
- NCT number
- NCT01202877
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia
- Interventions
- 5-azacytidine, PKC412
- First posted
- 2010-09-16
- Last updated
- 2018-10-16
- Results first posted
- 2016-11-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | 6 months | Criteria for response per international working group for Myelodysplastic Syndrome (MDS) \& acute myeloid leukemia (AML) where responders obtained a complete remission (CR), a CR with incomplete bone marrow recovery (CRi), a morphologic leukemia-free status (MLFS), or a partial remission (PR). CR: \<5% bone marrow blasts, neutrophil count\>1.0 X10⁹/L, \& platelet count\>100 X10⁹/L. CRi: all CR criteria except residual neutropenia (\<1.0 X10⁹/L) or thrombocytopenia (\<100 X10⁹/L). MLFS: \<5% blasts in bone marrow regardless of neutrophil \& platelet count in peripheral blood. PR: all CR criteria, except reduction\> 50% in bone marrow blasts, but still \>5%. Clinical responses evaluated using RECIST version 1.1 criteria after every two cycles, with confirmation of clinical response at 4 weeks after achieving response. |
| Primary | Overall Response (OR) Within 6 Months | 6 Months | Overall response defined as number of participants with response as follows: (OR = CR \[complete response (CR) rate\] + CRi \[complete remission with incomplete count recovery\] + PR \[partial remission\] + HI \[hematologic improvement\]) within 6 months of treatment initiation. complete remission (CR), a CR with incomplete bone marrow recovery (CRi), a morphologic leukemia-free status (MLFS), or a partial remission (PR). CR: \<5% bone marrow blasts, neutrophil count\>1.0 X10⁹/L, \& platelet count\>100 X10⁹/L. CRi: all CR criteria except residual neutropenia (\<1.0 X10⁹/L) or thrombocytopenia (\<100 X10⁹/L). MLFS: \<5% blasts in bone marrow regardless of neutrophil \& platelet count in peripheral blood. PR: all CR criteria, except reduction\> 50% in bone marrow blasts, but still \>5%. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | 6 months | participants | NUMBER | |
| PRIMARY | Overall Response (OR) Within 6 Months | 6 Months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Phase I: 5-azacytidine + PKC412 25 mg | Complete Remission (CR) | 0 | participants | |
| Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Phase I: 5-azacytidine + PKC412 50 mg | Complete Remission (CR) | 0 | participants | |
| Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Phase II: 5-azacytidine + PKC412 | Complete Remission (CR) | 1 | participants | |
| Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Phase I: 5-azacytidine + PKC412 25 mg | Complete w/Incomplete Bone Marrow Recovery (CRi) | 1 | participants | |
| Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Phase I: 5-azacytidine + PKC412 50 mg | Complete w/Incomplete Bone Marrow Recovery (CRi) | 1 | participants | |
| Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Phase II: 5-azacytidine + PKC412 | Complete w/Incomplete Bone Marrow Recovery (CRi) | 4 | participants | |
| Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Phase I: 5-azacytidine + PKC412 25 mg | Morphologic Leukemia-Free Status (MLFS) | 0 | participants | |
| Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Phase I: 5-azacytidine + PKC412 50 mg | Morphologic Leukemia-Free Status (MLFS) | 0 | participants | |
| Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Phase II: 5-azacytidine + PKC412 | Morphologic Leukemia-Free Status (MLFS) | 6 | participants | |
| Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Phase I: 5-azacytidine + PKC412 25 mg | Partial Remission (PR) | 0 | participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I: 5-azacytidine + PKC412 25 mg | 6 | |
| Overall Study | STARTED | Phase I: 5-azacytidine + PKC412 50 mg | 8 | |
| Overall Study | STARTED | Phase II: 5-azacytidine + PKC412 | 40 | |
| Overall Study | COMPLETED | Phase I: 5-azacytidine + PKC412 25 mg | 6 | |
| Overall Study | COMPLETED | Phase I: 5-azacytidine + PKC412 50 mg | 7 | |
| Overall Study | COMPLETED | Phase II: 5-azacytidine + PKC412 | 34 | |
| Overall Study | NOT COMPLETED | Phase I: 5-azacytidine + PKC412 25 mg | 0 | |
| Overall Study | NOT COMPLETED | Phase I: 5-azacytidine + PKC412 50 mg | 1 | |
| Overall Study | NOT COMPLETED | Phase II: 5-azacytidine + PKC412 | 6 |
Source ClinicalTrials.gov
Adverse events171
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 | Anemia | Blood and lymphatic system disorders | Phase I: 5-azacytidine + PKC412 25 mg | 6 | 6 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Phase I: 5-azacytidine + PKC412 50 mg | 8 | 8 | 8 |
| other | Anemia | Blood and lymphatic system disorders | Phase II: 5-azacytidine + PKC412 | 40 | 40 | 40 |
| other | Acute renal failure | Renal and urinary disorders | Phase I: 5-azacytidine + PKC412 25 mg | 0 | 6 | 0 |
| other | Acute renal failure | Renal and urinary disorders | Phase I: 5-azacytidine + PKC412 50 mg | 1 | 8 | 1 |
| other | Acute renal failure | Renal and urinary disorders | Phase II: 5-azacytidine + PKC412 | 3 | 40 | 3 |
| other | Hemorrhage/Bleeding | Blood and lymphatic system disorders | Phase I: 5-azacytidine + PKC412 25 mg | 0 | 6 | 0 |
| other | Hemorrhage/Bleeding | Blood and lymphatic system disorders | Phase I: 5-azacytidine + PKC412 50 mg | 0 | 8 | 0 |
| other | Hemorrhage/Bleeding | Blood and lymphatic system disorders | Phase II: 5-azacytidine + PKC412 | 8 | 40 | 8 |
| other | Constipation | Gastrointestinal disorders | Phase I: 5-azacytidine + PKC412 25 mg | 1 | 6 | 1 |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: 5-azacytidine + PKC412 25 mg | ||
| Total, all-cause mortality | Phase I: 5-azacytidine + PKC412 50 mg | ||
| Total, all-cause mortality | Phase II: 5-azacytidine + PKC412 | ||
| Total, other adverse events | Phase I: 5-azacytidine + PKC412 25 mg | 6 | 6 |
| Total, other adverse events | Phase I: 5-azacytidine + PKC412 50 mg | 8 | 8 |
| Total, other adverse events | Phase II: 5-azacytidine + PKC412 | 40 | 40 |
| Total, serious adverse events | Phase I: 5-azacytidine + PKC412 25 mg | 5 | 6 |
| Total, serious adverse events | Phase I: 5-azacytidine + PKC412 50 mg | 5 | 8 |
| Total, serious adverse events | Phase II: 5-azacytidine + PKC412 | 29 | 40 |
Source ClinicalTrials.gov
Papers0
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/NCT01202877
GET https://conductscience.org/api/trials/v1/NCT01202877/events?page=2