Trial · NCT02674750
Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations
NCT02674750, Phase 2, Completed, Curis, Inc.; results first posted 2022-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations. Trials, record NCT02674750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02674750
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations
- NCT number
- NCT02674750
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Curis, Inc.
- Conditions
- Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations
- Interventions
- CUDC-907
- First posted
- 2016-02-04
- Last updated
- 2022-04-27
- Results first posted
- 2022-04-27
- Limitations and caveats
- Due to inconclusive efficacy at the interim analysis, enrollment was permanently stopped in August 2017.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 2 Years | Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL) |
| Secondary | Median Progression-free Survival | 1 year | Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL |
| Secondary | Overall Survival (OS) | 1 year | Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL |
| Secondary | Disease Control Rate (DCR) | 1 year | Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL Note: Response is defined using Cheson 2007 criteria. CR=Complete Response; PR=Partial Response; SD=Stable Disease. a. Two-sided exact binomial 95% confidence interval. Revised Response Criteria for Malignant Lymphoma (Cheson 2007) was used for the assessment of response. DCR is defined as the proportion of patients having best response of complete response, partial response, or stable disease. |
| Secondary | Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters | AEs were collected for each participant for the duration that they remained on the study, on average of 4 months | Number of participants and severity of adverse events (AEs), serious adverse events (SAEs), and other safety parameters in patients receiving CUDC-907. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | 2 Years | The analysis of ORR was not performed since central radiographic review was not performed, due to inconclusive efficacy at the interim analysis, enrollment was permanently stopped in August 2017. | ||
| SECONDARY | Median Progression-free Survival | 1 year | Evaluable population; The number of participants in this table include the evaluable participants which is different from the overall number of participants. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 1 year | Evaluable population; The number of participants in this table include the evaluable participants which is different from the overall number of participants. | participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | 1 year | Evaluable population; The number of participants in this table include the evaluable participants which is different from the overall number of participants. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters | AEs were collected for each participant for the duration that they remained on the study, on average of 4 months | Safety Population; The number of participants in this table include the participants evaluable for safety which is different from the overall number of participants. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression-free Survival | Group A | 1.2 | 95% Confidence Interval 1.02 to 1.41 | months | |
| Median Progression-free Survival | Group B | 2.7 | 95% Confidence Interval 1.28 to 4.05 | months | |
| Median Progression-free Survival | Group C | 2.6 | 95% Confidence Interval 1.28 to 21.94 | months | |
| Overall Survival (OS) | Group A | 1 | participants | ||
| Overall Survival (OS) | Group B | 17 | participants | ||
| Overall Survival (OS) | Group C | 2 | participants | ||
| Disease Control Rate (DCR) | Group A | 0.0 | 95% Confidence Interval 0.00 to 84.19 | percentage of participants | |
| Disease Control Rate (DCR) | Group B | 46.4 | 95% Confidence Interval 27.51 to 66.13 | percentage of participants | |
| Disease Control Rate (DCR) | Group C | 44.4 | 95% Confidence Interval 13.70 to 78.80 | percentage of participants | |
| Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters | CUDC-907 | Experienced at least 1 TEAE | 68 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A | 5 | |
| Overall Study | STARTED | Group B | 49 | |
| Overall Study | STARTED | Group C | 16 | |
| Overall Study | COMPLETED | Group A | 0 | |
| Overall Study | COMPLETED | Group B | 4 | |
| Overall Study | COMPLETED | Group C | 4 | |
| Overall Study | NOT COMPLETED | Group A | 5 | |
| Overall Study | NOT COMPLETED | Group B | 45 | |
| Overall Study | NOT COMPLETED | Group C | 12 |
Source ClinicalTrials.gov
Adverse events66
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 | Diarrhea | Gastrointestinal disorders | CUDC-907 | 49 | 68 | 49 |
| other | Nausea | Gastrointestinal disorders | CUDC-907 | 33 | 68 | 33 |
| other | Vomiting | Gastrointestinal disorders | CUDC-907 | 19 | 68 | 19 |
| other | Constipation | Gastrointestinal disorders | CUDC-907 | 14 | 68 | 14 |
| other | Abdominal Pain | Gastrointestinal disorders | CUDC-907 | 12 | 68 | 12 |
| other | Dyspepsia | Gastrointestinal disorders | CUDC-907 | 4 | 68 | 4 |
| other | Fatigue | General disorders | CUDC-907 | 24 | 68 | 24 |
| other | Pyrexia | General disorders | CUDC-907 | 13 | 68 | 13 |
| other | Peripheral edema | General disorders | CUDC-907 | 8 | 68 | 8 |
| other | Asthensia | General disorders | CUDC-907 | 5 | 68 | 5 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CUDC-907 | 17 | 68 |
| Total, other adverse events | CUDC-907 | 68 | 68 |
| Total, serious adverse events | CUDC-907 | 30 | 68 |
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/NCT02674750
GET https://conductscience.org/api/trials/v1/NCT02674750/events?page=2