Trial · NCT01742988
Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma
NCT01742988, Phase 1, Completed, Curis, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma. Trials, record NCT01742988. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01742988
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma
- NCT number
- NCT01742988
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 106 participants, actual
- Lead sponsor
- Curis, Inc.
- Conditions
Lymphoma, Relapsed Lymphoma, Refractory Lymphoma, Relapsed and/or Refractory Lymphoma, Relapsed Ddiffuse Large B-Cell Lymphoma (DLBCL), Refractory Diffuse Large B-Cell Lymphoma (DLBCL), Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma (DLBCL), Double-hit Lymphoma (DHL), Triple-hit Lymphoma (THL), Double-expressor Lymphoma (DEL), High-grade B-cell Lymphoma (HGBL)
- Interventions
- fimepinostat, Rituximab, venetoclax
- First posted
- 2012-12-06
- Last updated
- 2021-05-06
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oral fimepinostat (CUDC-907) in combination with venetoclax and rituximab | At the end of cycle 1 or 2 (each cycle is 21 days) | To be evaluated in patients with relapsed and/or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). Within any given study arm, the highest dose level studied at which fewer than 2 out of 6 subjects (\< 33%) experience a dose limiting toxicity (DLT). |
| Primary | To assess the safety and tolerability of fimepinostat in combination with anti-cancer regimens by evaluating the number of participants with adverse events assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE, v4.0). | 18 months | Number of participants with adverse events assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE, v4.0). |
| Primary | To evaluate the efficacy of fimepinostat in combination with anti-cancer regimens by evaluating ORR | 24 months | ORR assessments as measured using Lugano criteria. |
| Primary | To evaluate the efficacy of fimepinostat in combination with anti-cancer regimens by evaluating DOR | 24 months | DOR assessments as measured using Lugano criteria. |
| Secondary | To assess pharmacokinetics (PK) of fimepinostat when administered in combination with anti-cancer regimens as measured by area under the concentration-time curve (AUC). | Pre-dose to 21 - 28 days post dose | Pharmacokinetic parameters will include area under the concentration-time curve (AUC). |
| Secondary | To assess pharmacokinetics (PK) of fimepinostat when administered in combination with anti-cancer regimens as measured by maximum plasma concentration (Cmax). | Pre-dose to 21 - 28 days post dose | Pharmacokinetic parameters will include maximum plasma concentration (Cmax). |
| Secondary | To assess pharmacokinetics (PK) of fimepinostat when administered in combination with anti-cancer regimens as measured by half-life (T1/2). | Pre-dose to 21 - 28 days post dose | Pharmacokinetic parameters will include half-life (T1/2). |
| Secondary | To assess pharmacokinetics (PK) of fimepinostat when administered in combination with anti-cancer regimens as measured by clearance (Cl). | Pre-dose to 21 - 28 days post dose | Pharmacokinetic parameters will include clearance (Cl). |
| Secondary | To assess pharmacokinetics (PK) of fimepinostat when administered in combination with anti-cancer regimens as measured by volume of distribution (Vd). | Pre-dose to 21 - 28 days post dose | Pharmacokinetic parameters will include volume of distribution (Vd). |
| Secondary | To assess PK of venetoclax when administered in combination with fimepinostat as measured by area under the concentration-time curve (AUC). | Pre-dose to 21 - 28 days post dose | Pharmacokinetic parameters will include area under the concentration-time curve (AUC). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01742988
GET https://conductscience.org/api/trials/v1/NCT01742988/registered