Trial · NCT02757248
Ph1 Volasertib Plus Romidepsin in R/R PTCL and CTCL
NCT02757248, Phase 1, Withdrawn, Anne Beaven, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ph1 Volasertib Plus Romidepsin in R/R PTCL and CTCL. Trials, record NCT02757248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02757248
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph1 Volasertib Plus Romidepsin in R/R PTCL and CTCL
- NCT number
- NCT02757248
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- Anne Beaven, MD
- Conditions
- PTCL, CTCL
- Interventions
- Volasertib, Romidepsin
- First posted
- 2016-05-02
- Last updated
- 2016-12-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose | 12 months or until 2 DLTs are experienced in a cohort | Determine the maximum tolerated dose (MTD) of the combination of romidepsin and volasertib in patients with relapsed/refractory peripheral T cell and cutaneous T cell lymphoma. |
| Secondary | Overall Response Rate | 24 months | Evaluate the overall response rate (ORR) to the combination of romidepsin and volasertib in patients with relapsed/refractory peripheral T cell and cutaneous t cell lymphoma. |
| Secondary | Gene Expression Signature | 60 months | Define 1) genes expressed at significantly different levels (using linear analysis or the Wilxocon rank sum test and p\< 0.05 as significance threshold) in tumor biopsies taken before treatment from patients exhibiting a clinical response versus non-responders to romidepsin/volasertib by analysis of levels of mRNA gene transcription by mRNA whole transcriptome sequencing (RNA-seq) Comparison of baseline to interim 8 week biopsy samples will be used to define changes in gene expression induced by combination treatment. These will be derived for each patient by using paired T tests for RNA sequencing FPKM values with correction for multiple comparisons via FDR calculation by the Benjamini-Hochberg method (a cutoff of FDR \< 0.05 will be used to define genes included in the treatment gene signature). |
| Secondary | Gene Mutation Analysis | 60 months | Define 2) and 2) define mutations associated with primary (lack of clinical response) or acquired resistance (relapse or loss of response after first clinical response) to romidepsin/volasertib by analysis of tumor genetic sequences by using RNA-seq metholodies on tumor samples taken before or after treatment with romidepsin/volasertib and analysis of paired normal DNA sequence(s). Mutations for relapse samples will be obtained by comparing transcriptome profiles before and after development of resistance to romidepsin/volasertib. Specifically, we will assess whether individual genes become mutated at relapsed in a recurrent fashion (in 2 or more patients in the cohort). |
Source ClinicalTrials.gov
Outcomes0
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.
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/NCT02757248
GET https://conductscience.org/api/trials/v1/NCT02757248/registered