Trial · NCT06594679
A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)
NCT06594679, Phase 1, Phase 2, Recruiting, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL). Trials, record NCT06594679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06594679
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)
- NCT number
- NCT06594679
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 73 participants, estimated
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Conditions
- Ovarian Cancer
- Interventions
- Niraparib Tosylate Monohydrate
- First posted
- 2024-09-19
- Last updated
- 2025-03-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | dose finding | 18 months | This is a dose-escalation study of niraparib plus abemaciclib followed by an efficacy study for late-line treatment of ovarian cancer |
| Primary | dose finding, phase Ib clinical trial | From enrollment to the end of phase 1 | Maximum tolerated dose (MTD) of niraparib in combination with abemaciclib in patients with advanced ovarian cancer defined as the dose level immediately below the dose at which ≥ 33% of patients experience dose-limiting toxicity as defined by protocol according to CTCAE 5.0 |
| Primary | PART II: Disease control rate at 16 weeks (DCR16wks): | From enrollment of first patient of part II to to the 16-week-radiologic assessment of last patient | proportion of patients whose disease shrinks (i.e. complete or partial response) or remains stable over 16 weeks after the start of niraparib + abemaciclib combination. Revised RECIST 1.1 criteria will be used to assess tumor response |
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/NCT06594679
GET https://conductscience.org/api/trials/v1/NCT06594679/registered