Trial · NCT04893785
A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)
NCT04893785, Phase 2, Recruiting, National Cancer Institute, Naples
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM). Trials, record NCT04893785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04893785
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)
- NCT number
- NCT04893785
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 35 participants, estimated
- Lead sponsor
- National Cancer Institute, Naples
- Conditions
- Lung Neuroendocrine Neoplasm, GEP Neuroendocrine Tumor
- Interventions
- Cabozantinib and Temozolomide
- First posted
- 2021-05-20
- Last updated
- 2024-06-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the efficacy of the combination of cabozantinib and one-week-on/one-week-off temozolomide, based on overall response rate (ORR). | Up to 42 months | Overall Response Rate (ORR) (as assessed by RECIST v1.1) defined by complete response (CR) or partial response (PR). |
| Secondary | To assess the activity of the combination of cabozantinib and one-week-on one-week-off temozolomide according to Progression Free Survival (PFS) | Up to 42 months | PFS (as assessed by RECIST v1.1) defined as time from study entry to first evidence of disease progression or death due to any cause. |
| Secondary | To assess the activity of the combination of cabozantinib and one-week-on one-week-off temozolomide according to Clinical Benefit Rate (CBR) | Up to 42 months | CBR (as assessed by RECIST v1.1) defined by complete response (CR) or partial response (PR) or stable disease (SD). |
| Secondary | To assess the activity of the combination of cabozantinib and one-week-on one-week-off temozolomide according to Overall Survival (OS) | Up to 42 months | OS defined as time from study entry to death due to any cause or to study termination |
| Secondary | To assess the activity of the combination of cabozantinib and one-week-on one-week-off temozolomide according to duration of response (DOR) | Up to 42 months | DOR defined as time from study entry to change in response from CR or PR to Stable Disease (SD) or Progressive Disease (SD) (as assessed by RECIST v1.1). |
| Secondary | To assess the safety and tolerability of the combination of cabozantinib and one-week-on one-week-off temozolomide | Up to 42 months | Safety and tolerability as assessed by adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. After five patients, it will be perform a detailed safety report based on CTCAE v.5.0 |
| Secondary | To assess the predictive role of MGMT Methylation Status on response to the combination of cabozantinib and one-week-on one-week-off temozolomide | Up to 42 months | MGMT Methylation Status will be assessed and any correlation with the efficacy endpoints will be evaluated. |
| Secondary | To assess the activity of the combination of cabozantinib and one-week-on one-week-off temozolomide at 1 year from the start of the treatment | 1 year overall survival OS | 1 year overall survival OS |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41963331 | DERIVED |
Source PubMed
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/NCT04893785
GET https://conductscience.org/api/trials/v1/NCT04893785/registered