Trial · NCT03083678
Afatinib in Locally Advanced and Metastatic Chordoma
NCT03083678, Phase 2, Completed, Leiden University Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Afatinib in Locally Advanced and Metastatic Chordoma. Trials, record NCT03083678. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03083678
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Afatinib in Locally Advanced and Metastatic Chordoma
- NCT number
- NCT03083678
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Leiden University Medical Center
- Conditions
- Chordoma
- Interventions
- Afatinib
- First posted
- 2017-03-20
- Last updated
- 2025-02-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median PFS according to RECIST 1.1 criteria on afatinib treatment (first-line cohort) | From date of start treatment until date of first documented of progression or withdrawal (through study completion, an average of 1 year). | The objective is to increase the median PFS ≥ 12 months in first-line treatment cohort. |
| Primary | Median PFS according to RECIST 1.1 criteria on afatinib treatment (second or later line cohort) | From date of start treatment until date of first documented of progression or withdrawal (through study completion, an average of 1 year). | The objective is to increase the median PFS ≥ 9 months in later-line treatment cohort. |
| Primary | Quality of life assessment by EORTC QLC-30 questionnaire. | From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year). | Change from baseline in EORTC QLC-30 questionnaire score. |
| Primary | Quality of life assessment by Brief pain inventory short form | From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year). | Change from baseline on Brief pain inventory short form score. |
| Secondary | Growth modulation index. | From date of start treatment until date of first documented of progression (through study completion, an average of 1 year). | Time to progression during afatinib treatment (TTP2) divided by time to progression before start of this treatment TTP1 (= growth modulation index) |
| Secondary | Toxicity determined by CTCAE v 4.03 criteria | From date of start treatment until date of first documented of progression or withdrawal (through study completion, an average of 1 year). | Toxicity determined by CTCAE v 4.03 criteria |
| Secondary | Overall survival. | Survival follow-up after end of treatment every 3 months for up to 2 years followed by contact at 3 years. | Overall survival from start of afatinib treatment |
| Other | Translational research - EGFR pathway analysis in tumor tissue | From date of inclusion until date of first documented of progression or withdrawal (through study completion, an average of 1 year) | EGFR status by FISH / immunohistochemistry |
| Other | Translational research - Genome sequence analysis of available tumor samples | From date of inclusion until date of first documented of progression or withdrawal (through study completion, an average of 1 year) | Genetic mutations by DNA whole genome sequencing of fresh samples |
| Other | Translational research - circulating tumor DNA | Analysis on blood samples to be taken at baseline, cycle 4 day 1, cycle 7 day 1 and at end of treatment (within 30 days after last dose of study drug). | Circulating chordoma tumor DNA identification by WGS and PCR |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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/NCT03083678
GET https://conductscience.org/api/trials/v1/NCT03083678/registered