Phase 2
N=42
Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy
Urologic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02780687 ↗Enrolled (actual)
42
Serious AEs
50.0%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Progression-free Survival at Six Months (PFS6) in Cohort A — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Afatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Progression-free Survival at Six Months (PFS6) in Cohort A |
4 | — |
| SECONDARY Number of Participants With Confirmed Objective Response (ORR) in Cohort A |
2 | — |
| SECONDARY Progression-free Survival (PFS) in Cohort A |
9.8 | — |
| SECONDARY Overall Survival (OS) in Cohort A |
30.1 | — |
| SECONDARY Number of Participants With Disease Control (DCR) in Cohort A |
17; 17 | — |
| SECONDARY Duration of Disease Control in Cohort A |
22.7 | — |
| SECONDARY Number of Patients With Tumour Shrinkage in Cohort A |
9 | — |
Summary
The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors) mutations or ERBB2 amplifications (Cohort A), and EGFR (Epidermal Growth Factor Receptor) amplification positive tumours (Cohort B), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis.
The antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the trial. A key secondary endpoint will also be defined, the objective response rate (ORR).
Eligibility Criteria
Inclusion criteria
- Recurrent or metastatic urothelial cancer
- Patients must have failed prior platinum based treatment (adjuvant or 1st line)
- Archival tissue sample available for biomarker testing at pre-screening and tissue banking.
- Patients should complete a pre-screening biomarker analysis and should fulfill the following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should show EGFR (Epidermal Growth Factor Receptor) amplification.
- Further inclusion criteria apply
Exclusion criteria
- Prior use of EGFR, ERBB2 or ERBB3 targeted treatment
- Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
- Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02780687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.