Afatinib (BIBW 2992) QTcF Trial in Patients With Relapsed or Refractory Solid Tumours (NCT00875433) | Clinical Trial Compass
CompletedPhase 2
Afatinib (BIBW 2992) QTcF Trial in Patients With Relapsed or Refractory Solid Tumours
United Kingdom60 participantsStarted 2009-03
Plain-language summary
A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the effectiveness of afatinib (BIBW 2992) in treating certain cancers. Cancers studied will include glioblastoma and cancers which have spread to the brain (metastases).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged at least 18 years old.
✓. Histologically or cytologically confirmed diagnosis of a solid malignant tumour, known to express EGFR/HER2 that is either refractory to standard therapies, or for which no standard treatment is available (including patients with brain metastases).
✓. At least one tumor lesion that can accurately be measured by computed tomography (CT) or magnetic resonance imaging (MRI) in at least one dimension with longest diameter to be recorded as greater than or equal to 20 mm using conventional techniques or greater than or equal to 10 mm with spiral CT scan.
✓. Life expectancy of at least 3 months.
✓. Written informed consent that is consistent with ICH-GCP guidelines.
✓. Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2.
✓. Patients must have recovered from any previous surgery.
✓. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of trial participation. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of trial enrolment. Breast feeding mothers will be excluded since these agents may be toxic to infants.
Exclusion criteria
✕. Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least four (4) weeks, no history of cerebral oedema or bleeding in the past four (4) weeks. Steroids will be allowed. Anti-epileptic therapy will be allowed if no changes are anticipated within the initial 14 days of treatment (QTC-evaluation).
What they're measuring
1
Objective Response (OR)
Timeframe: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
2
Average Time-matched QT Corrected by the Fridericia Formula (QTcF) Change From Baseline to Day 14
Timeframe: The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.
✕. Less than 4 weeks between radiotherapy and start of study treatment, unless new enhancing lesion outside of radiation field or radiologically progressive on two consecutive MRI scans at least four weeks apart or biopsy-proven recurrence.
✕. Less than two weeks from surgical resection (one week from prior stereotactic biopsy) or major surgical procedure.
✕. Less than two weeks after previous chemotherapy (6 weeks from nitrosureas).
✕. Less than four weeks from prior treatment with bevacizumab.
✕. Treatment with other investigational drugs; participation in another clinical study within the past 2 weeks before start of therapy or concomitantly with this study.