Study to Determine the Maximum Tolerated Dose of BIBW 2992 (Afatinib) When Combined With Cisplati… (NCT00716417) | Clinical Trial Compass
CompletedPhase 1
Study to Determine the Maximum Tolerated Dose of BIBW 2992 (Afatinib) When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours
Belgium47 participantsStarted 2008-07-01
Plain-language summary
Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU.
The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with histologically or cytologically confirmed diagnosis of non resectable and / or metastatic cancer, preferably squamous cell carcinomas of head and neck, oesophagus, lung or cervix
✓. Indication for a standard treatment with either cisplatin plus paclitaxel or cisplatin plus 5 FU as judged by the investigator
✓. Age 18 years or older.
✓. Life expectancy of at least three (3) months.
✓. Written informed consent that is consistent with ICH-GCP guidelines.
✓. Eastern Cooperative Oncology Group (ECOG) performance score less or equal 2.
✓. Patients must have recovered from any therapy-related toxicity from previous chemo-, hormone-, immuno-, or radiotherapies.
✓. Patients recovered from previous surgery.
Exclusion criteria
✕. Active infectious disease.
✕. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea.
✕. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
✕. 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 and no requirement for steroids or anti-epileptic therapy.
What they're measuring
1
Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
Timeframe: 21 days
2
Maximum Tolerated Dose (MTD) for Regimen A and Regimen B