Trial Exploring Afatinib (BIBW 2992) + Paclitaxel (Part A), Afatinib + Paclitaxel + Bevacizumab (Part B), Afatinib + Carboplatin (Part C) and Afatinib+ Paclitaxel +Carboplatin(Part D) in Patients With Advanced Solid Tumours
United Kingdom83 participantsStarted 2007-05
Plain-language summary
The main purpose of this study is to assess the optimum dose of the following medications when they are given together:
* BIBW 2992 and paclitaxel (Taxol)
* BIBW 2992 and paclitaxel and bevacizumab (Avastin)
* BIBW 2992 and carboplatin
* BIBW 2992 and paclitaxel and carboplatin The effect of the different drug combinations will also be assessed.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients (patients) with a histologically confirmed diagnosis of malignancy that is now advanced, non-resectable and / or metastatic.
✓. Age 18 years old or older.
✓. 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 or 1.
✓. Patients must have recovered from any previous surgery.
✓. Adequate organ function including the following:
✓. Cardiac left ventricular function with resting ejection fraction greater than or equal to 50%
Exclusion criteria
✕. Active infectious disease
✕. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
✕. GI tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
✕. Significant cardiovascular disease (a history of congestive heart failure requiring therapy, a need for anti-arrhythmic therapy for a ventricular arrhythmia, unstable angina pectoris or myocardial infarction within 6 months prior to trial entry).
What they're measuring
1
Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
Timeframe: Cycle 1: 21 days (part C and D) or 28 days (part A and B)
2
Maximum Tolerated Dose (MTD)
Timeframe: Cycle 1: 21 days (part C and D) or 28 days (part A and B)
✕. Patients who require full-dose anticoagulation.
✕. Patients not completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade 1. Prior chemotherapy is allowed if completed at least 4 weeks prior to 1st trial treatment (6 weeks for mitomycin C or nitrosoureas) and the patient has recovered from the acute toxicities of that therapy.
✕. 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 8 weeks, no history of cerebral oedema or bleeding in the past 8 weeks and no requirement for steroids or anti-epileptic therapy
✕. Persistent Grade 2 or greater neurotoxicity / neuropathy from any cause.