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

Sponsor
Boehringer Ingelheim
Study ID
NCT00809133
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.
  • Carboplatin — DRUG
    AUC6 given on day 1 of 21 day cycle
  • BIBW 2992 — DRUG
    Escalating dose cohorts
  • Paclitaxel — DRUG
    Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.
  • BIBW2992 — DRUG
    MTD dose of part A
  • Paclitaxel — DRUG
    175mg/m2 given on Day 1 of 21 Day cycle
  • Carboplatin — DRUG
    AUC6 given on day 1 of 21 day cycle
  • Bevacizumab — DRUG
    Escalating dose Cohorts - 5mg / kg, 7.5mg / kg and 10mg / kg given Day 1 and Day 15 of a 28 days cycle
  • BIBW 2992 — DRUG
    Escalating dose cohorts
  • BIBW 2992 — DRUG
    Escalating dose cohorts

Study Details

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.

Key Dates

First listed
Dec 17, 2008
Start date
May 31, 2007
Status verified
Feb 2016
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

Enrollment
83 participants (actual)
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    BIBW2992 + Paclitaxel
  • Experimental: Part B
    BIBW2992 + Paclitaxel + Bevacizumab
  • Experimental: Part C
    BIBW2992 + Carboplatin
  • Experimental: Part D
    BIBW2992 +Paclitaxel + Carboplatin

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD) [ Time Frame: Cycle 1: 21 days (part C and D) or 28 days (part A and B) ]

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