Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2

Sponsor
Boehringer Ingelheim
Study ID
NCT00906698
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • BIBW 2992 low (20mg) dosage — DRUG
    Patients will receive 20mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.
  • BIBW 2992 medium (40mg) dosage — DRUG
    Patients will receive 40mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.
  • BIBW 2992 high (50mg) dosage — DRUG
    Patients will receive 50mg dosage of BIBW 2992 plus standard dosage of vinorelbine.
  • Vinorelbine per os 60 mg/m² — DRUG
    Patients will receive 60 mg/m² Vinorelbine per os at J1 J8 and J15
  • Vinorelbine per os 80 mg/m² — DRUG
    Patients will receive 80 mg/m² Vinorelbine per os at J22
  • Vinorelbine i.v. 25 mg/m² — DRUG
    Patients will receive 25 mg/m² of Vinorelbine i.v.

Study Details

To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine

Key Dates

Start date
Jun 30, 2009
Status verified
Mar 2014
Primary completion
Jan 31, 2013
Completion
Jan 31, 2013

Study Design

Enrollment
55 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BIBW 2992 and vinorelbine i.v
    Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine i.v.
  • Experimental: BIBW 2992 and vinorelbine per os
    Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine per os.

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicities (DLT) [ Time Frame: 28 days ]

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