Dose Escalation Study of Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumors

NCT02171637 | Completed Phase 1

• 1 other identifier: 1200.1
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation of maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBW 2992, pharmacodynamic modulation of biomarkers, correlation of Epidermal Growth Factor Receptor (EGFR) and Human EGF-like Receptor number 2 (HER2) immunohistochemical status with objective tumour responses

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  up to 28 months

• Incidence and intensity of Adverse Events (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) associated with increasing doses of BIBW 2992

  up to 28 months

Secondary Outcomes (15)

• Area under the plasma concentration-time curve (AUC) for different time points

  up to 384 hours after first drug administration

• Predose plasma concentration (Cpre) for different time points

  Day 8 and 14

• Minimum measured plasma concentration (Cmin) for different time points

  up to 384 hours after first drug administration

• Maximum measured plasma concentration (Cmax) for different time points

  up to 384 hours after first drug administration

• Time from dosing to the minimum plasma concentration (tmin) for different time points

  up to 384 hours after first drug administration

Study Arms (1)

BIBW 2992

EXPERIMENTAL

Drug: BIBW 2992

Interventions

BIBW 2992 DRUG

escalating doses

BIBW 2992

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumors, of types historically known to express EGFR and/or HER2, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
• Age 18 years or older
• Life expectancy of at least three (3) months
• Written informed consent given that is consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines
• Eastern Cooperative Oncology Group (ECOG) performance score 0, 1, or 2
• Patients must have resolution of prior chemo-, hormone, immuno-, or radiotherapy-related toxicities to CTC Grade \< 1
• Patients have to be recovered from previous surgery
• Paraffin-embedded tumor material must be accessible for analysis of EGFR and HER2-status.
• The additional 12 patients that were to be recruited at the MTD also had to fulfill the following criterion: Measurable tumor deposits (RECIST: Response Evaluation Criteria in Solid Tumors) by one or more techniques (X-ray, CT, MRI)

You may not qualify if:

• Active infectious disease
• Gastrointestinal disorders that might interfere with the absorption of the study drug or chronic diarrhea
• Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
• Brain metastases requiring therapy as based on clinical symptoms
• Impaired cardiac left ventricular function with resting ejection fraction CTC Grade ≥ 1
• Absolute neutrophil count (ANC) less than 1500 / mm3
• Platelet count less than 100 000 / mm3
• Bilirubin greater than 1.5 mg / dl (\> 26 μmol / L, SI unit equivalent)
• Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
• Serum creatinine greater than 1.5 mg / dl (\> 132 μmol / L, SI (Systeme International) unit equivalent)
• Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
• Pregnancy or breast-feeding
• Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (excluding LHRH agonists, other hormones taken for breast cancer, or bisphosphonates) or participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
• Patients unable to comply with the protocol
• Active alcohol or drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Afatinib

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: November 1, 2003
• Primary Completion: February 1, 2006
• Last Updated: June 24, 2014

Record last verified: 2014-06