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

NCT02171702 | Completed Phase 1

• 1 other identifier: 1200.3
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study was to identify the maximum tolerated dose and to evaluate safety, pharmacokinetics, pharmacodynamic parameters, and efficacy of BIBW 2992.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) of BIBW 2992

  up to 24 weeks

• Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 3) associated with increasing doses of BIBW 2992

  up to 28 weeks

Secondary Outcomes (15)

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

  up to 648 hours after first drug administration, pre-dose on day 15 and 28

• Percentage of AUC0-∞ that is obtained by extrapolation (%AUCtz-∞)

  up to 648 hours after first drug administration, pre-dose on day 15 and 28

• predose plasma concentration

  predose on days 8, 15, 22 and 27

• Plasma concentration

  24 hours after drug administration on the first (C24,1) and the Day 27 dose (C24,27)

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

  up to 648 hours after first drug administration, pre-dose on day 15 and 28

Study Arms (3)

BIBW 2992

EXPERIMENTAL

dose escalation

Drug: BIBW 2992

BIBW 2992, fasted

EXPERIMENTAL

food effect part: maximum tolerated dose of BIBW 2992

Drug: BIBW 2992

BIBW 2992, fed

EXPERIMENTAL

food effect part: maximum tolerated dose of BIBW 2992

Drug: BIBW 2992

Interventions

BIBW 2992 DRUG

BIBW 2992; BIBW 2992, fasted; BIBW 2992, fed

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 tumours, 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 preferably patients with breast, colorectal or prostate cancer
• Age 18 years or older
• Life expectancy of at least three (3) months
• Written informed consent that is consistent with International Conference on Harmonization - Good Clinical Practice guidelines
• Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2
• Patients completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC \<= Grade 1
• Patients must be recovered from previous surgery
• The 12 additional patients recruited at the MTD must also meet the following criteria:
• Measurable tumour deposits (RECIST) by one or more techniques (X-ray, CT, MRI) and/or recognized tumour markers such as prostate-specific antigen prostate cancer) or cancer antigen 125 (Ovarian cancer)

You may not qualify if:

• Active infectious disease
• Gastrointestinal disorders that may 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
• 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 eight (8) weeks, no history of cerebral edema or bleeding in the past eight (8) weeks and no requirement for steroids or anti-epileptic therapy
• 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, Système Internationale (SI) unit equivalent)
• Aspartate amino transferase (AST) 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 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 Luteinizing Hormone-Releasing Hormone agonists, or other hormones taken for breast cancer, or bisphosphonates), or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study
• Treatment with an EGFR- or HER2 inhibiting drug within the past four weeks before start of therapy or concomitantly with this study (8 weeks for trastuzumab)
• Patients unable to comply with the protocol

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: RANDOMIZED
• 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, 2004
• Primary Completion: March 1, 2007
• Last Updated: June 24, 2014

Record last verified: 2014-06