BIBW 2992 in Patients With Advanced Solid Tumors

NCT02171650 | Completed Phase 1

• 1 other identifier: 1200.17
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective was to collect safety data for BIBW 2992.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Adverse Events, according to Common Terminology Criteria (CTC) version 3, with particular scrutiny of events that were considered to be dose-limiting toxicities and those that were serious or significant

  up to 18 months

Secondary Outcomes (1)

• Durability of non-progression as measured by tumor assessment according to Response Evaluation Criteria in Solid Tumors (RECIST)

  every 8 weeks up to 18 months

Study Arms (1)

BIBW 2992

EXPERIMENTAL

Drug: BIBW 2992

Interventions

BIBW 2992 DRUG

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 who have completed the prescribed courses of the 1200.1 or 1200.2 studies without clinical disease progression
• 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 must be recovered from previous surgery

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, Systeme International (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 birth control
• 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 a clinical study other than 1200.1 or 1200.2
• Patients unable to comply with the protocol
• Active alcohol or drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Links

• Related Info

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: December 1, 2004
• Primary Completion: May 1, 2006
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share