BIBW 2992 After Administration of Docetaxel in Patients With Advanced Solid Tumors

NCT02171676 | Completed Phase 1

• 1 other identifier: 1200.20
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Maximum tolerated dose (MTD), safety, pharmacokinetic and pharmacodynamic parameters, and efficacy of pulsatile administration of BIBW 2992 in combination with docetaxel (Taxotere®)

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  up to 168 days

• Incidence and intensity of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE version 3.0)

  up to 35 months

Secondary Outcomes (15)

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

  up to 48 hours after the first drug administration

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

  up to 48 hours after the first drug administration

• Pre-dose plasma concentration (Cpre)

  pre-dose on day 3 and 4

• Plasma concentration at 24 h following the first (C24,1) dose

  24 hours after the first drug administration

• Maximum measured plasma concentration (Cmax)

  up to 48 hours after the first drug administration

Study Arms (1)

Docetaxel + BIBW 2992

EXPERIMENTAL

Dose escalation

Drug: Docetaxel; Drug: BIBW 2992

Interventions

Docetaxel DRUG

Also known as: Taxotere

Docetaxel + BIBW 2992

BIBW 2992 DRUG

Docetaxel + 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 preferably patients with breast, prostate, or ovarian cancer. In addition, patients with a disease amenable for standard treatment with docetaxel
• 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 or 1
• Patients recovered (Common Terminology Criteria (CTC) Grade 0 or 1) from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies
• Patients recovered from previous surgery
• The 12 additional patients recruited at the MTD must also meet the following criteria:
• Measurable tumor deposits (Response Evaluation Criteria in Solid Tumors) by one or more techniques (X-ray, CT, MRI) and/or recognized tumor 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 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
• 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 weeks, no history of cerebral edema or bleeding in the past eight 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 \> upper limit of normal (ULN)
• Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) \> 1.5 x ULN
• Alkaline Phosphatase \> 2.5 x ULN
• Serum creatinine \> 1.5 mg / dl (\> 132 μmol / L, SI (Système Internationale) unit equivalent)
• Women and men 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 luteinising hormone-releasing hormone 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
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Docetaxel; Afatinib

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Amides; 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: May 1, 2005
• Primary Completion: March 1, 2008
• Last Updated: June 24, 2014

Record last verified: 2014-06