Dose Escalation Trial of BIBW 2992 Administration in Combination With Docetaxel in Patients With Advanced Solid Tumors

NCT02171741 | Completed Phase 1

• 1 other identifier: 1200.6
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to determine the maximum tolerated dose (MTD) for various treatment durations of BIBW 2992 when administered in combination with docetaxel as determined by drug-related adverse events (AEs) as well as Pharmacokinetics, overall safety and antitumor efficacy.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Incidence and intensity of AdverseEvents according to Common Terminology Criteria (CTCAE version 3)

  up to 32 months

• Maximum tolerated dose (MTD) of BIBW 2992

  up to 126 days

Secondary Outcomes (14)

• Objective tumor response

  up to 32 months

• Correlation of EGFR (epidermal growth factor receptor), HER2, estrogen receptor (ER) and progesterone receptor (PrR) immunohistochemical status as based on tumor biopsies, or excisions obtained prior to this trial, with objective tumor responses

  up to 32 months

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

  up to 48 hours after administration

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

  up to 48 hours after administration

• Predose plasma concentration (Cpre) for several time points

  predose on day 10 and 21

Study Arms (1)

Docetaxel + BIBW 2992

EXPERIMENTAL

Drug: BIBW 2992; Drug: Docetaxel

Interventions

BIBW 2992 DRUG

continuous daily dosing for 20 or 13 days

Docetaxel + BIBW 2992

Docetaxel DRUG

single infusion on day 1

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 are amenable to docetaxel, preferably patients with breast, prostate, or non-small cell lung cancer. Patients must have failed prior standard therapies associated with clinical benefits, including survival benefits, if such therapies are available. If docetaxel administration is standard therapy associated with clinical benefits, patients are eligible
• 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 must have resolution from prior chemo-, hormone-, immuno-, or radiotherapy related toxicities to CTC Grade \<= 1or baseline for individual patient
• 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 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 who are sexually active and unwilling to use a medically acceptable method of contraception
• Pregnancy or breast-feeding
• Concurrent treatment with other investigational drugs, or 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 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

Afatinib; Docetaxel

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

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: April 1, 2005
• Primary Completion: December 1, 2007
• Last Updated: June 24, 2014

Record last verified: 2014-06