- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00730821
Phase I of BIBW 2992/BIBF 1120 Combination Therapy in Solid Tumors
A Combination Phase I Open Label Dose Escalation Study of Concomitant Administration of BIBW 2992 With BIBF 1120 in Patients With Advanced Solid Tumors
The primary objective of this trial is to determine the MTD of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly in a 28-day cycle schedule.
Secondary objectives are the collection of antitumor efficacy data, the determination of pharmacokinetic parameters of BIBF 1120 and BIBW 2992, and if data allow the determination of the pharmacokinetic influence of BIBW 2992 on BIBF 1120 and vice versa.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Arizona
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Scottsdale, Arizona, United States
- 1239.1.3 Boehringer Ingelheim Investigational Site
-
-
Florida
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Tampa, Florida, United States
- 1239.1.1 Boehringer Ingelheim Investigational Site
-
-
Michigan
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Detroit, Michigan, United States
- 1239.1.2 Boehringer Ingelheim Investigational Site
-
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Nebraska
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Omaha, Nebraska, United States
- 1239.1.4 Boehringer Ingelheim Investigational Site
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid tumors, 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 that is consistent with ICH-GCP guidelines.
- Eastern Cooperative Oncology Group performance score 0, 1or 2.
- Patients recovered from any therapy-related toxicities from previous chemo-,hormone-, immuno-, or radiotherapies to CTC <= Grade 1.
- Patients must have recovered from previous surgery.
Exclusion Criteria:
- 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 four (4) weeks, no history of cerebral edema or bleeding in the past four (4) weeks and no requirement for steroids or anti-epileptic therapy.
- Cardiac left ventricular function with resting ejection fraction <50%.
- Absolute neutrophil count (ANC) less than 1500/mm3.
- Platelet count less than 100,000/mm3.
- Bilirubin greater than 1.5 mg/dl (>26 ¿mol /L, SI unit equivalent).
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than two and a half times the upper limit of normal (2.5 X ULN ).
- Serum creatinine greater than 1.5 mg/dl (>132 ¿mol/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 (including LHRH agonists, megestrol acetate, or other hormones taken for breast cancer or prostate cancer); participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. Treatment with bisphosphonates is allowed.
- Treatment with an EGFR- or HER2 inhibiting drug within the past 4 weeks before start of therapy or concomitantly with this study (2 weeks for trastuzumab).
- Patients unable to comply with the protocol.
- Active alcohol or drug abuse.
- Patients who require therapeutic anticoagulation or antiplatelet therapy [except treatment with Aspirin (Acetylsalicylic Acid)].
- Patients with history of haemorrhagic or thrombotic events (including transient ischemic attacks) in the past 12 months. Known inherited predisposition to bleeding or thrombosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint of this trial is the safety of the combination of BIBW 2992/BIBF 1120 when administered concomitantly, and this is assessed by the dose limiting toxicity
Time Frame: Until undue toxicity or progressive disease.
|
Until undue toxicity or progressive disease.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics, Objective tumor response.
Time Frame: Until undue toxicity or progressive disease.
|
Until undue toxicity or progressive disease.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1239.1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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