Phase I of BIBW 2992/BIBF 1120 Combination Therapy in Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00730821
First received: August 5, 2008
Last updated: August 20, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Neoplasms
Drug: BIBW 2992
Drug: BIBF 1120
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Combination Phase I Open Label Dose Escalation Study of Concomitant Administration of BIBW 2992 With BIBF 1120 in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • Pharmacokinetics, Objective tumor response. [ Time Frame: Until undue toxicity or progressive disease. ]

Enrollment: 28
Study Start Date: January 2007
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: BIBW 2992 Drug: BIBF 1120

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Age 18 years or older.
  3. Life expectancy of at least three (3) months.
  4. Written informed consent that is consistent with ICH-GCP guidelines.
  5. Eastern Cooperative Oncology Group performance score 0, 1or 2.
  6. Patients recovered from any therapy-related toxicities from previous chemo-,hormone-, immuno-, or radiotherapies to CTC <= Grade 1.
  7. Patients must have recovered from previous surgery.

Exclusion Criteria:

  1. Active infectious disease.
  2. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
  3. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
  4. 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.
  5. Cardiac left ventricular function with resting ejection fraction <50%.
  6. Absolute neutrophil count (ANC) less than 1500/mm3.
  7. Platelet count less than 100,000/mm3.
  8. Bilirubin greater than 1.5 mg/dl (>26 ¿mol /L, SI unit equivalent).
  9. 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 ).
  10. Serum creatinine greater than 1.5 mg/dl (>132 ¿mol/L, SI unit equivalent).
  11. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception.
  12. Pregnancy or breast-feeding.
  13. 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.
  14. 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).
  15. Patients unable to comply with the protocol.
  16. Active alcohol or drug abuse.
  17. Patients who require therapeutic anticoagulation or antiplatelet therapy [except treatment with Aspirin (Acetylsalicylic Acid)].
  18. Patients with history of haemorrhagic or thrombotic events (including transient ischemic attacks) in the past 12 months. Known inherited predisposition to bleeding or thrombosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730821

Locations
United States, Arizona
1239.1.3 Boehringer Ingelheim Investigational Site
Scottsdale, Arizona, United States
United States, Florida
1239.1.1 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Michigan
1239.1.2 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
United States, Nebraska
1239.1.4 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00730821     History of Changes
Other Study ID Numbers: 1239.1
Study First Received: August 5, 2008
Last Updated: August 20, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nintedanib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014