Full Text View
Tabular View
No Study Results Posted
Related Studies
Study to Determine the Maximum Tolerated Dose of BIBW 2992 When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, August 2009
First Received: July 15, 2008   Last Updated: August 20, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00716417
  Purpose

Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU. The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.


Condition Intervention Phase
Neoplasms
Drug: BIBW 2992
Phase I

Study Type: Interventional
Study Design: Treatment, Safety Study
Official Title: A Phase Ib Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Continuous Dosing With BIBW 2992 Combined With Two Different Regimens of Backbone Chemotherapy: Cisplatin Combined With 5 Fluorouracil and Cisplatin Combined With Paclitaxel in Patients With Advanced Solid Tumors.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • To define MTD(A) and MTD(B) of BIBW 2992 when combined with cisplatin/paclitaxel (A) or cisplatin/5 FU (B) as assessed during the first cycle [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • Incidence and intensity of AEs associated with increasing doses of BIBW 2992 in combination with cisplatin with either paclitaxel or 5 FU. Pharmacokinetic and pharmacodynamic parameters of BIBW 2992 Objective response according RECIST [ Time Frame: from 1st treatment until EOT ]

Estimated Enrollment: 42
Study Start Date: July 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed diagnosis of non resectable and / or metastatic cancer, preferably squamous cell carcinomas of head and neck, oesophagus, lung or cervix
  2. Indication for a standard treatment with either cisplatin plus paclitaxel or cisplatin plus 5 FU as judged by the investigator
  3. Age 18 years or older.
  4. Life expectancy of at least three (3) months.
  5. Written informed consent that is consistent with ICH-GCP guidelines.
  6. Eastern Cooperative Oncology Group (ECOG) performance score less or equal 2.
  7. Patients must have recovered from any therapy-related toxicity from previous chemo-, hormone-, immuno-, or radiotherapies.
  8. Patients 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 diarrhoea.
  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 oedema 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 less than 50%
  6. Absolute neutrophil count (ANC) less than 1500 / mm3.
  7. Platelets count less than 100 000/mm3.
  8. Bilirubin more than 1.5 x upper limit of institutional norm.
  9. Aspartate amino transferase (AST) or alanine amino transferase (ALT) more than 3 x upper limit of institutional norm.
  10. Serum creatinine more than 1.5 x upper limit of institutional norm.
  11. Women and men 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, or radiotherapy or participation in another clinical study with anti-cancer therapy within the past 4 weeks before start of therapy or concomitantly with this study.
  14. Treatment with an EGFR- or HER2 inhibiting drug within the past four 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716417

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Belgium
1200.37.3202 Boehringer Ingelheim Investigational Site Recruiting
Bruxelles, Belgium
1200.37.3203 Boehringer Ingelheim Investigational Site Recruiting
Gent, Belgium
1200.37.3201 Boehringer Ingelheim Investigational Site Recruiting
Edegem, Belgium
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1200.37, EUDRACT2008 002613 43
Study First Received: July 15, 2008
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00716417     History of Changes
Health Authority: Belgium: Federal Agency for Medicines and Health Products

Study placed in the following topic categories:
Radiation-Sensitizing Agents
Cisplatin
Paclitaxel
Fluorouracil

Additional relevant MeSH terms:
Neoplasms
Radiation-Sensitizing Agents
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009