Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Approved-not yet active Over 18 Pharmaceutical / Industry 1200.26 NCT00748709

Trial Description

Summary

The primary objective of this trial is to estimate the objective response rate for patients with tumors harbouring EGFR and/or HER2 gene amplifications or EGFR activating mutations who will be treated with BIBW 2992.

Eligibility Criteria

Inclusion Criteria:

There are 2 Steps in the screening process:

Step 1 Inclusion criteria for pre-screening:

1. Histologically confirmed diagnosis of advanced cancer of one of the following four tumor type categories: Category 1, Gastric, GE junction, or Esophageal cancer Category 2, Biliary or gallbladder cancer Category 3, TCC bladder cancer, and Category 4, Gynecological cancers

2. Measurable disease by RECIST criteria.

3. Willingness and ability to give written informed consents consistent with ICHGCP guidelines.

4. Life expectancy of at least six (6) months.

5. Eastern Cooperative Oncology Group performance score 0, 1 or 2.

6. Age >18 years.

Step 2 Inclusion criteria for enrollment:

Patients who have tested positive for FISH and are considered candidate for this trial must meet all of the following inclusion criteria:

1. Histologically confirmed diagnosis of advanced cancer of one of the following four tumor type categories: Category 1, Gastric, GE junction, or Esophageal cancer Category 2, Biliary or gallbladder cancer Category 3, TCC bladder cancer, and Category 4, Gynecological cancers

2. Documented failure to respond or progression of underlying cancer after at least one line of prior chemotherapy.

3. EGFR and/or HER2 gene amplification by FISH testing or patients with tumors that harbor known activating EGFR mutations.

4. Measurable disease by RECIST criteria.

5. Willingness and ability to give written informed consents consistent with ICH-GCP guidelines.

6. Life expectancy of at least six (6) months.

7. Eastern Cooperative Oncology Group performance score 0, 1 or 2.

8. Age >18 years.

Exclusion Criteria:

1. Prior treatment with gefitinib, erlotinib, lapatinib and/or other EGFR TKIs.

2. Treatment with cytotoxic anti-cancer-therapies or investigational drugs during the last four weeks prior to the first treatment with the trial drug. (a shorter duration may be considered for patients treated with oral, non cytotoxic drugs on an individual basis and upon discussion between the principal investigator and sponsor)

3. Inability to take BIBW 2992 by mouth (BIBW 2992 may not be crushed or administered via feeding tube)

4. Chronic diarrhea or other gastrointestinal disorders that may interfere with the absorption of the trial drug.

5. History of other malignancies unless free of disease for at least 3 years (except for appropriately treated superficial non-melanoma skin cancer and surgically cured cervical cancer in situ).

6. History of congestive heart failure

7. Resting left ventricular ejection fraction <50% OR below the institution's lower limit of normal (if the institutions lower limit is above 50%), measured by MUGA scan or echocardiogram.

8. Active infectious disease

9. Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with participation in this trial.

10. Active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal brain MRI scan at screening and be at least three months post-radiation or surgery for brain metastasis.

11. Absolute Neutrophil Count (ANC) less than 1,000/mm3.

12. Platelet count less than 100,000/mm3.

13. Hemoglobin Level less than 9.0 grams/dl.

Trial Contact Information

Trial Lead Organizations/Sponsors

Boehringer Ingelheim Pharmaceuticals, Incorporated - Ridgefield

Boehringer Ingelheim

Study Chair

Boehringer Ingelheim Study Coordinator
		Email: clintriage.rdg@boehringer-ingelheim.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00748709
Information obtained from ClinicalTrials.gov on September 09, 2008