Trial Exploring Afatinib (BIBW 2992) + Paclitaxel (Part A), Afatinib + Paclitaxel + Bevacizumab (Part B), Afatinib + Carboplatin (Part C) and Afatinib+ Paclitaxel +Carboplatin(Part D) in Patients With Advanced Solid Tumours

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2015-02-28

Brief Summary

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The main purpose of this study is to assess the optimum dose of the following medications when they are given together:

* BIBW 2992 and paclitaxel (Taxol)
* BIBW 2992 and paclitaxel and bevacizumab (Avastin)
* BIBW 2992 and carboplatin
* BIBW 2992 and paclitaxel and carboplatin The effect of the different drug combinations will also be assessed.

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A

BIBW2992 + Paclitaxel

Group Type EXPERIMENTAL

BIBW 2992

Intervention Type DRUG

Escalating dose cohorts

Paclitaxel

Intervention Type DRUG

Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.

Part B

BIBW2992 + Paclitaxel + Bevacizumab

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.

BIBW2992

Intervention Type DRUG

MTD dose of part A

Bevacizumab

Intervention Type DRUG

Escalating dose Cohorts - 5mg / kg, 7.5mg / kg and 10mg / kg given Day 1 and Day 15 of a 28 days cycle

Part C

BIBW2992 + Carboplatin

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

AUC6 given on day 1 of 21 day cycle

BIBW 2992

Intervention Type DRUG

Escalating dose cohorts

Part D

BIBW2992 +Paclitaxel + Carboplatin

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

AUC6 given on day 1 of 21 day cycle

Paclitaxel

Intervention Type DRUG

175mg/m2 given on Day 1 of 21 Day cycle

BIBW 2992

Intervention Type DRUG

Escalating dose cohorts

Interventions

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Paclitaxel

Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.

Intervention Type DRUG

Carboplatin

AUC6 given on day 1 of 21 day cycle

Intervention Type DRUG

BIBW 2992

Escalating dose cohorts

Intervention Type DRUG

Paclitaxel

Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.

Intervention Type DRUG

BIBW2992

MTD dose of part A

Intervention Type DRUG

Paclitaxel

175mg/m2 given on Day 1 of 21 Day cycle

Intervention Type DRUG

Carboplatin

AUC6 given on day 1 of 21 day cycle

Intervention Type DRUG

Bevacizumab

Escalating dose Cohorts - 5mg / kg, 7.5mg / kg and 10mg / kg given Day 1 and Day 15 of a 28 days cycle

Intervention Type DRUG

BIBW 2992

Escalating dose cohorts

Intervention Type DRUG

BIBW 2992

Escalating dose cohorts

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients (patients) with a histologically confirmed diagnosis of malignancy that is now advanced, non-resectable and / or metastatic.
2. Age 18 years old or older.
3. Life expectancy of at least 3 months.
4. Written informed consent that is consistent with ICH-GCP guidelines.
5. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
6. Patients must have recovered from any previous surgery.
7. Adequate organ function including the following:
8. Cardiac left ventricular function with resting ejection fraction greater than or equal to 50%
9. Absolute neutrophil count of greater than or equal to 1,500/microlitres; greater than 2000/microlitres for carboplatin
10. Platelets greater than or equal to 100,000/microlitres
11. Total bilirubin less than or equal to 1.5 mg/dl (\<26 micromol /L, SI unit equivalent).
12. AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal.
13. Creatinine less than or equal to 1.5 mg/dl (less than or equal to 132 micromol per liter, SI unit equivalent).
14. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of trial participation. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of trial enrolment. Breast feeding mothers will be excluded since these agents may be toxic to infants.

Exclusion Criteria

1. Active infectious disease
2. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
3. GI tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
4. Significant cardiovascular disease (a history of congestive heart failure requiring therapy, a need for anti-arrhythmic therapy for a ventricular arrhythmia, unstable angina pectoris or myocardial infarction within 6 months prior to trial entry).
5. Patients who require full-dose anticoagulation.
6. Patients not completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade 1. Prior chemotherapy is allowed if completed at least 4 weeks prior to 1st trial treatment (6 weeks for mitomycin C or nitrosoureas) and the patient has recovered from the acute toxicities of that therapy.
7. 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 8 weeks, no history of cerebral oedema or bleeding in the past 8 weeks and no requirement for steroids or anti-epileptic therapy
8. Persistent Grade 2 or greater neurotoxicity / neuropathy from any cause.
9. Patients on immunosuppressant therapy or with known HIV infection.
10. Treatment with any of the following within 4 weeks of starting trial medication, or during the trial, is not permitted: chemo-, immuno-, radio- (small field palliative radiotherapy is allowed provided this does not represent clear disease progression), biological therapies (including trastuzumab), hormone therapy (excluding LHRH agonists in prostate cancer, or bisphosphonates), or treatment with other investigational drugs.
11. Participation in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial.
12. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past 4 weeks before start of therapy or concomitantly with this trial.
13. Patients with known or suspected hypersensitivity to any of the trial drugs, their excipients or similar compounds.
14. Patients unable to comply with the protocol.
15. Active alcohol or drug abuse.
16. Patients with known pre-existing interstitial lung disease

17. Patients with known or suspected hypersensitivity to bevacizumab, its excipients or Chinese hamster ovary cell products or other recombinant human or humanised antibodies.
18. Patients with brain metastases (a brain scan is not required unless the patient shows signs and symptoms of brain metastases and a brain scan is performed to rule out the presence of brain metastases).
19. Patients with intra-abdominal inflammation .
20. Major surgery within 4 weeks of starting treatment or any wound(s) deemed by the investigator to pose a significant risk to the patient in the event of delayed healing.
21. Prior treatment with anthracycline and/or prior radiation to the chest wall ( patients in these categories will only be entered into the study where the investigator deems the benefit to the patient to outweigh the risk).

* Patients with severe myelosuppression; i.e. absolute neutrophil count less than 2000/microlitres
* Patients with renal impairment (creatinine clearance less than 60ml per minute by Cockcroft-Gault equation)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No