Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-09-30

Brief Summary

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The primary objective of this trial is to identify the Maximum Tolerated Dose of BIBW 2992 therapy when given continuously in combination with Sirolimus.

The MTD will be based on the Dose Limiting Toxicity information collected during the first two cycles.

Overall safety, pharmacokinetics and anti-tumour efficacy will be evaluated as secondary objectives.

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Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIBW 2992 + Sirolimus

Dose escalation of the combination BIBW 2992 plus Sirolimus.

Group Type EXPERIMENTAL

BIBW 2992

Intervention Type DRUG

Dose escalation (19-40 patients): low or high dose oral + 12 addit. pat. at MTD, until progression or undue AEs

Sirolimus (rapamycin)

Intervention Type DRUG

Dose escalation (19-40 patients): several dose levels + 12 addit. pat. at MTD until progression or undue AEs.

Interventions

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BIBW 2992

Dose escalation (19-40 patients): low or high dose oral + 12 addit. pat. at MTD, until progression or undue AEs

Intervention Type DRUG

Sirolimus (rapamycin)

Dose escalation (19-40 patients): several dose levels + 12 addit. pat. at MTD until progression or undue AEs.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Pathologically or cytologically confirmed diagnosis of Stage IIIB or Stage IV NSCLC
2. Patients who have failed conventional treatment (at least 1 prior treatment line), or for whom no therapy of proven efficacy exists
3. Patients whose tumors:

* are EGFR mutation-positive or
* are EGFR mutation-negative or unknown provided they had disease progression after achieving either response or stable disease for at least 6 months from a previous treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
4. Patients aged 18 years or older
5. Life expectancy of at least three (3) months
6. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0-2
7. Written informed consent that is consistent with ICH-GCP guidelines

Exclusion Criteria

1. Prior major surgery, chemotherapy or radiation therapy within 4 weeks before start of therapy.
2. Prior treatment with an mTOR inhibitor within the past 4 weeks before start of therapy or concomitantly with this study
3. Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of run-in treatment with Sirolimus
4. Active CNS metastases (defined as stable for \<4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids)
5. Severe alteration in serum fasting cholesterol (equal or more than 350 mg/dL) or triglycerides (equal or more than 400 mg/dL). Patients may be allowed to enrol on the trial after initiation of lipid lowering agents.
6. Requirement for treatment with any of the prohibited concomitant medications:

* Concomitant CYP3A4 inhibitors within the past 7 days before start of therapy or concomitantly with this study.
* Concomitant CYP3A4 inducers within the past 14 days before start of therapy or concomitantly with this study.
7. Any contraindications for therapy with Sirolimus.
8. Known hypersensitivity to BIBW 2992, Sirolimus or other rapamycin analogues (everolimus, temsirolimus, deforolimus, etc.) or the excipients of any of the trial drugs.
9. Use of any investigational drug within 4 weeks before start of therapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No