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A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination With First Line Chemotherapy Regimens in Patients With Non-Small Cell Lung Cancer (NSCLC)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIB -IV

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Trial Information

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination With First Line Chemotherapy Regimens in Patients With Non-Small Cell Lung Cancer (NSCLC)


A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability,
Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in
Combination with First Line Chemotherapy Regimens in Patients with Non-Small Cell Lung
Cancer (NSCLC)


Inclusion Criteria:



- Provision of signed, written and dated consent prior to any study specific procedures

- Male or female, aged 18 years or older

- Histological or cytological confirmation of locally advanced or metastatic NSCLC
(IIIB-IV)

- Female patients must not be breast-feeding and have a negative pregnancy test prior
to start of dosing or must have evidence of non-child-bearing potential

- Patients must be eligible to receive treatment with the platinum doublet combination
with which selumetinib is being combined and in accordance with the local product
information

Exclusion Criteria:

- Prior chemotherapy or other systemic anti-cancer treatment for advanced NSCLC.

- Prior surgery or radiotherapy within 6 months or palliative radiotherapy within 4
weeks of start of study treatment.

- Female patients who are breast-feeding or male or female patients of reproductive
potential who are not employing an effective method of birth control

- Another primary malignancy within 5 years of starting study treatment, except for
adequately treated basal or squamous cell carcinoma of the skin or cancer of the
cervix in situ.

- As judged by the Investigator, any evidence of severe or uncontrolled systemic
diseases, active bleeding diatheses, renal transplant, or active infection

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Investigate safety, tolerability and recommended Phase II dose of selumetinib in combination with first line chemotherapy by assessing adverse events.

Outcome Time Frame:

Adverse events will be collected from consent until 28 days after the last dose of selumetinib, 180 days for the average patient

Safety Issue:

Yes

Principal Investigator

Ian Smith, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca UK, MSD

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D1532C00070

NCT ID:

NCT01809210

Start Date:

April 2013

Completion Date:

April 2014

Related Keywords:

  • Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIB -IV
  • MEK1/2 inhibitor,
  • Non Small Cell Lung Cancer,
  • metastatic,
  • first line treatment for Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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