Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer (SELECT-3)

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Locally Advanced or Metastatic NSCL Cancer Stage IIIB IV

Treatments

Drug: gemcitabine

Drug: selumetinib

Drug: cisplatin

Drug: pemetrexed

Drug: carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01809210

EudraCT number: 2012-005202-22

D1532C00070

Details and patient eligibility

About

This is a Phase I, open label multicentre study of selumetinib administered orally in combination with first line chemotherapy regimens to patients with advanced/metastatic NSCLC. The study has been designed to allow an investigation of the optimal dose of selumetinib in combination with various standard first line double-platinum chemotherapy regimens. Initial assessment will be based on tolerability of selumetinib in combination with one or more selected regimens that are considered to be tolerated also being assessed for preliminary evidence of activity.

This study is a dose finding and optional cohort expansion; In addition all patients will be assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.

Full description

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)

Enrollment

55 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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