Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV Clinical Trial

— SELECT-2  

Official title:

A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, Compared With Placebo in Combination With Docetaxel, in Patients Receiving Second Line Treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750281
• Other study ID #: D1532C00064
• Secondary ID: 2012-003622-25
• Status: Completed
• Phase: Phase 2
• Start date: December 18, 2012
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

Description:

A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, Compared with Placebo in Combination with Docetaxel, in Patients receiving second line treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: October 31, 2022
• Est. primary completion date: January 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• Provision of signed, written and dated informed 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)
• Prospective confirmation of KRAS mutation negative status as determined via an AZ approved laboratory
• Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy

Exclusion Criteria:

• Mixed small cell and non-small cell lung cancer histology
• Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
• Other concomitant anti-cancer therapy agents except steroids
• Prior treatment with a MEK (Mitogen-Activated Protein Kinase) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable)
• The last radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
• Lung Neoplasms

Intervention

Drug:
• Selumetinib 75 mg
Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.
• Docetaxel 75 mg/m2
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
• Docetaxel 60 mg/m2
Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
• Placebo
Three placebo capsules will be administered orally uninterrupted twice daily.

Locations

Country	Name	City	State
Brazil	Research Site	Barretos
Brazil	Research Site	Brasilia
Brazil	Research Site	Ijuí
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Santo André
Brazil	Research Site	São José do Rio Preto
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	São Paulo
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Bulgaria	Research Site	Vratza
France	Research Site	Brest Cedex
France	Research Site	Caen
France	Research Site	Clermont Ferrand
France	Research Site	Lille
France	Research Site	Pierre Benite Cedex
France	Research Site	Villejuif
Germany	Research Site	Essen
Germany	Research Site	Esslingen
Germany	Research Site	Großhansdorf
Germany	Research Site	Karlsruhe
Germany	Research Site	Löwenstein
Germany	Research Site	Moers
Germany	Research Site	Wiesbaden
Germany	Research Site	Würzburg
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Edelény
Hungary	Research Site	Gyor
Hungary	Research Site	Kaposvár
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyíregyháza
Hungary	Research Site	Székesfehérvár
Hungary	Research Site	Törökbálint
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Bergen Op Zoom
Netherlands	Research Site	Den Bosch
Netherlands	Research Site	Maastricht
Poland	Research Site	Gdansk
Poland	Research Site	Grudziadz
Poland	Research Site	Kraków
Poland	Research Site	Olsztyn
Poland	Research Site	Poznan
Poland	Research Site	Sucha Beskidzka
Poland	Research Site	Szczecin
United States	Research Site	Atlanta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Boston	Massachusetts
United States	Research Site	Chicago	Illinois
United States	Research Site	Hershey	Pennsylvania
United States	Research Site	Hollywood	Florida
United States	Research Site	Marrero	Louisiana
United States	Research Site	Mineola	New York
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Brazil,  Bulgaria,  France,  Germany,  Hungary,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): >= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.	Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)
Secondary	Overall Survival (OS)	The time from randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive	Following progression, survival status was collected every 8 weeks until death, withdrawal of consent, or end of study, whichever occurred first, up to 29 months (at the time of the analysis)

External Links

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