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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01933932




Registration number
NCT01933932
Ethics application status
Date submitted
29/08/2013
Date registered
2/09/2013
Date last updated
24/05/2024

Titles & IDs
Public title
Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
Scientific title
A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1)
Secondary ID [1] 0 0
2013-001676-38
Secondary ID [2] 0 0
D1532C00079
Universal Trial Number (UTN)
Trial acronym
SELECT-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Selumetinib
Treatment: Drugs - Docetaxel
Treatment: Drugs - Placebo
Treatment: Drugs - Pegylated G-CSF

Experimental: Selumetinib + Docetaxel - Three 25mg Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle

Experimental: Placebo + Docetaxel - Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.


Treatment: Drugs: Selumetinib
Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.

Treatment: Drugs: Docetaxel
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

Treatment: Drugs: Placebo
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.

Treatment: Drugs: Pegylated G-CSF
All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Secondary outcome [4] 0 0
Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Timepoint [4] 0 0
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
Secondary outcome [5] 0 0
Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Timepoint [5] 0 0
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)

Eligibility
Key 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)

- KRAS mutation positive tumour sample as determined by the designated testing
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
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

- Receiving or have received systemic anti-cancer therapy within 30 days prior to
starting study treatment

- Other concomitant anti-cancer therapy agents excepts steroids

- Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any
docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).

- Last radiation therapy within 4 weeks prior starting study treatment, or limited field
of radiation for palliation within 7 days of the first dose of study treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
510
Recruitment in Australia
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Research Site - Camperdown
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Research Site - Chermside
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Research Site - Darlinghurst
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Research Site - Fitzroy
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Research Site - Kogarah
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Research Site - Kurralta Park
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Research Site - Malvern
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Research Site - Wendouree
Recruitment hospital [9] 0 0
Research Site - Woodville South
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
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4032 - Chermside
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2010 - Darlinghurst
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3065 - Fitzroy
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2217 - Kogarah
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5037 - Kurralta Park
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3144 - Malvern
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3355 - Wendouree
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5011 - Woodville South
Recruitment outside Australia
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Dnipro
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy of selumetinib in combination with
docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with
locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also
assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the
selumetinib/docetaxel combination, compared to placebo in combination with docetaxel
Trial website
https://clinicaltrials.gov/ct2/show/NCT01933932
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gabriella Mariani, MD
Address 0 0
AstraZeneca UK, MSD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01933932