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Taxane
Selumetinib + Docetaxel for Lung Cancer (SELECT-1 Trial)
Phase 3
Waitlist Available
Led By Pasi Jänne, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
SELECT-1 Trial Summary
This trial is testing whether adding selumetinib to docetaxel can help patients with advanced lung cancer live longer compared to those who just receive docetaxel.
Who is the study for?
This trial is for adults over 18 with advanced or metastatic non-small cell lung cancer (NSCLC) that's KRAS mutation positive. They must have had one failed anti-cancer therapy but can't have had MEK inhibitors, docetaxel regimens, other recent cancer treatments, or certain types of radiation.Check my eligibility
What is being tested?
The study tests the effectiveness of Selumetinib combined with Docetaxel against a placebo plus Docetaxel in patients with KRAS mutated NSCLC. It will also evaluate how the body processes the drugs, their safety, and patient-reported outcomes.See study design
What are the potential side effects?
Possible side effects include reactions to drug infusion, fatigue, digestive issues like nausea and diarrhea, blood disorders such as low white blood cell counts which may increase infection risk.
SELECT-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline until the date of first documented objective disease progression. estimated final completion : approximately 3 years after first subject in (fsi)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline until the date of first documented objective disease progression. estimated final completion : approximately 3 years after first subject in (fsi)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Duration of Response (DoR)
Objective Response Rate (ORR)
Overall Survival (OS)
+2 moreSide effects data
From 2012 Phase 2 trial • 37 Patients • NCT0108521475%
Diarrhea
50%
Fatigue
47%
Anemia
47%
Rash acneiform
44%
Hypoalbuminemia
44%
Edema, limbs
39%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
33%
White blood cell decreased
31%
Nausea
31%
Vomiting
28%
Platelet count decreased
25%
CPK increased
25%
Hypomagnesemia
22%
Hypertension
19%
Hypophosphatemia
19%
Hypocalcemia
19%
Hyponatremia
19%
Edema, face
17%
Dry skin
17%
Alanine aminotransferase increased
14%
Skin and subcutaneous tissue disorders - Other
14%
Hypokalemia
14%
Creatinine increased
14%
Back pain
14%
Dyspnea
14%
Lymphocyte count decreased
11%
Pain
11%
Fever
11%
Localized edema
11%
Peripheral sensory neuropathy
11%
Hyperkalemia
11%
Dizziness
11%
Abdominal pain
8%
Hypoglycemia
8%
Acute kidney injury
8%
Anorexia
8%
Death, NOS
8%
Periorbital edema
8%
Skin hypopigmentation
8%
Pain in extremity
8%
Cough
8%
Insomnia
8%
Alkaline phosphatase increased
8%
Dry mouth
8%
Sepsis
6%
Renal and urinary disorders - Other
6%
Dehydration
6%
Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis
6%
Hypernatremia
6%
Blood and lymphatic system disorders - Other
6%
Hypercalcemia
6%
Metabolism and nutrition disorders - Other
6%
Chills
6%
Hypotension
6%
Myalgia
6%
Arthralgia
6%
Upper respiratory infection
6%
Headache
6%
Sinusitis
6%
Generalized muscle weakness
6%
Gastrointestinal disorders - Other
6%
Gastroesophageal reflux disease
3%
Confusion
3%
Vaginal inflammation
3%
Pruritus
3%
Febrile neutropenia
3%
Flu like symptoms
3%
Hepatic failure
3%
Skin infection
3%
Fall
3%
Fracture
3%
Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral
3%
Adult respiratory distress syndrome
3%
Renal and urinary disorders - Other, Acute renal failure
3%
INR increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD6244 (Selumetinib) Treatment
SELECT-1 Trial Design
2Treatment groups
Experimental Treatment
Group I: Selumetinib + DocetaxelExperimental Treatment3 Interventions
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
Group II: Placebo + DocetaxelExperimental Treatment3 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegylated G-CSF
2015
Completed Phase 2
~10
Selumetinib
2010
Completed Phase 2
~2140
Docetaxel
1995
Completed Phase 4
~5620
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,286 Previous Clinical Trials
288,619,540 Total Patients Enrolled
Pasi Jänne, MDPrincipal InvestigatorDana-Faber Cancer Institute, USA
Gabriella Mariani, MDStudy ChairAstraZeneca UK, MSD
3 Previous Clinical Trials
1,037 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 18 years old or older.You have been diagnosed with advanced or metastatic non-small cell lung cancer.You have a specific mutation called KRAS in your tumor.Your cancer got worse or came back after trying the first treatment.You have a type of lung cancer that is a mix of small cell and non-small cell types.You are taking other cancer medications besides steroids.You have not been treated with a certain type of medication called a MEK inhibitor or a medication containing docetaxel.You have received more than one type of treatment for advanced or metastatic non-small cell lung cancer. If your cancer worsened while on a different treatment, you may not be eligible.
Research Study Groups:
This trial has the following groups:- Group 1: Selumetinib + Docetaxel
- Group 2: Placebo + Docetaxel
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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