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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline until the date of first documented objective disease progression. estimated final completion : approximately 3 years after first subject in (fsi) for reporting.

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 more

Side effects data

From 2012 Phase 2 trial • 37 Patients • NCT01085214

75%

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

Hypoglycemia

Acute kidney injury

Anorexia

Death, NOS

Periorbital edema

Skin hypopigmentation

Pain in extremity

Cough

Insomnia

Alkaline phosphatase increased

Dry mouth

Sepsis

Renal and urinary disorders - Other

Dehydration

Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis

Hypernatremia

Blood and lymphatic system disorders - Other

Hypercalcemia

Metabolism and nutrition disorders - Other

Chills

Hypotension

Myalgia

Arthralgia

Upper respiratory infection

Headache

Sinusitis

Generalized muscle weakness

Gastrointestinal disorders - Other

Gastroesophageal reflux disease

Confusion

Vaginal inflammation

Pruritus

Febrile neutropenia

Flu like symptoms

Hepatic failure

Skin infection

Fall

Fracture

Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral

Adult respiratory distress syndrome

Renal and urinary disorders - Other, Acute renal failure

INR increased

100%

80%

60%

40%

20%

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

~2050

Docetaxel

1995

Completed Phase 4

~5620

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,262 Previous Clinical Trials

288,594,732 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

Media Library

Docetaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT01933932 — Phase 3

Lung Cancer Research Study Groups: Selumetinib + Docetaxel, Placebo + Docetaxel

Lung Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT01933932 — Phase 3

Docetaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01933932 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main ailments that Selumetinib has been shown to improve?

"Selumetinib is most often used to mitigate the effects of radiation syndrome, but it has also been effective in treating metastatic bladder cancer, bone marrow transplantation patients, and neoplasm metastasis."

Answered by AI

Are scientists looking for more participants in this research project?

"Unfortunately, this study is no longer recruiting patients for participation. The clinical trial was posted on September 25th, 2013 and updated for the last time on September 20th, 2022. However, there are other ongoing studies that might be of interest; as of right now, there are 1951 trials actively recruiting participants with locally advanced or metastatic non small cell lung cancer stage iiib - iv and 539 studies for Selumetinib looking for patients."

Answered by AI

Are there other examples where Selumetinib has been tested in a controlled setting?

"539 clinical trials are currently underway for Selumetinib. 173 of these ongoing studies are in Phase 3. The majority of the trials taking place for Selumetinib are based in Fuzhou, Fujian; however, 29376 locations worldwide are running similar investigations."

Answered by AI

When was Selumetinib approved by the FDA?

"Selumetinib has received a score of 3 from our Power team. This is because it is a Phase 3 trial, signifying that there are both efficacy and safety data supporting its use."

Answered by AI