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Tyrosine Kinase Inhibitor

Alectinib for Tumors (ALpha-T Trial)

Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
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 up to 5 years
Awards & highlights

ALpha-T Trial Summary

This study is evaluating whether alectinib may be effective for individuals with certain types of cancer.

Eligible Conditions
  • Tumors
  • Lung Cancer
  • Intestinal Tumors
  • Gastrointestinal Disorders
  • Bronchial Tumors
  • Colorectal Cancer
  • Papillary Thyroid Cancer
  • Gastrointestinal Disease
  • Pancreatic Cancer
  • Anaplastic Large Cell Lymphoma
  • Salivary Gland Tumors
  • Sarcoma
  • Head and Neck Cancers
  • Respiratory Diseases
  • Ovarian Tumors
  • Colonic Diseases
  • Intestinal Diseases
  • Central Nervous System
  • Melanoma
  • Thyroid Cancer
  • Neuroendocrine Tumors
  • Bile Duct Cancer
  • Brain Tumor
  • Gastrointestinal Tumors
  • Digestive System Tumors

ALpha-T Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Secondary outcome measures
CNS DOR by BICR Per RECIST v1.1
Central Nervous System (CNS) ORR by BICR Per RECIST v1.1
Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1
+10 more

Side effects data

From 2018 Phase 3 trial • 119 Patients • NCT02604342
24%
Fatigue
22%
Alopecia
16%
Asthenia
16%
Nausea
11%
Neutropenia
11%
Myalgia
11%
Decreased appetite
11%
Anaemia
11%
Constipation
11%
Cough
8%
Pruritus Generalised
8%
Pyrexia
8%
Paraesthesia
8%
Arthralgia
8%
Headache
5%
Pain in extremity
5%
Vomiting
5%
Tinnitus
5%
Febrile neutropenia
5%
Musculoskeletal Chest Pain
5%
Back pain
5%
Diarrhoea
5%
Dizziness
5%
Drug Hypersensitivity
5%
Oedema peripheral
5%
Neuropathy peripheral
3%
Gastroenteritis
3%
Abdominal pain
3%
Nasopharyngitis
3%
Stomatitis
3%
Upper Respiratory Tract Infection
3%
Lung infection
3%
Pneumonia bacterial
3%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Comparator: Premetrexed/Docetaxel
Experimental: Alectinib

ALpha-T Trial Design

1Treatment groups
Experimental Treatment
Group I: ALK-positive Solid TumorsExperimental Treatment1 Intervention
Participants with locally advanced or metastatic ALK-positive tumors will receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alectinib
2015
Completed Phase 3
~2400

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,089,053 Total Patients Enrolled
1 Trials studying Tumors
474 Patients Enrolled for Tumors
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,501 Total Patients Enrolled
2 Trials studying Tumors
1,135 Patients Enrolled for Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
2021. "A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04644315.
~0 spots leftby Apr 2025
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