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Tyrosine Kinase Inhibitor

Afatinib for Solid Tumors

Phase 2

Waitlist Available

Led By Albiruni Razak, M.D.

Research Sponsored by University Health Network, Toronto

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 2 years

Awards & highlights

Study Summary

This trial will test how well afatinib works in patients with other types of cancer that have changes in the HER gene.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Number of patients with complete response

Number of patients with partial response

Secondary outcome measures

Number of Grade 1 side effects

Number of Grade 2 side effects

Number of Grade 3 side effects

+2 more

Side effects data

From 2017 Phase 4 trial • 60 Patients • NCT02208843

73%

Diarrhoea

30%

Rash

23%

Paronychia

22%

Hypokalaemia

20%

Mucosal inflammation

20%

Anaemia

20%

Nausea

15%

Dermatitis acneiform

15%

Fatigue

10%

Vomiting

10%

Dermatitis

Weight decreased

Decreased appetite

Gamma-glutamyltransferase increased

Abdominal pain upper

Dry skin

Pruritus

Stomatitis

Hyponatraemia

Hyperglycaemia

Back pain

Nail pitting

Acne

Dizziness

Hypocalcaemia

Leukopenia

Hypomagnesaemia

Cough

Acute kidney injury

Pneumonia

Brain oedema

Seizure

Malignant neoplasm progression

Disease progression

Cardiac arrest

Hemiparesis

Nervous system disorder

Deep vein thrombosis

Blood creatinine increased

Epilepsy

Malignant pleural effusion

Neurological decompensation

100%

80%

60%

40%

20%

Study treatment Arm

Afatinib 40 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: AfatinibExperimental Treatment1 Intervention

Afatinib, orally, at a dose of 40 mg once a day, every day of each 28 day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Afatinib

2016

Completed Phase 4

~2340

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,168 Total Patients Enrolled

Boehringer IngelheimIndustry Sponsor

2,507 Previous Clinical Trials

11,340,895 Total Patients Enrolled

Albiruni Razak, M.D.Principal InvestigatorPrincess Margaret Cancer Centre

3 Previous Clinical Trials

121 Total Patients Enrolled

Frequently Asked Questions

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

Is this experimental research the inaugural effort of its kind?

"Since its initial trial in 2012, sponsored by Boehringer Ingelheim and involving 42 patients, Afatinib has slowly become more widespread. The drug went on to receive Phase 2 approval before being trialed across 913 cities spread over 30 countries with a total of 32 active trials ongoing as of today."

Answered by AI

What is the target enrolment for this clinical research?

"This medical research has concluded its recruitment process. The trial was initially posted on August 1st 2015, and the last update happened in May 12th 2022. An individual looking for other ongoing clinical trials may find 450 studies involving tumour-related illness that are currently recruiting patients as well 32 investigations investigating Afatinib admitting new participants."

Answered by AI

Are participants being accepted for this clinical investigation at present?

"This research effort is no longer enrolling patients; its initial posting was on August 1st 2015 while the most recent edit occurred in May of 2022. For those looking for alternative studies, there are 450 trials recruiting individuals with tumors and 32 that accept Afatinib participants."

Answered by AI

To what degree is Afatinib hazardous to individuals' health?

"The safety of Afatinib was assigned a score of 2, as clinical evidence currently only supports its safety but not efficacy."

Answered by AI

What other experiments utilizing Afatinib have been conducted?

"Currently, there are 32 active clinical studies for Afatinib with two in their final phase of testing. While Nagoya-shi, Aichi is home to several trials, a total of 2060 locations have been established as trial sites."

Answered by AI

Recent research and studies

Targeted OncologyJournal

A Phase 2 Trial of Afatinib in Patients with Solid Tumors That Harbor Genomic Aberrations in the HER Family: The MOBILITY3 Basket Study

Salawu, Abdulazeez, Aaron R. Hansen, Anna Spreafico, Esmail Al-Ezzi, Sheila Webster, Philippe L. Bedard, Jeffrey Doi, Lisa Wang, Lillian L. Siu, and Albiruni R. Abdul Razak. 2022. “A Phase 2 Trial of Afatinib in Patients with Solid Tumors That Harbor Genomic Aberrations in the HER Family: The MOBILITY3 Basket Study”. Targeted Oncology. Springer Science and Business Media LLC. doi:10.1007/s11523-022-00884-z.

clinicaltrials.govStudy

A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene

2015. "A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02506517.