Solid TumorsPhase 2NCT02506517
A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene
A Phase 2 study testing Afatinib in people with Solid Tumors, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a phase 2 study (the second phase in testing a new drug) to see how useful an investigational drug called afatinib is in patients with advanced cancer with changes in the HER gene. Afatinib is a drug that is approved by Health Canada for the treatment of advanced lung cancer with changes in the HER gene. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Afatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to 4 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may have had any number of treatment lines in the curative or metastatic setting for their solid tumors.
- Age 18 years or older.
- At least one measurable lesion
- In patients with previous treatment, evidence of progression of cancer, as per the opinion of the investigator must be present
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate organ function
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- Willingness to undergo fresh tumor biopsy at certain timepoints
- Recovered from any previous therapy related side effects
- Able to provide written consent
Who cannot join
- Chemotherapy, biological therapy or investigational agents within 3 weeks prior to the start of study treatment.
- Hormonal treatment within 3 weeks prior to start of study treatment.
- Radiotherapy within 3 weeks prior to randomization with exceptions
- Major surgery within 3 weeks before starting study treatment or scheduled for surgery during the projected course of the study
- Known exposure to any epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER) 2, HER3 or pan-HER inhibitors, such as, but not limited to afatinib or dacomitinib.
- Patients with inability to swallow whole tablets for afatinib are allowed on the study, but diluted tablets must be taken orally.
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- Presence of malabsorption problems including, but not exclusively limited to chronic diarrhea and uncontrolled inflammatory bowel disease.
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to study entry
- Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 28 days after treatment has ended.
- Female patients of childbearing potential who are nursing or are pregnant or are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and/or do not agree to submit to pregnancy testing required by the study.
- Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the study drug
- Previous or concomitant malignancies at other sites, with exceptions
- Requiring treatment with any of the prohibited concomitant medications
- Known pre-existing interstitial lung disease
- Any history or presence of poorly controlled gastrointestinal disorders.
- Known active hepatitis B, active hepatitis C infection and/or known HIV carrier.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies
This is a phase 2 study (the second phase in testing a new drug) to see how useful an investigational drug called afatinib is in patients with advanced cancer with changes in the HER gene.
Afatinib is a drug that is approved by Health Canada for the treatment of advanced lung cancer with changes in the HER gene. Afatinib works by attaching to and blocking a protein called HER from working. HER is an important protein that contributes to the growth of cancer cells.
- Conditions
- Solid Tumors
- Being tested
- Afatinib
- Keywords
- HER pathway aberrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
Also called GIOTRIF
| Study group | Role | What they receive |
|---|---|---|
| Afatinib | Experimental | Afatinib, orally, at a dose of 40 mg once a day, every day of each 28 day cycle. Receives: Drug: Afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complete response
Measured: 2 years
Number of patients with partial response
Measured: 2 years
Secondary outcomes (5)
Number of Grade 1 side effects
Measured: 2 years
Number of Grade 2 side effects
Measured: 2 years
Number of Grade 3 side effects
Measured: 2 years
Number of Grade 4 side effects
Measured: 2 years
Timeframe of Progression Free Survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Albiruni Razak, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506517
- Sponsor's protocol ID
- MOBILITY-003
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2015
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salawu A, Hansen AR, Spreafico A, Al-Ezzi E, Webster S, Bedard PL, Doi J, Wang L, Siu LL, Abdul Razak AR. A Phase 2 Trial of Afatinib in Patients with Solid Tumors that Harbor Genomic Aberrations in the HER family: The MOBILITY3 Basket Study. Target Oncol. 2022 May;17(3):271-281. doi: 10.1007/s11523-022-00884-z. Epub 2022 May 30.
PubMed 35635640
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies
- ClinicalTrials.gov ID
- NCT02506517
- Acronym / sponsor ID
- MOBILITY-003
- Conditions
- Solid Tumors
- Keywords
- HER pathway aberrations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Aug 2015
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2 study (the second phase in testing a new drug) to see how useful an investigational drug called afatinib is in patients with advanced cancer with changes in the HER gene.
Afatinib is a drug that is approved by Health Canada for the treatment of advanced lung cancer with changes in the HER gene. Afatinib works by attaching to and blocking a protein called HER from working. HER is an important protein that contributes to the growth of cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afatinib | Experimental | Drug: AfatinibAfatinib, orally, at a dose of 40 mg once a day, every day of each 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients may have had any number of treatment lines in the curative or metastatic setting for their solid tumors.
- Age 18 years or older.
- At least one measurable lesion
- In patients with previous treatment, evidence of progression of cancer, as per the opinion of the investigator must be present
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Key exclusion criteria (16 listed)
- Chemotherapy, biological therapy or investigational agents within 3 weeks prior to the start of study treatment.
- Hormonal treatment within 3 weeks prior to start of study treatment.
- Radiotherapy within 3 weeks prior to randomization with exceptions
- Major surgery within 3 weeks before starting study treatment or scheduled for surgery during the projected course of the study
- Known exposure to any epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER) 2, HER3 or pan-HER inhibitors, such as, but not limited to afatinib or dacomitinib.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfatinibAlso: GIOTRIF | Drug | Afatinib |
Primary outcome
Number of patients with complete response
Time frame: 2 years
Number of patients with partial response
Time frame: 2 years
5 secondary outcomes
Number of Grade 1 side effects
Time frame: 2 years
Number of Grade 2 side effects
Time frame: 2 years
Number of Grade 3 side effects
Time frame: 2 years
Number of Grade 4 side effects
Time frame: 2 years
Timeframe of Progression Free Survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 35635640Salawu A, Hansen AR, Spreafico A, Al-Ezzi E, Webster S, Bedard PL, Doi J, Wang L, Siu LL, Abdul Razak AR. A Phase 2 Trial of Afatinib in Patients with Solid Tumors that Harbor Genomic Aberrations in the HER family: The MOBILITY3 Basket Study. Target Oncol. 2022 May;17(3):271-281. doi: 10.1007/s11523-022-00884-z. Epub 2022 May 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albiruni Razak, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afatinib in people with Solid Tumors, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with complete response (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.