Cancers With NTRK, ROS1, or ALK Gene FusionsNCT03066661
Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions
A study testing Entrectinib in people with Cancers With NTRK, ROS1, or ALK Gene Fusions, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3, ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for entrectinib. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancers With NTRK, ROS1, or ALK Gene Fusions
- What is being tested?
- Entrectinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of advanced cancer with an NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusion
- Unable to participate in an ongoing entrectinib (RXDX-101) clinical trial
- Willing and able to provide written, signed informed consent
- Medically suitable for treatment with entrectinib (RXDX-101)
Who cannot join
- Currently enrolled in an ongoing clinical study with any other investigational agent
Trial locations and contacts
1 site in 1 country.
United States1 site
1-844-Startrk (782-7875)
San Diego, California, 92121
About this study
Official title: Expanded Access to Entrectinib (RXDX-101) for the Treatment of Cancers With NTRK, ROS1, or ALK Gene Fusions
Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3, ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for entrectinib.
- Being tested
- Entrectinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntrectinibDrug
Also called RXDX-101
Open-label expanded access, capsules
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancers With NTRK, ROS1, or ALK Gene FusionsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066661
- Sponsor's protocol ID
- Entrectinib (RXDX-101) - EAP
- Status last verified
- Apr 2019
- First submitted
- 23 Feb 2017
- Last updated
- 26 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to Entrectinib (RXDX-101) for the Treatment of Cancers With NTRK, ROS1, or ALK Gene Fusions
- ClinicalTrials.gov ID
- NCT03066661
- Acronym / sponsor ID
- Entrectinib (RXDX-101) - EAP
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- First posted
- 28 Feb 2017 (actual)
- 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.
Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3, ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for entrectinib.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of advanced cancer with an NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusion
- Unable to participate in an ongoing entrectinib (RXDX-101) clinical trial
- Willing and able to provide written, signed informed consent
- Medically suitable for treatment with entrectinib (RXDX-101)
Key exclusion criteria (1 listed)
- Currently enrolled in an ongoing clinical study with any other investigational agent
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 |
|---|---|---|
| EntrectinibAlso: RXDX-101Open-label expanded access, capsules | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entrectinib in people with Cancers With NTRK, ROS1, or ALK Gene Fusions, run by Hoffmann-La Roche at 1 site in United States.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Apr 2019. 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 United States. 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 26 Apr 2019.