Tucatinib Continuation Study

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

The purpose of this protocol is to give continued access to tucatinib eligible participants. It also enables ongoing safety follow-up for those who continue to benefit from the study treatment. These participants were part of Pfizer-sponsored tucatinib parent studies that will be closed. Additional follow-up safety information will be collected. This will allow further understanding of the safety profile of tucatinib in participants who continue to receive the study treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be receiving tucatinib as a study intervention and deriving clinical benefit without evidence of disease progression (as determined by the investigator) in a tucatinib Parent Study.

Agree to follow the reproductive criteria.

Be willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in this protocol.

Be capable of giving signed informed consent.

Disqualifiers

Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.

Current use of any prohibited concomitant medications(s) or unwillingness or inability to use a required concomitant medication(s).

Participants not previously enrolled or who have discontinued study intervention or who were randomized in the control arm in a Parent Study.

Trial design

Design model

Single group

Treatments tested in this trial

  • tucatinib

    Drug

    150 - 300 mg, by mouth, twice a day

Treatment groups

175 Participants
are divided into 1 treatment group
Group A: tucatinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To monitor the safety and tolerability of tucatinib

* Adverse events leading to permanent discontinuation of tucatinib * All serious adverse events

Time frame
Up to approximately 5 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: