Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study

NCT07620574
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Enrolling by invitation
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Participants
5,000
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Lead sponsor
Exelixis
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Start date
2026-07-30
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Number of sites
2
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Summary
The primary objective of this long-term extension study is to allow continued access to study treatment for eligible participants who are deriving clinical benefit in an Exelixis-sponsored study who do not have access to treatment locally.
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Short title
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
clinicaltrials.gov
Official title
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
clinicaltrials.gov

Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Enrolling by invitation
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-05-31
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First posted
2026-06-02
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Registry last updated
2026-08-18
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Primary completion date
2030-05-31
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Start date
2026-07-30
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Participants
5,000
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Participant count basis
Estimated
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Planned participants
5,000
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Protocol amendments
1
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Number of sites
2
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Exelixis
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07620574
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ClinicalTrials.gov ID
NCT07620574
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to 4 years (until the event resolves, returns to baseline, stabilizes, a new anticancer therapy is initiated, or the participant is lost to follow-up or withdraws consent, whichever occurs first)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Healthy volunteers
No

Key Inclusion Criteria:

  • Eligible to continue receiving the study treatment in the parent study (that is, has not met parent study discontinuation/withdrawal criteria).
  • Continuing to derive clinical benefit from the study treatment at the time of transition from the parent study as assessed by the investigator.
  • Able to comply with the long-term extension study protocol as determined by the investigator.
  • Able to receive the first dose of study treatment in this extension study within the specified treatment interruption window allowed by the parent study.

Key Exclusion Criteria:

  • Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study.
  • Study treatment is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant.
  • Treatment with any anticancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this long-term extension study.
  • Permanent discontinuation of all study treatment(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this long-term extension study (if applicable).
  • Concurrent participation in any therapeutic clinical trial (other than the parent study).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

  • New York Cancer and Blood SpecialistsBay Shore, United States
  • Greater Dayton Cancer CenterKettering, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2026-525795-26-00
Sources for references
clinicaltrials.gov

Related records

Drugs (7)

Collaborators (1)

Lead sponsors (1)

Conditions (6)

Targets (7)