> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/long-term-extension-study-for-participants-previously-1f9d623b-4584-41d7-bd30-d9e8f8906175 > Record changed: 2026-10-13 # Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study NCT07620574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) Recruitment status Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) Participants 5,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) Lead sponsor Exelixis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) Start date 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Short title** Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Official title** Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Recruitment status** Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## Dates **Completion date** 2030-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **First posted** 2026-06-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Registry last updated** 2026-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Primary completion date** 2030-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Start date** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## Size and sites **Participants** 5,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Planned participants** 5,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Lead sponsor** Exelixis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## Identifiers **Registry ID** NCT07620574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **ClinicalTrials.gov ID** NCT07620574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## Outcomes ### Primary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## Sites - New York Cancer and Blood SpecialistsBay Shore, United States - Greater Dayton Cancer CenterKettering, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## References ### Other registry identifiers - 2026-525795-26-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07620574) ## Related records ### Drugs (7) - [Abiraterone acetate](https://trialight.com/data/asset/abiraterone-acetate-2c6662c6-31e9-49ed-a022-f76f326fbd3e.md) - [Atezolizumab](https://trialight.com/data/asset/atezolizumab-2cce6944-73b7-49f4-8125-4e6747997b82.md) - [Cabozantinib](https://trialight.com/data/asset/cabozantinib-e69f9fa7-bbbc-4e52-b0df-6073598de2a7.md) - [Enzalutamide](https://trialight.com/data/asset/enzalutamide-d1214ac0-68e5-4752-9999-977e028ec483.md) - [Nivolumab](https://trialight.com/data/asset/nivolumab-d2e207ca-a7d1-43d0-987f-43ef7eef8f1b.md) - [Prednisone](https://trialight.com/data/asset/prednisone-a5a99f90-5fbe-45c2-a625-34ba78735da6.md) - [Zanzalintinib](https://trialight.com/data/asset/zanzalintinib-0a1dc103-7c01-43a8-bc9a-bbc2b2e81de6.md) ### Collaborators (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Lead sponsors (1) - [Exelixis](https://trialight.com/data/company/exelixis-437e6f09-d9c9-4745-8dc3-30630876787f.md) ### Conditions (6) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) - [Primitive neuroectodermal tumor](https://trialight.com/data/condition/primitive-neuroectodermal-tumor-71cd5bfd-1a43-5b21-95c2-d8c45fabbc28.md) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) - [Renal cell carcinoma](https://trialight.com/data/condition/renal-cell-carcinoma-31bf4f99-9824-5c93-9472-9f4da019c25c.md) ### Targets (7) - [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [MET](https://trialight.com/data/target/met-f2eb67de-39d3-5026-b4c1-2c5017d5c5b2.md) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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