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

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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Key information

Conditions

Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Carcinoma, Renal Cell Colonic Diseases Colorectal Cancer Colorectal Neoplasms Differentiated Thyroid Cancer (DTC) Digestive System Diseases Digestive System Neoplasms Extra-Pancreatic NET (epNET) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hepatocellular Carcinoma (HCC) Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Clear Cell Renal Cell Carcinoma (nccRCC) Pancreatic Neuroendocrine Tumors (pNET) Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Renal Cell Carcinoma (RCC) Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.