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

ConditionsCancer Renal Cell Carcinoma (RCC)Pancreatic Neuroendocrine Tumors (pNET)Extra-Pancreatic NET (epNET)Hepatocellular Carcinoma (HCC)Differentiated Thyroid Cancer (DTC)Non-Clear Cell Renal Cell Carcinoma (nccRCC)Colorectal Cancer Prostate Cancer

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorExelixis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

Cabozantinib
Drug
Administered as specified in the parent study.
Zanzalintinib
Drug
Administered as specified in the parent study.
Atezolizumab
Drug
Administered as specified in the parent study.
Nivolumab
Drug
Administered as specified in the parent study.
Abiraterone
Drug
Administered as specified in the parent study.
Prednisone
Drug
Administered as specified in the parent study.
Enzalutamide
Drug
Administered as specified in the parent study.

Treatment groups

5,000 Participants

are divided into 1 treatment group

Group A: Cabozantinib/ZanzalintinibExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame

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)

Locations

This trial has no locations.

Sponsors and contacts

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

Exelixis

Lead sponsor

Source ClinicalTrials.gov

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