Health TrialsbyHealthPanel

Zanzalintinib for Advanced Urothelial Carcinoma Progressing After Prior Therapy

ConditionAdvanced Urothelial Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuru Sonpavde

About this trial

This is a Phase II, single arm study. All subjects will receive Zanzalintinib 60 mg orally once daily until progression per RECIST 1.1 or intolerable toxicities or patient/investigator decision to discontinue study therapy. Radiology imaging will be performed every 8 weeks for 3 timepoints then every 12 weeks thereafter. A window of ± 7 days may be applied to all study visits to accommodate observed holidays, inclement weather, scheduling conflicts etc.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

Age ≥ 18 years at the time of consent.

Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 within 28 days prior to registration.

Histologically confirmed predominant urothelial carcinoma (T4b, N0, M0; any T, N1-N3, M0; any T, any N, M1). American Joint Committee on Cancer (AJCC) v8 staging manual. NOTE: must be locally advanced unresectable or metastatic.

Disqualifiers

More than 3 lines of prior therapy (prior cisplatin-based perioperative chemotherapy within 1 year prior to subsequent therapy or registration, whichever comes first) and/or prior perioperative PD1 inhibitor within 12 weeks prior to subsequent therapy (or registration, whichever comes first) is considered a line of therapy).

Prior receipt of a VEGF inhibitor.

Prior receipt of zanzalintinib.

Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 28 days before registration.

Trial design

Design model

Single group

Treatments tested in this trial

  • Zanzalintinib

    Drug

    60 mg orally once daily

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: ZanzalintinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

ORR is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST1.1.

Time frame
24 months

Secondary outcomes

1

Progression-free survival (PFS)

PFS is defined as the time from the date of study registration to the date of progression per RECIST 1.1 or death due to any cause, whichever occurs first.

Time frame
24 months
2

Duration of Response (DOR)

DOR is defined as the time from the first documented response (PR or CR) until the time of progression per RECIST 1.1 or death due to any cause.

Time frame
24 months
3

Overall survival (OS)

OS is defined as the time from the date of study registration to date of death due to any cause.

Time frame
24 months
4

Number of Participants with Adverse Events

Adverse events will be assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.

Time frame
24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Guru Sonpavde

Lead sponsor

Hoosier Cancer Research Network

Sponsor institution

Exelixis

Collaborator

Advent Health

Collaborator

Source ClinicalTrials.gov

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