Vactosertib with Durvalumab in Urothelial Carcinoma Faili... | NCT04064190

Studies
Vactosertib with Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

NCT04064190

Sponsor

MedPacto, Inc.

Status

Withdrawn

Last Update Posted

Dec 9, 2024Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Urothelial Carcinoma Recurrent
Advanced Urothelial Carcinoma

Interventions

Vactosertib(TEW-7197)/ Durvalumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Changing trial strategy

Expanded Access Info

Start Date

Dec 13, 2019Actual

Primary Completion Date

Dec 30, 2023Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Aug 15, 2019

First Submission Date that Met QC Criteria

Aug 19, 2019

First Posted Date

Aug 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2024

Last Update Posted Date

Dec 9, 2024Actual

Name	Class
AstraZeneca	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is Phase 2, open label, non randomized single arm study to determine whether the administration of vactosertib with durvalumab will provide meaningful increases in the Overall Response Rate (ORR) in patients with urothelial cancers that fail to achieve a response with anti-PD-1/PD-L1 based regimens

Detailed Description

This is a Phase 2, open-label, non-randomized, two-cohort multi center study with a safety run-in of 6 patients in Cohort 1. It is anticipated that a total of 48 patients will be enrolled.

Durvalumab will be administered with the standard regimen of 1500 mg intravenously (IV) every four weeks. Vactosertib will be administered at a dose of 300 mg PO BID for 5 days per week All treatment will be administered up to two years and the trial is anticipated to be completed over a period of 36 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vactosertib+Durvalumab	Experimental	Vactosertib will be administered in combination with standard dose of durvalumab every four weeks.	Drug: Vactosertib(TEW-7197)/ Durvalumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vactosertib(TEW-7197)/ Durvalumab	Drug	Vactosertib (PO) in combination with Durvalumab (IV) every 4 weeks	Vactosertib+Durvalumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Response Rate	ORR by RECIST version 1.1	12months

Secondary Outcomes

Measure	Description	Time Frame
Time to Tumor Response	TTR by RECIST version 1.1 and iRECIST	Overall study period up to 3years
Best Response	Best response (percent of tumor shrinkage) by RECIST version 1.1 and iRECIST

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment
Histologically or cytologically documented locally advanced/inoperable or metastatic urothelial bladder carcinoma (UBC), including renal pelvis, ureters, urinary bladder, and urethra.
Prior anti-PD-(L)1 treatment.
Measurable disease per RECIST 1.1 assessed by computed tomography (CT) scan or MRI.
Recurrent disease after any prior platinum-based chemotherapy regimen or ineligible for platinum therapy.
Adequate organ and marrow function as defined
Must have a life expectancy of at least 12 weeks.
Body weight > 30 kg

Exclusion Criteria:

History of allogeneic organ transplantation.
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure .
History of another primary malignancy
History of leptomeningeal carcinomatosis.
History of active primary immunodeficiency.
Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus .
Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lawrence Fong, MD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Francisco		San Francisco	California	94158	United States
Roswell Park Comprehensive Cancer Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided