Study of Regorafenib for Urothelial Cancer Following Chemotherapy (UAB 1477)

NCT02459119 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: F150302002 (UAB 1477)
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

This study will test how well Regorafenib controls disease progression in urothelial cancer (cancer occurring in the urinary bladder, ureters, or renal pelvis) following previous therapy with chemotherapy.

Conditions

Urothelial Cancer (Urinary Bladder, Ureters, or Renal Pelvis Cancer)

Keywords

urothelial cancer; Regorafenib

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression-free Survival at 6 Months

  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Death is also considered as progression in the analysis.

  Baseline to 6 months following start of treatment

Secondary Outcomes (4)

• Disease Response Rate

  Every 8 weeks until the time of disease progression upto 2 years

• Overall Survival

  Baseline to 3 years

• Rate of Progression-free Survival

  From start of treatment to time of progression or death, assessed up to 6 months

• Number of Participants With Adverse Events

  At the end of first treatment until 6 months following last treatment, an expected average of 10 months

Study Arms (1)

Regorafenib

EXPERIMENTAL

Regorafenib will be administered orally to all patients on study. The drug will be taken once a day for 3 of every 4 week cycle (3 weeks on/1 week off). The dose is 120 mg once daily for the first cycle, then 160 mg once daily from the second cycle if no significant Regorafenib-associated toxicities occur during the first cycle. Drug dosage may be modified if toxicities occur. Patients will undergo up to 4 cycles of treatment and may continue on additional at the discretion of the investigator.

Drug: Regorafenib

Interventions

Regorafenib DRUG

Regorafenib will be packaged as 40 mg tablets in a bottle. Patients will be instructed to maintain a daily medication calendar.

Regorafenib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have pathologically or cytologically proven transitional cell carcinoma of the urothelium.
• Progressive disease after 1-3 prior chemotherapy regimens (perioperative chemotherapy within 12 months will be considered one regimen).
• Prior regimen must be within 6 months of registration
• Measurable disease by RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
• Patients with metastatic (lymph node or distant metastasis, i.e. N+ or M1) or locally advanced unresectable (T4b) transitional cell carcinoma.
• Age ≥19 years
• Life expectancy of at least 12 weeks (3 months)
• Subjects must be able to understand and be willing to sign the written informed consent form.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
• Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
• Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
• Serum creatinine ≤ 1.5 x the ULN
• International normalized ratio (INR) less than or equal to 1.5 x ULN. (Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists.Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care.

You may not qualify if:

• Component of small-cell cancer or sarcomatoid cancer
• Prior therapy with any systemic therapy (chemotherapy or biologic therapy) within twenty-eight days prior to study entry
• Patients must have recovered from toxicities from prior systemic anticancer treatment or local therapies.
• Patients who have undergone major surgery \<4 weeks or minor surgery \<2 weeks prior to registration. Wounds must be completely healed prior to study entry and patients recovered from all toxicities from surgery. Placement of a vascular access device is not considered major or minor surgery in this regard.
• Prior radiation therapy is allowed as long as the irradiated area was not the sole source of measurable disease and radiotherapy was completed with recovery from toxicity, at least three weeks prior to enrollment. If the irradiated area is the only site of disease, there must be evidence of progressive disease.
• Uncontrolled central nervous system (CNS) metastases (previously treated with radiation and off steroids is acceptable).
• Patient with active or uncontrolled infection.
• Recent or active bleeding diathesis or arterial vascular event within 4 weeks.
• Pregnant or nursing (Fertile patients must use effective contraception during and for up to 3 months after completion of study treatment.)
• Patients may not be receiving any other investigational agents.
• Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
• Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic pressure \>90 mm Hg on repeated measurement) despite optimal medical management.
• Active or clinically significant cardiac disease including:
• Congestive heart failure - New York Heart Association (NYHA) Class II.
• Active coronary artery disease.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Wayne State University

Detroit, Michigan, 48201-2013, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

regorafenib

Results Point of Contact

• Title: Dr. Guru Sonpavde, MD
• Organization: Dana Farber Cancer Institute

gsonpavde@gmail.com

617-632-2429

Study Officials

• Lisle Nabell, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 1, 2015
• Study Start: May 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: April 1, 2020
• Last Updated: August 6, 2020
• Results First Posted: April 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)