NCT01835158|CompletedPhase 2Results

Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer

Randomized Phase II Study Comparing Cabozantinib (NSC #761968) With Commercially Supplied Sunitinib in Patients With Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma

National Cancer Institute (NCI)ClinicalTrials.gov

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4 other identifiers

NCI-2013-00820A031203U10CA180821U10CA031946

Study Type

interventional

Target

157

Locations

1 country

Sites

488

Timeline

RegisteredApr 2013

StartedJul 2013

Brief Summary

This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

157

participants targeted

Target at P75+ for phase_2

Geographic Reach

1 country

488 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed

3 months until next milestone

Study Start

First participant enrolled

July 8, 2013

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2016

Completed

2.7 years until next milestone

Results Posted

Study results publicly available

December 21, 2018

Completed

Last Updated

February 11, 2021

Status Verified

December 1, 2020

Enrollment Period

2.8 years

First QC Date

April 16, 2013

Results QC Date

October 23, 2018

Last Update Submit

January 28, 2021

Conditions

Clear Cell Renal Cell Carcinoma Metastatic Kidney Carcinoma Stage III Renal Cell Cancer AJCC v7 Stage IV Renal Cell Cancer AJCC v7

Outcome Measures

Primary Outcomes (2)

Progression Free Survival (PFS)
Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published
Up to 5 years
Overall Survival (OS)
The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on OS. The Kaplan-Meier product-limit estimator will be used to estimate OS distributions.
Up to 5 years

Secondary Outcomes (1)

Objective Response Rates
Up to 5 years

Study Arms (2)

Arm I (cabozantinib-s-malate)

ACTIVE COMPARATOR

Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Cabozantinib S-malateOther: Laboratory Biomarker Analysis

Arm II (sunitinib malate)

ACTIVE COMPARATOR

Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisDrug: Sunitinib Malate

Interventions

Cabozantinib S-malateDRUG

Given PO

Also known as: BMS-907351, Cabometyx, Cometriq, XL-184, XL184

Arm I (cabozantinib-s-malate)

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (cabozantinib-s-malate)Arm II (sunitinib malate)

Sunitinib MalateDRUG

Given PO

Also known as: SU011248, SU11248, sunitinib, Sutent

Arm II (sunitinib malate)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Renal cell carcinoma with some component of clear cell histology; histologic documentation of metastatic disease is not required
Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma (RCC) (equivalent to stage IV RCC, according to American Joint Committee on Cancer \[AJCC\] staging)
Eligible patients must be intermediate/poor risk, per the International Metastatic Renal Cell Carcinoma (mRCC) Database Consortium (Heng) criteria; patients must therefore have as one or more of the following six factors:
Time from diagnosis of RCC to systemic treatment \< 1 year
Note: systemic treatment refers to the initiation of A031203 protocol treatment
Hemoglobin \< the lower limit of normal (LLN)
Corrected calcium \> the upper limit of normal (ULN)
Karnofsky performance status \< 80%
Neutrophil count \> ULN
Platelet count \> ULN
No radiographic evidence of cavitating pulmonary lesion(s)
No tumor invading the inferior vena cava (IVC) or superior vena cava (SVC) blood vessels
No evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days prior to registration
No prior systemic treatment for RCC; supportive therapies such as bisphosphonates (zoledronic acid) or denosumab are permitted
Patients must not have had a major surgical procedure or significant traumatic injury within 6 weeks prior to study registration, and must have fully recovered from any such procedure; however, patients who have had a nephrectomy may be enrolled 4 weeks after surgery, providing there are no wound-healing complications; the following are not considered to be major procedures: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures
+47 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (488)

Southern Cancer Center PC-Providence

Mobile, Alabama, 36608, United States

Location

Alaska Breast Care and Surgery LLC