Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.

Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.

Oral Tablet: Cabozantinib

Wells Messersmith, MD

This study seeks to use Cabozantinib to treat those with Metastatic Colorectal Cancer who have not previously responded to treatment.

This is a phase II clinical trial that seeks to use Cabozantinib to treat those with Metastatic Colorectal Cancer who have not previously responded to treatment. This study is a two stage study that will first measure (up to) 16 patients' progression free survival (PFS). Stage two will, again, measure PFS, but in a population (up to) 28 patients.

Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer

An Open-Label, Single-Arm, Two-Stage Phase II Study Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer

A patient is classified as progression-free if s/he is assessed as not having progressive disease (PD) as defined per RECIST 1.1 criteria at either the 12-week assessment or after having at least 11 weeks of treatment for subjects without the 12-week assessment. Censored patients (i.e. those who have not progressed but who are missing a 12-week assessment) are not included in the analysis. Subjects who didn't have the 12-week assessment but who had clinical progression were included and considered to have progressed.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

This has the same outcome measure description as the primary analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Progression-free survival will be defined as the time from administration of the initial dose of cabozantinib to evidence of radiographic progression as defined by RECIST criteria or death from any cause without evidence of disease progression, whichever occurs first.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

This has the same outcome measure description as the PFS analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

\*A patient is classified as a responder if s/he is assessed as having complete response or partial response (CR or PR) at the time of any assessment, where CR and PR are defined per RECIST 1.1 criteria.

Overall Survival will be defined as the time from administration of the initial dose of cabozantinib until death from any cause.

This has the same outcome measure description as the OS analysis.

University of Colorado, Denver

Academic Thoracic Oncology Medical Investigators Consortium

Patients will be enrolled to take 60mg of cabozantinib, by mouth, once a day, every day, for 12 weeks. If less than three patients have Progression Free Survival (PFS) lasting at least 12 weeks, the study will be terminated.

Oral Tablet: Cabozantinib: Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.

Oral Cabozantinib

Age, Categorical

Age, Continuous

Female

Male

Unknown

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Wells Messersmith

40 of the 44 subjects were in the analysis population. 3 subjects were not included because they didn't have treatment response data, and 1 subject was not included because that subject didn't reach at least week 11 (and didn't have PD).

12-Week Progression Free Survival

RAS Mutant

Subjects with wild type RAS mutation status

RAS Wild Type

This population was the same as the population for the primary analysis

12-Week Progression-Free Survival by RAS Mutation Status

PIK3CA Mutant

Subjects with wild type PIK3CA mutation status.

PIK3CA Wild Type

All subjects in the primary analysis who had data regarding their PIK3CA mutation status.

12-Week Progression-Free Survival by PIK3CA Mutation Status

3 of the 44 study subjects were not included in this analysis population because they didn't have treatment response data.

Progression-Free Survival (PFS)

Progression-Free Survival (PFS) by RAS Mutation Status

All subjects in the PFS secondary analysis who had data regarding their PIK3CA mutation status.

Progression-Free Survival (PFS) by PIK3CA Mutation Status

This analysis population was the same as described for the primary analysis.

Response Rate in Patients With CRC Treated With Cabozantinib

All 34 subjects with follow-up data (i.e. data in the 'dataset_survival_follow_up.xlsx' table) were included in the analysis.

Overall Survival (OS) in Patients With CRC Treated With Cabozantinib

Overall Survival (OS) by RAS Mutation Status

All subjects in the secondary OS analysis who had data regarding their PIK3CA mutation status.

Spots Global Cancer Trial Database for Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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