Academic Thoracic Oncology Medical Investigators Consortium
Who can join
Adults 18 to 99, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
12-Week Progression Free SurvivalPrimary· This outcome was assessed at the 12-week assessment. Subjects without the 12-week assessment but who had at least 11 weeks of treatment were included.
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 t
Group
Value
95% CI
Oral Cabozantinib
18
12-Week Progression-Free Survival by RAS Mutation StatusSecondary· This outcome was assessed at the 12-week assessment. Subjects without the 12-week assessment but who had at least 11 weeks of treatment were included.
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.
Group
Value
95% CI
RAS Mutant
7
RAS Wild Type
11
12-Week Progression-Free Survival by PIK3CA Mutation StatusSecondary· This outcome was assessed at the 12-week assessment. Subjects without the 12-week assessment but who had at least 11 weeks of treatment were included.
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.
Group
Value
95% CI
PIK3CA Mutant
3
PIK3CA Wild Type
11
Progression-Free Survival (PFS)Secondary· Study start date to study end date, or death, whichever comes first, up to 24 months
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.
Group
Value
95% CI
Oral Cabozantinib
13
9 – 21
Progression-Free Survival (PFS) by RAS Mutation StatusSecondary· Study start date to study end date, or death, whichever comes first, up to 24 months
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.
Group
Value
95% CI
RAS Mutant
12
6 – 14
RAS Wild Type
21
9 – 48
Progression-Free Survival (PFS) by PIK3CA Mutation StatusSecondary· Study start date to study end date, or death, whichever comes first, up to 24 months
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.
Group
Value
95% CI
PIK3CA Mutant
26
5 – NA
PIK3CA Wild Type
20
6 – 29
Response Rate in Patients With CRC Treated With CabozantinibSecondary· Study start date to study end date, or death, whichever comes first, up to 24 months
\*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.
Group
Value
95% CI
Oral Cabozantinib
1
Overall Survival (OS) in Patients With CRC Treated With CabozantinibSecondary· Study start date to study end date, or death, whichever comes first, up to 24 months
Overall Survival will be defined as the time from administration of the initial dose of cabozantinib until death from any cause.
Group
Value
95% CI
Oral Cabozantinib
36
24 – 50
Overall Survival (OS) by RAS Mutation StatusSecondary· Study start date to study end date, or death, whichever comes first, up to 24 months
This has the same outcome measure description as the OS analysis.
Group
Value
95% CI
RAS Mutant
30
18 – 46
RAS Wild Type
45
20 – NA
Overall Survival (OS) by PIK3CA Mutation StatusSecondary· Study start date to study end date, or death, whichever comes first, up to 24 months
This has the same outcome measure description as the OS analysis.
Group
Value
95% CI
PIK3CA Mutant
92
9 – NA
PIK3CA Wild Type
36
20 – 85
Adverse events — posted to ClinicalTrials.gov
Time frame: 45 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Oral Cabozantinib
Serious: 20/44 (45%)
Deaths: 5/44
Serious adverse events (28 terms)
Reaction
System
Oral Cabozantinib
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
—
Disease Progression
General disorders
—
dyspnea
Respiratory, thoracic and mediastinal disorders
—
GI bleed
Gastrointestinal disorders
—
Lung infection
Respiratory, thoracic and mediastinal disorders
—
Cavitating Pulmonary Nodules
Respiratory, thoracic and mediastinal disorders
—
Abdominal Pain
Gastrointestinal disorders
—
Acute Cerebrovascular Accident
General disorders
—
Acute Pancreatitis
Gastrointestinal disorders
—
Acute Renal Failure
Renal and urinary disorders
—
Back Pain
General disorders
—
Bowel Perforation
Gastrointestinal disorders
—
Constipation
Gastrointestinal disorders
—
Dehydration
General disorders
—
difficulty speaking
General disorders
—
Disseminated Intravascular Coagulation
Blood and lymphatic system disorders
—
Duodenal fistula
Gastrointestinal disorders
—
Failure to Thrive
General disorders
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
nausea
Gastrointestinal disorders
—
Bowel Obstruction
Gastrointestinal disorders
—
Pneumonia
Respiratory, thoracic and mediastinal disorders
—
Progressed Malignant Neoplasm
General disorders
—
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
—
Severe Complicated Bilateral Pyelonephritis
Renal and urinary disorders
—
Other adverse events (124 terms — click to expand)
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Other Academic Thoracic Oncology Medical Investigators Consortium trials
Trials by the same sponsor.
NCT02879617 — A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Academic Thoracic Oncology Medical Investigators Consortium
Last refreshed: 15 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03542877.