Trial Outcomes & Findings for Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT02315430)
NCT ID: NCT02315430
Last Updated: 2020-03-10
Results Overview
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Every 8 weeks during treatment, assessesd up to 6 months for progression free survival.
Results posted on
2020-03-10
Participant Flow
The study was activated on 4/1/2015 and closed to accrual on 10/31/2016.
Participant milestones
| Measure |
Cabozantinib
Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Cabozantinib
n=13 Participants
Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 8 weeks during treatment, assessesd up to 6 months for progression free survival.Population: Eligible and Treated Patients
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.
Outcome measures
| Measure |
Cabozantinib
n=13 Participants
Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
The Percentage of Patients Who Survive Progression Free for at Least 6 Months
|
23 percentage of participants
Interval 7.0 to 49.0
|
PRIMARY outcome
Timeframe: Every 8 weeks during treatment;assessed up to 20 months.Population: Eligible and Treated Patients
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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.
Outcome measures
| Measure |
Cabozantinib
n=13 Participants
Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Objective Tumor Response
|
0 percentage of participants
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: Every cycle while on treatment, up to 30 days after treatment ends, an average of 14 months.Population: Eligible and Treated Patients
Grade 3 or higher adverse events were graded by CTC AE v 4.
Outcome measures
| Measure |
Cabozantinib
n=13 Participants
Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events
Nausea
|
3 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Pain
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Alanine aminotransferase increased
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Alkaline phosphatase increased
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Platelet count decreased
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Hypoalbuminemia
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Hyponatremia
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Back pain
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Bone pain
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Syncope
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Pleural effusion
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Hypertension
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Vomiting
|
3 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Thromboembolic Event
|
3 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Fatigue
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Dehydration
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Dyspnea
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Abdominal Pain
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Diarrhea
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Gastrointestinal Pain
|
1 participants
|
SECONDARY outcome
Timeframe: Tumor scan done every 8 weeks during treatment, Average progression free survival was 3.6 months.Population: Eligible and Treated Patients
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1
Outcome measures
| Measure |
Cabozantinib
n=13 Participants
Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Progression-free Survival
|
3.6 months
Interval 1.8 to 7.9
|
SECONDARY outcome
Timeframe: Every cycle during treatment, up to 20.1 months.Population: Eligible and Treated Patients
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Cabozantinib
n=13 Participants
Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Survival
|
8.1 Months
Interval 2.7 to
Length of overall survival was not reached at time of analysis, but is \>20.1 months
|
Adverse Events
Cabozantinib
Serious events: 6 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cabozantinib
n=13 participants at risk
Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Alanine Aminotransferase Increased
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Vascular disorders
Thromboembolic Event
|
23.1%
3/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
Other adverse events
| Measure |
Cabozantinib
n=13 participants at risk
Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
38.5%
5/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Cardiac disorders
Ventricular Tachycardia
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Endocrine disorders
Hypothyroidism
|
23.1%
3/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Eye disorders
Floaters
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Dry Mouth
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Constipation
|
38.5%
5/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Diarrhea
|
38.5%
5/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Vomiting
|
61.5%
8/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Bloating
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
53.8%
7/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Mucositis Oral
|
53.8%
7/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Oral Pain
|
23.1%
3/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Abdominal Distension
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Nausea
|
76.9%
10/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
General disorders
Pain
|
23.1%
3/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
General disorders
Fatigue
|
84.6%
11/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
General disorders
Fever
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Infections and infestations
Upper Respiratory Infection
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Infections and infestations
Lung Infection
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Weight Loss
|
38.5%
5/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Weight Gain
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Platelet Count Decreased
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Lipase Increased
|
30.8%
4/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Creatinine Increased
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Neutrophil Count Decreased
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Cardiac Troponin I Increased
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Blood Bilirubin Increased
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
White Blood Cell Decreased
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Aspartate Aminotransferase Increased
|
53.8%
7/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Alkaline Phosphatase Increased
|
53.8%
7/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Alanine Aminotransferase Increased
|
38.5%
5/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
23.1%
3/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
30.8%
4/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.8%
4/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.1%
3/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
46.2%
6/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
23.1%
3/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
30.8%
4/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Nervous system disorders
Memory Impairment
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Nervous system disorders
Hypersomnia
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Nervous system disorders
Headache
|
23.1%
3/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Nervous system disorders
Dysgeusia
|
61.5%
8/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Nervous system disorders
Dizziness
|
23.1%
3/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Renal and urinary disorders
Urinary Incontinence
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
38.5%
5/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.5%
5/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
23.1%
3/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.1%
3/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Vascular disorders
Thromboembolic Event
|
38.5%
5/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Vascular disorders
Hypertension
|
46.2%
6/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
|
Vascular disorders
Flushing
|
15.4%
2/13 • Study Treatment and up to 30 days after study treatment an average of 14 months.
|
Additional Information
Linda Gedeon on behalf of William Brady, PhD
NRG Oncology
Phone: 716-845-1169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60