Trial Outcomes & Findings for Cabozantinib (XL184) in Patients With Relapsed or Refractory Myeloma (NCT NCT01866293)
NCT ID: NCT01866293
Last Updated: 2017-08-30
Results Overview
This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
1 year
Results posted on
2017-08-30
Participant Flow
Protocol Open to Accrual 05/28/2013 Protocol Closed to Accrual 09/16/2015 Primary Completion Date 08/18/2016 Recruitment Location is the medical clinic
Participant milestones
| Measure |
Cabozantinib (XL184)
Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
Cabozantinib (XL184)
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Cabozantinib (XL184)
Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
Cabozantinib (XL184)
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Cabozantinib (XL184) in Patients With Relapsed or Refractory Myeloma
Baseline characteristics by cohort
| Measure |
Cabozantinib (XL184)
n=11 Participants
Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
Cabozantinib (XL184)
|
|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 9 participants are evaluable. 2 participants never started treatment.
This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=11 Participants
Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
|
|---|---|
|
Maximally Tolerated Dose
|
40 mg
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 9 participants are evaluable. 2 participants never started treatment.
IMWG Criteria for Response, Progression and Relapse in Multiple Myeloma Patients
Outcome measures
| Measure |
Cabozantinib (XL184)
n=11 Participants
Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
|
|---|---|
|
Overall Response Rate
Progression of disease
|
2 Participants
|
|
Overall Response Rate
Stable disease
|
6 Participants
|
|
Overall Response Rate
N/A - off study before disease evaluation
|
1 Participants
|
|
Overall Response Rate
Did not start study treatment
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearSafety assessments and toxicity grading will follow CTCAE Version 4 Grade
Outcome measures
| Measure |
Cabozantinib (XL184)
n=11 Participants
Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
|
|---|---|
|
Safety and Toxicity in This Patient Population
Evaluable
|
9 Participants
|
|
Safety and Toxicity in This Patient Population
Unevaluable - Enrolled but never started treatment
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 9 participants are evaluable. 2 participants never started treatment.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=11 Participants
Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
|
|---|---|
|
Time to Progression (TTP)
|
57 days
Interval 28.0 to 85.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 9 participants are evaluable. 2 participants never started treatment.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=11 Participants
Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
|
|---|---|
|
Duration of Response (DOR)
|
63.5 days
Interval 43.0 to 85.0
|
Adverse Events
Cabozantinib (XL184)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cabozantinib (XL184)
n=11 participants at risk
Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • 1 year
|
|
General disorders
Fever
|
9.1%
1/11 • 1 year
|
|
Cardiac disorders
Heart failure
|
9.1%
1/11 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
9.1%
1/11 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
9.1%
1/11 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
18.2%
2/11 • 1 year
|
|
Nervous system disorders
Syncope
|
9.1%
1/11 • 1 year
|
Other adverse events
| Measure |
Cabozantinib (XL184)
n=11 participants at risk
Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
|
|---|---|
|
General disorders
Fatigue
|
63.6%
7/11 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
54.5%
6/11 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.4%
4/11 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
27.3%
3/11 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
27.3%
3/11 • 1 year
|
|
General disorders
Pain
|
27.3%
3/11 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
18.2%
2/11 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
18.2%
2/11 • 1 year
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
18.2%
2/11 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.2%
2/11 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
18.2%
2/11 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
1/11 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
9.1%
1/11 • 1 year
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, spec
|
9.1%
1/11 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
9.1%
1/11 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • 1 year
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • 1 year
|
|
Nervous system disorders
Dysphasia
|
9.1%
1/11 • 1 year
|
|
Gastrointestinal disorders
Esophageal ulcer
|
9.1%
1/11 • 1 year
|
|
General disorders
Gen disorders & admin site conditions Other, spec
|
9.1%
1/11 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.1%
1/11 • 1 year
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • 1 year
|
|
Cardiac disorders
Heart failure
|
9.1%
1/11 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
1/11 • 1 year
|
|
General disorders
Irritability
|
9.1%
1/11 • 1 year
|
|
Nervous system disorders
Memory impairment
|
9.1%
1/11 • 1 year
|
|
Infections and infestations
Mucosal infection
|
9.1%
1/11 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
1/11 • 1 year
|
|
Gastrointestinal disorders
Oral pain
|
9.1%
1/11 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
1/11 • 1 year
|
|
Investigations
Urine output decreased
|
9.1%
1/11 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
9.1%
1/11 • 1 year
|
Additional Information
Sergio Giralt, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-6009
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place