Trial Outcomes & Findings for Cabozantinib in Men With Castration-Resistant Prostate Cancer (NCT NCT01703065)

NCT ID: NCT01703065

Last Updated: 2018-12-04

Results Overview

Median percent change in Urinary N-Telopeptide from baseline compared to after 6 weeks of treatment with Cabozantinib in patients with non-metastatic prostate cancer.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: Baseline and 6 weeks
• Results posted on: 2018-12-04

Participant Flow

Participant milestones

Measure	Cabozantinib in Metastatic CRPC Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day	Cabozantinib in Non-metastatic CRPC Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day
Overall Study STARTED	9	0
Overall Study COMPLETED	8	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Cabozantinib in Metastatic CRPC Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day	Cabozantinib in Non-metastatic CRPC Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day
Overall Study Lack of Efficacy	1	0

Baseline Characteristics

Cabozantinib in Men With Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Measure	Cabozantinib in Metastatic CRPC n=9 Participants Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day	Cabozantinib in Non-metastatic CRPC Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	—	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	—	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	—	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: Of 9 total patients enrolled, 0 had non-metastatic CRPC, therefore this outcome was not analyzed.

Median percent change in Urinary N-Telopeptide from baseline compared to after 6 weeks of treatment with Cabozantinib in patients with non-metastatic prostate cancer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and at 6 weeks

Population: Bone Specific Alkaline Phosphate was analyzed in blood samples from 8 patients with metastatic CRPC at baseline and following 6 weeks of treatment. 1 participant did not provide a 6 week sample, and was therefore excluded from this analysis. 0 participants were enrolled in the non-metastatic CRPC arm.

Median percent change in Bone Specific Alkaline Phosphatase from baseline compared to after 6 weeks of treatment with Cabozantinib.

Outcome measures

Measure	Cabozantinib in Non-metastatic CRPC n=8 Participants Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day	Cabozantinib in Non-metastatic CRPC Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day
Change in Bone Specific Alkaline Phosphatase as a Marker of Bone Metabolism	42.83 percent change Interval -45.1 to 269.23	—

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: Alkaline Phosphatase was analyzed in blood samples from 7 patients with metastatic CRPC at baseline and following 6 weeks of treatment. 2 participants did not provide a 6 week sample and were therefore excluded from this analysis. 0 participants were enrolled in the non-metastatic CRPC arm.

Median percent change in Alkaline Phosphatase from baseline compared to after 6 weeks of treatment with Cabozantinib.

Outcome measures

Measure	Cabozantinib in Non-metastatic CRPC n=7 Participants Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day	Cabozantinib in Non-metastatic CRPC Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day
Change in Alkaline Phosphatase as a Marker of Bone Metabolism	23.88 percent change Interval -28.92 to 272.09	—

SECONDARY outcome

Timeframe: Baseline and at 6 weeks

Population: Lactic Acid Dehydrogenase (LDH) was analyzed in blood samples from 8 patients with metastatic CRPC at baseline and following 6 weeks of treatment. 1 participant did not provide a 6 week sample and was therefore excluded from this analysis. 0 participants were enrolled in the non-metastatic CRPC arm.

Median percent change in Lactic Acid Dehydrogenase (LDH) from baseline compared to after 6 weeks of treatment with Cabozantinib.

Outcome measures

Measure	Cabozantinib in Non-metastatic CRPC n=8 Participants Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day	Cabozantinib in Non-metastatic CRPC Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day
Change in Lactic Acid Dehydrogenase (LDH) as a Marker of Bone Metabolism	65.27 percent change Interval 12.59 to 120.07	—

SECONDARY outcome

Timeframe: Baseline and at 6 weeks

Population: No nmCRCP patients enrolled, so no bone samples analyzed for this cohort. The purpose of biopsies in mCRPC cohort was to compare with those in nmCRPC cohort. Since no data to compare to, bone biopsy samples obtained were not analyzed. Only 1 patient with day 43 biopsy had specimen collected in both formalin and ethanol at baseline.

To include MET, AKT, FASN and VEGFR2 expression and phosphorylation status (activation) in osteoblasts/osteoclasts and prostate cancer cells. Will also include changes in markers of apoptosis, proliferation, and angiogenesis.

Outcome measures

Outcome data not reported

Adverse Events

Cabozantinib in Metastatic CRPC

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Cabozantinib in Non-metastatic CRPC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cabozantinib in Metastatic CRPC n=9 participants at risk Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day	Cabozantinib in Non-metastatic CRPC Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day
Metabolism and nutrition disorders Dehydration	11.1% 1/9 • Number of events 1 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Vascular disorders Orthostatic Hypotension	11.1% 1/9 • Number of events 1 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Refractory MultiFocal Pain	11.1% 1/9 • Number of events 1 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.

Other adverse events

Measure	Cabozantinib in Metastatic CRPC n=9 participants at risk Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day	Cabozantinib in Non-metastatic CRPC Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given orally once a day
General disorders Fatigue	100.0% 9/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Nausea	100.0% 9/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Dizziness	33.3% 3/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Injury, poisoning and procedural complications Left hip pain	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Hypophosphatemia	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Dehydration	44.4% 4/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Musculoskeletal and connective tissue disorders Low back pain increased	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Musculoskeletal and connective tissue disorders Right shoulder pain - muscle	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Dry mouth	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Renal and urinary disorders Dark colored urine	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Abdominal pain	44.4% 4/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Vomiting	55.6% 5/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Anorexia	88.9% 8/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Blood and lymphatic system disorders Thrombocytopenia	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Hypokalemia	33.3% 3/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Nervous system disorders Right hand neuropathy	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Constipation	33.3% 3/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Weight loss	44.4% 4/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Cardiac disorders Hypertension	55.6% 5/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Mouth sore	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Gastroesophageal reflux	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Chest pain, non-cardiac	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Laringeal inflammation	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Fever	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Sacral pain	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Hepatobiliary disorders ALT increased	44.4% 4/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Hepatobiliary disorders AST increased	55.6% 5/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Dysgeusia	44.4% 4/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Musculoskeletal and connective tissue disorders Polyartralgia	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Flu-like symptoms	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Hemorrhoidal bleeding	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Musculoskeletal and connective tissue disorders Right hip pain	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Musculoskeletal and connective tissue disorders Bilateral leg pain	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Respiratory, thoracic and mediastinal disorders Pneumonia	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Musculoskeletal and connective tissue disorders Pelvis pain	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Skin and subcutaneous tissue disorders Seborrheic dermatitis, right ear	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Endocrine disorders Elevated TSH	33.3% 3/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Skin and subcutaneous tissue disorders Rash, right groin	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Musculoskeletal and connective tissue disorders Right scapular pain	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Weakness	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Headache	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Insomnia	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Night sweats	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Cardiac disorders Tachycardia	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Heart burn	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Hoarseness	33.3% 3/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Loose stools	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders GERD	44.4% 4/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Musculoskeletal and connective tissue disorders Cervical and lumbar spine pain	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Musculoskeletal and connective tissue disorders Left heel pain	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Musculoskeletal and connective tissue disorders Muscle cramp	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Vascular disorders Telangiectasia cheeks	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Skin and subcutaneous tissue disorders Hyperpigmented papules	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Diarrhea	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Skin and subcutaneous tissue disorders Dry skin	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Hand-Foot syndrome	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Mucositis	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Runny nose	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Blood and lymphatic system disorders Neutropenia	22.2% 2/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Body aches	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Blood and lymphatic system disorders increased triglycerides	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Right upper arm bruising	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Blood and lymphatic system disorders Leukopenia	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Renal and urinary disorders Hematuria	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Musculoskeletal and connective tissue disorders Bilateral knee pain	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Nervous system disorders Neuropathy	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
Gastrointestinal disorders Dry heaving	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Hypercalcemia	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.
General disorders Pharingitis	11.1% 1/9 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.	— 0/0 • Adverse event data were collected for each patient from first dose of study treatment through 30 days after the last dose of study treatment. Adverse events were recorded for patients in the metastatic arm. There were no patients enrolled in the non-metastatic arm.

Additional Information

Dr. Celestia Higano, MD

University of Washington

Phone: 206-606-1152

Email: thigano@u.washington.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place