Trial Outcomes & Findings for NaF Positron Emission Tomography/Computed Tomography (PET/CT)Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastasis (NCT NCT01816048)

NCT ID: NCT01816048

Last Updated: 2019-12-09

Results Overview

To measure changes in NaF PET/CT standardized uptake values (SUVmax) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Value at three months minus value at baseline.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: Baseline and 3 months
• Results posted on: 2019-12-09

Participant Flow

Participant milestones

Measure	TAK-700 TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Overall Study STARTED	8
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	TAK-700 TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Overall Study Adverse Event	1
Overall Study Death	1
Overall Study Withdrawal by Subject	1
Overall Study Disease Progression	3

Baseline Characteristics

NaF Positron Emission Tomography/Computed Tomography (PET/CT)Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastasis

Baseline characteristics by cohort

Measure	TAK-700 n=8 Participants TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 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
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan.

To measure changes in NaF PET/CT standardized uptake values (SUVmax) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Value at three months minus value at baseline.

Outcome measures

Measure	TAK-700 n=4 Participants TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values SUVmax decrease	3 Participants
Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values SUVmax increase	1 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: Study closed early and only 8 of planned 20 enrolled. Four subjects came off study prior to the three month time point.

Measure prostate specific antigen (PSA) response rate in patients treated with TAK700, as measured by a decline in the PSA level from baseline to the month 3 assessment according to the Prostate Cancer Clinical Trials Working Group (PCWG2), at least a 50% decrease from baseline. Percent increase or decrease from month three compared to baseline.

Outcome measures

Measure	TAK-700 n=4 Participants TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate PSA decline >= 50%	3 Participants
Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate PSA decline =< 50%	1 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan.

To measure changes in NaF PET/CT standardized uptake values (SUV total) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Percent change from three months to baseline; value at three months minus value at baseline.

Outcome measures

Measure	TAK-700 n=4 Participants TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values SUV total increase	1 Participants
Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values SUV total decrease	2 Participants
Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values SUV total no change	1 Participants

SECONDARY outcome

Timeframe: Up to 12 months

The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment.

Outcome measures

Measure	TAK-700 n=8 Participants TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700	8 participants

SECONDARY outcome

Timeframe: Up to 14 months

Population: Due to study closing early only 8 of planned 20 patients enrolled.

Stable: no change in PSA kinetics Decrease: less than baseline Increase: greater than baseline

PSA data was gathered at baseline and off treatment.

Outcome measures

Measure	TAK-700 n=8 Participants TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment Stable	1 Participants
Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment Decrease in PSA	3 Participants
Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment Increase in PSA	4 Participants

SECONDARY outcome

Timeframe: At baseline and 12 weeks

Population: Due to study closing early only 8 of planned 20 patients enrolled and only 4 of the 8 subjects enrolled completed the week 12 scan.

This is an exploratory endpoint as we are planning to identify other new parameters during the PET/CT scanning that may be more predictive of response (such as SUV volume, or dynamic changes during the scanning period). Changes in results at week 12 compared to baseline. Value at 12 weeks minus value at baseline.

Outcome measures

Measure	TAK-700 n=4 Participants TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Number of Participants With Changes in NaF PET/CT Results in Response to TAK700 Increase in SUV total	1 Participants
Number of Participants With Changes in NaF PET/CT Results in Response to TAK700 No change	1 Participants
Number of Participants With Changes in NaF PET/CT Results in Response to TAK700 Decrease in SUV total	2 Participants

SECONDARY outcome

Timeframe: Approximately 24 months

Population: Due to study closing early, only 8 of planned 20 patients enrolled. Data for this endpoint was not obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and 12 weeks

Population: Due to study closing early only 8 of 12 patients enrolled, and only 5 subjects obtained a week 12 CTC test.

Baseline compared to 12 weeks. Value at three months minus value at baseline.

Outcome measures

Measure	TAK-700 n=5 Participants TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot) Increase in circulating tumors	2 Participants
Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot) Decrease in circulating tumors	3 Participants

SECONDARY outcome

Timeframe: At baseline, one month, three months

Population: Due to study closing early only 8 of planned 20 enrolled. All subjects completed one month of treatment; only 4 subjects completed the week 12 scan.

Change from baseline to one month and three month.

Outcome measures

Measure	TAK-700 n=8 Participants TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles Cycle 1 (one month) · Decrease in circulating tumors	5 Participants
Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles Cycle 1 (one month) · No change	1 Participants
Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles Cycle 4 (three months) · Increase in circulating tumors	1 Participants
Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles Cycle 4 (three months) · Decrease in circulating tumors	1 Participants
Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles Cycle 4 (three months) · No change	2 Participants
Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles Cycle 1 (one month) · Increase in circulating tumors	2 Participants

SECONDARY outcome

Timeframe: Baseline, one month, 2 months, 3 months

Population: Data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

TAK-700

Serious events: 4 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Measure	TAK-700 n=8 participants at risk TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Gastrointestinal disorders Dehydration	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Gastrointestinal disorders Diarrhea	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Metabolism and nutrition disorders Hypokalemia	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Cardiac disorders Left ventricular systolic dysfunction	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Nervous system disorders Nerve impingement	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
General disorders sudden death	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.

Other adverse events

Measure	TAK-700 n=8 participants at risk TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan
Gastrointestinal disorders Abdominal pain	25.0% 2/8 • Number of events 2 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Immune system disorders Allergic rhinitis	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Gastrointestinal disorders Anorexia	62.5% 5/8 • Number of events 6 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Psychiatric disorders Anxiety	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Musculoskeletal and connective tissue disorders Back pain	50.0% 4/8 • Number of events 6 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Gastrointestinal disorders Bloating	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Gastrointestinal disorders Constipation	25.0% 2/8 • Number of events 3 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Metabolism and nutrition disorders Dehydration	25.0% 2/8 • Number of events 3 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Psychiatric disorders Depression	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Gastrointestinal disorders Diarrhea	25.0% 2/8 • Number of events 4 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Renal and urinary disorders Disuria	25.0% 2/8 • Number of events 2 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Gastrointestinal disorders Dry mouth	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Skin and subcutaneous tissue disorders Dry skin	25.0% 2/8 • Number of events 2 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
General disorders Edema limbs	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Investigations Ejection fraction decreased	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
General disorders Fatigue	50.0% 4/8 • Number of events 4 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
General disorders Fever	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	25.0% 2/8 • Number of events 2 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Nervous system disorders Headache	50.0% 4/8 • Number of events 6 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Respiratory, thoracic and mediastinal disorders Hoarseness	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Vascular disorders Hot flashes	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Vascular disorders Hypertension	37.5% 3/8 • Number of events 3 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Metabolism and nutrition disorders Hypokalemia	50.0% 4/8 • Number of events 7 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Metabolism and nutrition disorders Hypomagnesemia	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Injury, poisoning and procedural complications Injury, arm	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Psychiatric disorders Insomnia	37.5% 3/8 • Number of events 3 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Respiratory, thoracic and mediastinal disorders Nasal congestion	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Gastrointestinal disorders Nausea	87.5% 7/8 • Number of events 14 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
General disorders Pain	37.5% 3/8 • Number of events 8 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Gastrointestinal disorders Pancreatitis	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Nervous system disorders Peripheral sensory neuropathy	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Respiratory, thoracic and mediastinal disorders Productive cough	25.0% 2/8 • Number of events 2 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Renal and urinary disorders Renal calculi	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Infections and infestations Rhinitis infective	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Infections and infestations Sinusitis	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasms benigh, malignant and unspecified	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Gastrointestinal disorders Stomach pain	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Renal and urinary disorders Urinary frequency	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Renal and urinary disorders Urinary incontinence	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Renal and urinary disorders Urinary tract infection	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Gastrointestinal disorders Vomiting	25.0% 2/8 • Number of events 2 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Investigations Weight loss	37.5% 3/8 • Number of events 3 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
Nervous system disorders nerve impingement	12.5% 1/8 • Number of events 1 • 1 year, 11 months All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.

Additional Information

Dr. Justine Bruce

University of Wisconsin Carbone Cancer Center

Phone: 608-262-4961

Email: jybruce@medicine.wisc.edu

Results disclosure agreements

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