Trial Outcomes & Findings for RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer (NCT NCT01217411)
NCT ID: NCT01217411
Last Updated: 2024-11-19
Results Overview
Maximum-tolerated dose (MTD) of RO4929097 in combination with WBRT, determined according to incidence of dose limiting toxicity (DLT) graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
4 weeks
Results posted on
2024-11-19
Participant Flow
Recruitment Period: October 1, 2010 to December 21, 2011. All recruitment was done in a medical clinic setting.
Study terminated early due to low accrual and discontinuation of investigational study drug.
Participant milestones
| Measure |
Phase 1 Arm I (WBRT + R04929097)
Patients with \>= 4 brain lesions undergo WBRT + R04929097
Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery
|
Phase 1 Arm II (SRS + RO4929097)
Patients with =\< 3 brain lesions receive RO4929097 and undergo SRS. For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.
Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors \>2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
5mg
|
3
|
2
|
|
Overall Study
10mg
|
0
|
0
|
|
Overall Study
20mg
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 Arm I (WBRT + R04929097)
n=3 Participants
Patients with \>= 4 brain lesions undergo WBRT + R04929097 Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery
|
Phase 1 Arm II (SRS + RO4929097)
n=2 Participants
Patients with =\< 3 brain lesions receive RO4929097 and undergo SRS. For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.
Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors \>2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
49 years
n=7 Participants
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Analysis was not available due to small number of patients on the study.
Maximum-tolerated dose (MTD) of RO4929097 in combination with WBRT, determined according to incidence of dose limiting toxicity (DLT) graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 weeksPopulation: Analysis was not available due to small number of patients on the study.
MTD of RO4929097 in combination with SRS, determined according to incidence of DLT graded using the NCI CTCAE version 4.0 (phase I)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 weeksOnly participants with measurable disease present at baseline, received at least 6 weeks of therapy, and had disease re-evaluated considered evaluable for response. Complete Response (CR): Disappearance all lesions; Partial Response (PR): =/\>50% decrease in sum bidimensional products all lesions reference baseline sum of bidimensional products of all lesions; Progressive Disease (PD): \>25% increase in sum bidimensional products of lesions, or progression of any treated lesion not target lesion, or appearance of 1 or \> new lesions at least 6 mm in unidimensional size. Stable Disease (SD): Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum of bidimensional products of all lesions.
Outcome measures
| Measure |
Phase 1 Arm I
n=3 Participants
RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg
For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097\*\* (3 days on/4 days off continuous) 1 day prior to beginning WBRT
|
Phase 1 Arm II
n=2 Participants
Arm 2: Patients with less than 4 lesions will receive Stereotactic Radiosurgery (SRS) combined with R04929097 (study drug). 1st cohort: starting dose of 5mg (2nd cohort 10mg, 3rd cohort 20 mg) (3 days on/4 days off continuous) 3 days prior to SRS)
|
|---|---|---|
|
Response Rate (Complete or Partial Response)
|
3 Participants
|
2 Participants
|
Adverse Events
Phase 1 Arm I (WBRT + R04929097)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Arm II (SRS + RO4929097)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Arm I (WBRT + R04929097)
n=3 participants at risk
RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg
For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097\*\* (3 days on/4 days off continuous) 1 day prior to beginning WBRT
For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097\*\* (3 days on/ 4 days off continuous) 2 days prior to SRS
|
Phase 1 Arm II (SRS + RO4929097)
n=2 participants at risk
Patients with =\< 3 brain lesions receive RO4929097 and undergo SRS. For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.
Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors \>2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality
|
|---|---|---|
|
Cardiac disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
General disorders
Death NOS
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
33.3%
1/3 • Number of events 2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Cardiac disorders
Ventricular tachycardia
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
Other adverse events
| Measure |
Phase 1 Arm I (WBRT + R04929097)
n=3 participants at risk
RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg
For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097\*\* (3 days on/4 days off continuous) 1 day prior to beginning WBRT
For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097\*\* (3 days on/ 4 days off continuous) 2 days prior to SRS
|
Phase 1 Arm II (SRS + RO4929097)
n=2 participants at risk
Patients with =\< 3 brain lesions receive RO4929097 and undergo SRS. For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.
Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors \>2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality
|
|---|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
2/3 • Number of events 2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 4 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Cardiac disorders
Sinus Bradycardia
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 4 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 4 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
3/3 • Number of events 4 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 5 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 5 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
33.3%
1/3 • Number of events 2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Vascular disorders
Hypotension
|
66.7%
2/3 • Number of events 2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Investigations
Investigations
|
100.0%
3/3 • Number of events 9 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
100.0%
2/2 • Number of events 8 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Musculoskeletal and connective tissue disorders
Muscle Wasting
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Musculoskeletal and connective tissue disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Psychiatric disorders
Syncope
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Nervous system disorders
Seizure
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Skin and subcutaneous tissue disorders
Darkness skin
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
33.3%
1/3 • Number of events 2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
50.0%
1/2 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
0.00%
0/2 • Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Study did not progress to Phase II so two arms of second phase excluded from AE reporting table.
|
Additional Information
Morris D. Groves, MD / Professor
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-2573
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60