Trial Outcomes & Findings for Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors (NCT NCT04056910)

Last Updated: 2025-02-27

Results Overview

Number of patients with Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm, Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters per RECIST v1.1 Criteria, or, per RANO Criteria: Complete Response (CR): Observed in consecutive assessments ≥4 weeks apart per RANO. Partial Response (PR): Observed in consecutive assessments ≥4 weeks apart per RANO.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

At 8 weeks after first treatment; up to 14 months for cohort

Results posted on

2025-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Concurrent Dosing of Ivosidenib and Nivolumab Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule. ivosidenib and nivolumab: Ivosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events. Nivolumab will be administered at 480 mg IV every 28 days.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Concurrent Dosing of Ivosidenib and Nivolumab n=15 Participants Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule. ivosidenib and nivolumab: Ivosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events. Nivolumab will be administered at 480 mg IV every 28 days.
Age, Continuous	56.13 years STANDARD_DEVIATION 12.82 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 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	1 Participants n=5 Participants
Race (NIH/OMB) White	14 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
ECOG Performance Score ECOG Performance Score = 0	6 Participants n=5 Participants
ECOG Performance Score ECOG Performance Score = 1	9 Participants n=5 Participants
Disease Site BILE DUCT - INTRAHEPATIC	1 Participants n=5 Participants
Disease Site BILIARY TRACT - NOS	1 Participants n=5 Participants
Disease Site BONES - NOS	1 Participants n=5 Participants
Disease Site BONES - RIB STER CLAV & ASS JTS	1 Participants n=5 Participants
Disease Site BRAIN - FRONTAL LOBE	1 Participants n=5 Participants
Disease Site BRAIN - NOS	5 Participants n=5 Participants
Disease Site BRAIN - PARIETAL LOBE	1 Participants n=5 Participants
Disease Site COLON - DESCENDING	1 Participants n=5 Participants
Disease Site GALLBLADDER	2 Participants n=5 Participants
Disease Site SKIN - UPPER LIMB AND SHOULDER	1 Participants n=5 Participants
Histology ADENOCARCINOMA, N/A	1 Participants n=5 Participants
Histology ASTROCYTOMA, ANAPLASTIC	1 Participants n=5 Participants
Histology ASTROCYTOMA, NOS	2 Participants n=5 Participants
Histology CARCINOMA, METASTATIC, NOS	1 Participants n=5 Participants
Histology CHOLANGIOCARCINOMA	2 Participants n=5 Participants
Histology CHONDROSARCOMA, NOS	1 Participants n=5 Participants
Histology CHONDROSARCOMA, NOS, MAL, MET	1 Participants n=5 Participants
Histology GLIOBLASTOMA, NOS	1 Participants n=5 Participants
Histology NEOPLASM, MALIGNANT	2 Participants n=5 Participants
Histology OLIGODENDROGLIOMA, ANAPLASTIC	2 Participants n=5 Participants
Histology OLIGODENDROGLIOMA, NOS	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 8 weeks after first treatment; up to 14 months for cohort

Population: Patients who received treatment and were evaluated for radiologic response.

Outcome measures

Outcome measures
Measure	Concurrent Dosing of Ivosidenib and Nivolumab n=7 Participants Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule. ivosidenib and nivolumab: Ivosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events. Nivolumab will be administered at 480 mg IV every 28 days.
Best Overall Response Partial Response (PR)	1 Participants
Best Overall Response Stable Disease (SD)	6 Participants

PRIMARY outcome

Timeframe: At 6 months

Population: Patients who received treatment and were evaluated for radiologic response who did not experience disease progression at the designated time frame.

Percentage of participants surviving without objective tumor progression at six months after the initiation of treatment. Per RECIST v1.1 Criteria: Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. Per RANO Criteria: Progressive Disease: No CR, PR, SD prior to PD. Progression: 25% or more increase in enhancing lesions despite stable or increasing steroid dose, increase (significant) in non-enhancing FLAIR/T2W lesions, not attributable to other non-tumor causes, any new lesions; clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease)

Outcome measures

Outcome measures
Measure	Concurrent Dosing of Ivosidenib and Nivolumab n=15 Participants Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule. ivosidenib and nivolumab: Ivosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events. Nivolumab will be administered at 480 mg IV every 28 days.
Six Month Progression-Free Survival (PFS6)	20 percentage of participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients assessed for Dose Limiting Toxicities.

The occurrence (number) of dose limiting toxicity (DLT) in patients receiving ivosidenib plus nivolumab. DLT describes side effects of the treatment that are serious enough to prevent an increase in dose or level of that treatment. CTCAE v5 was used to assess Adverse Events and Serious Adverse Events.

Outcome measures

Outcome measures
Measure	Concurrent Dosing of Ivosidenib and Nivolumab n=15 Participants Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule. ivosidenib and nivolumab: Ivosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events. Nivolumab will be administered at 480 mg IV every 28 days.
Occurrence of Dose Limiting Toxicity (DLT)	0 Participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: Patients who experienced a treated-related adverse event.

Number of patients who experienced Adverse Events or Serious Adverse Events per NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0), that were related to their receiving the treatment combination of ivosidenib and nivolumab.

Outcome measures

Outcome measures
Measure	Concurrent Dosing of Ivosidenib and Nivolumab n=13 Participants Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule. ivosidenib and nivolumab: Ivosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events. Nivolumab will be administered at 480 mg IV every 28 days.
Adverse Events Related to Treatment Hip pain	1 Participants
Adverse Events Related to Treatment Muscle cramps- intermittent	1 Participants
Adverse Events Related to Treatment Rash	1 Participants
Adverse Events Related to Treatment Hyperthyroidism	1 Participants
Adverse Events Related to Treatment Anemia	2 Participants
Adverse Events Related to Treatment Eosinophilia	1 Participants
Adverse Events Related to Treatment Vomiting	2 Participants
Adverse Events Related to Treatment Fatigue	1 Participants
Adverse Events Related to Treatment Flu like symptoms	1 Participants
Adverse Events Related to Treatment Blood bilirubin increased	1 Participants
Adverse Events Related to Treatment Lymphocyte count decreased	2 Participants
Adverse Events Related to Treatment Neutrophil count decreased	2 Participants
Adverse Events Related to Treatment QTC prolongation	2 Participants
Adverse Events Related to Treatment Thyroid Stimulating Hormone Increased	3 Participants
Adverse Events Related to Treatment Hypothyroidism	4 Participants
Adverse Events Related to Treatment Diarrhea	4 Participants
Adverse Events Related to Treatment Nausea	1 Participants
Adverse Events Related to Treatment Weight loss	1 Participants
Adverse Events Related to Treatment Infusion related reaction	2 Participants
Adverse Events Related to Treatment Alanine aminotransferase increased	1 Participants
Adverse Events Related to Treatment Aspartate aminotransferase increased	1 Participants
Adverse Events Related to Treatment Anorexia	1 Participants
Adverse Events Related to Treatment Arthralgia	1 Participants
Adverse Events Related to Treatment Gait disturbance	1 Participants
Adverse Events Related to Treatment Pruritus	3 Participants
Adverse Events Related to Treatment Rash maculo-papular	9 Participants

SECONDARY outcome

Timeframe: Up to 25 months

Population: Patients who received treatment and were evaluated for radiologic response and who did not experience disease progression during the designated time frame.

The time from first dose of either drug until disease progression or death from any cause, whichever occurs first. RECIST v1.1 Criteria: Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. RANO Criteria: Progressive Disease: No CR, PR, SD prior to PD. Progression: 25% or more increase in enhancing lesions despite stable or increasing steroid dose, increase (significant) in non-enhancing FLAIR/T2W lesions, not attributable to other non-tumor causes, any new lesions; clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease)

Outcome measures

Outcome measures
Measure	Concurrent Dosing of Ivosidenib and Nivolumab n=15 Participants Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule. ivosidenib and nivolumab: Ivosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events. Nivolumab will be administered at 480 mg IV every 28 days.
Progression Free Survival (PFS)	1.94 months Interval 1.61 to 3.68

Adverse Events

Concurrent Dosing of Ivosidenib and Nivolumab

Serious events: 4 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Concurrent Dosing of Ivosidenib and Nivolumab n=15 participants at risk Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule. ivosidenib and nivolumab: Ivosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events. Nivolumab will be administered at 480 mg IV every 28 days.
Cardiac disorders Atrial fibrillation	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Cardiac disorders Sinus tachycardia	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Endocrine disorders Hyperthyroidism	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Eye disorders Flashing lights	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Infections and infestations Catheter related infection	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Infections and infestations Sepsis	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Nervous system disorders Headache	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)

Other adverse events

Other adverse events
Measure	Concurrent Dosing of Ivosidenib and Nivolumab n=15 participants at risk Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule. ivosidenib and nivolumab: Ivosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events. Nivolumab will be administered at 480 mg IV every 28 days.
Psychiatric disorders Panic Attacks (Intermittent)	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Renal and urinary disorders Chronic kidney disease	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Renal and urinary disorders Proteinuria	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Renal and urinary disorders Nocturnal enuresis	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Blood and lymphatic system disorders Anemia	46.7% 7/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Blood and lymphatic system disorders Eosinophilia	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Cardiac disorders Coronary artery disease	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Cardiac disorders QTC prolongation	26.7% 4/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Cardiac disorders Sinus tachycardia	20.0% 3/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Endocrine disorders Thyroid Stimulating Hormone Increased	33.3% 5/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Endocrine disorders Hyperthyroidism	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Endocrine disorders Hypothyroidism	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Eye disorders Double Vision - Intermittent	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Gastrointestinal disorders Ascites	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Gastrointestinal disorders Bloating	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Gastrointestinal disorders Constipation	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Gastrointestinal disorders Diarrhea	53.3% 8/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Gastrointestinal disorders Gastroesophageal reflux disease	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Gastrointestinal disorders Nausea	33.3% 5/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Gastrointestinal disorders Vomiting	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
General disorders Fatigue	46.7% 7/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
General disorders Fever	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
General disorders Flu like symptoms	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
General disorders Gait disturbance	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
General disorders Ascites	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
General disorders Weight loss	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
General disorders Infusion related reaction	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
General disorders Localized edema	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
General disorders Pain	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Infections and infestations Sinusitis	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Infections and infestations Wound infection	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Activated partial thromboplastin time prolonged	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Alanine aminotransferase increased	20.0% 3/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Alkaline phosphatase increased	26.7% 4/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Aspartate aminotransferase increased	20.0% 3/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Blood bilirubin increased	20.0% 3/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Creatinine increased	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Blood Lactate Dehydrogenase Increased	53.3% 8/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Blood Lactate Dehydrogenase Increased (intermittent)	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Lymphocyte count decreased	46.7% 7/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Neutrophil count decreased	40.0% 6/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Platelet count decreased	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Weight gain	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations Weight loss	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Investigations White blood cell decreased	26.7% 4/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Anorexia	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hypercalcemia	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hyperglycemia	26.7% 4/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hyperkalemia	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hyperuricemia	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hypoalbuminemia	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hypocalcemia	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hypoglycemia	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hypokalemia	20.0% 3/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hypomagnesemia	20.0% 3/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hyponatremia	40.0% 6/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hypophosphatemia	33.3% 5/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Metabolism and nutrition disorders Hyperphosphatemia	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Musculoskeletal and connective tissue disorders Arthralgia	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Musculoskeletal and connective tissue disorders Back pain	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Musculoskeletal and connective tissue disorders Gait disturbance	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Musculoskeletal and connective tissue disorders Hip pain	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Musculoskeletal and connective tissue disorders Left Calf Pain	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Musculoskeletal and connective tissue disorders Muscle cramps- intermittent	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Nervous system disorders Dizziness	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Nervous system disorders Headache	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Nervous system disorders Memory impairment	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Nervous system disorders Dizziness - Intermittent	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Nervous system disorders Epileptic Aphasia	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Nervous system disorders impaired concentration	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Nervous system disorders impaired short term memory	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Nervous system disorders Nystagmus	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Psychiatric disorders Insomnia	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Renal and urinary disorders UTI	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Renal and urinary disorders Urine discoloration	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Respiratory, thoracic and mediastinal disorders Dyspnea	13.3% 2/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Respiratory, thoracic and mediastinal disorders Sore throat	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Skin and subcutaneous tissue disorders Pruritus	26.7% 4/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Skin and subcutaneous tissue disorders Rash maculo-papular	60.0% 9/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Skin and subcutaneous tissue disorders Excessive Dryness - Feet	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Skin and subcutaneous tissue disorders Rash	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Skin and subcutaneous tissue disorders Rash - Right Hand	6.7% 1/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)
Vascular disorders Hypertension	40.0% 6/15 • All-Cause Mortality - up to 25 months Serious Adverse Events and Adverse Events - up to 24 months (population)

Additional Information

Barbara Stadterman, MPH, CCRP, Clinical Research Manager

UPMC Hillman Cancer Center

Phone: 4126475554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place