Trial Outcomes & Findings for Testing Sunitinib as Potentially Targeted Treatment in Cancers With cKIT Genetic Changes (MATCH - Subprotocol V) (NCT NCT06390826)

Last Updated: 2025-11-17

Results Overview

ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.\* For treatments given in 21 day (3 week) cycles: every 3 cycles (9 weeks) for the first 33 cycles, and every 4 cycles thereafter (12 weeks) * For treatments given in 28 day (4 week) cycles: every 2 cycles (8 weeks) for the first 26 cycles, and every three cycles thereafter (12 weeks) * For treatments given in 42 day (6 week) cycles: every 2 cycles (12 weeks)

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Tumor assessments occurred at baseline, then every 3 months if patient is < 2 years from study entry, and every 6 months thereafter until disease progression, up to 3 years post registration

Results posted on

2025-11-17

Participant Flow

Subprotocol V was activated on August 12, 2015. A total of 10 patients were enrolled between November 1, 2016 and May 21, 2020. Four patients were enrolled on the basis of the results from the NCI-MATCH assay and 6 on the basis of the outside assay results.

Eligible patients for arm-V must have a somatic cKIT mutation in exon 9, 11, 13 or 14, excluding exon 17 or 18 mutations, activating PDGFRA or PDGFRB variants and fusions, or another aberration as identified in the protocol. The mutation status was determined by an NCI-MATCH approved laboratory for 6 patients in this arm, these cases had to be confirmed to be used in primary analysis.

Participant milestones

Participant milestones
Measure	Treatment (Sunitinib) Patients receive sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Overall Study STARTED	10
Overall Study Started Protocol Therapy	9
Overall Study Eligible, Treated and Mutation Status Confirmed	9
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Sunitinib) Patients receive sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Overall Study Never Start Protocol Therapy	1
Overall Study Adverse Event	1
Overall Study Disease Progression	8

Baseline Characteristics

Testing Sunitinib as Potentially Targeted Treatment in Cancers With cKIT Genetic Changes (MATCH - Subprotocol V)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Sunitinib) n=9 Participants Patients receive sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Age, Continuous	62 years n=202 Participants
Sex: Female, Male Female	5 Participants n=202 Participants
Sex: Female, Male Male	4 Participants n=202 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=202 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=202 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=202 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=202 Participants
Race (NIH/OMB) Asian	1 Participants n=202 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants
Race (NIH/OMB) Black or African American	0 Participants n=202 Participants
Race (NIH/OMB) White	7 Participants n=202 Participants
Race (NIH/OMB) More than one race	0 Participants n=202 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=202 Participants

PRIMARY outcome

Timeframe: Tumor assessments occurred at baseline, then every 3 months if patient is < 2 years from study entry, and every 6 months thereafter until disease progression, up to 3 years post registration

Population: Patients who were eligible, started protocol therapy, and had mutation status confirmed at the analysis time were the analyzable patients

Outcome measures

Outcome measures
Measure	Treatment (Sunitinib) n=9 Participants Patients receive sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Objective Response Rate (ORR)	22.2 percentage of participants Interval 4.1 to 55.0

SECONDARY outcome

Population: Patients who were eligible, started protocol therapy, and had mutation status confirmed at the analysis time were the analyzable patients

Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.

Outcome measures

Outcome measures
Measure	Treatment (Sunitinib) n=9 Participants Patients receive sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
6-month Progression Free Survival (PFS)	33.3 percentage of participants Interval 15.4 to 72.4

SECONDARY outcome

Population: Patients who were eligible, started protocol therapy, and had mutation status confirmed at the analysis time were the analyzable patients

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.

Outcome measures

Outcome measures
Measure	Treatment (Sunitinib) n=9 Participants Patients receive sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Progression Free Survival	4.2 months Interval 2.9 to 8.5

Adverse Events

Treatment (Sunitinib)

Serious events: 5 serious events

Other events: 6 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Sunitinib) n=9 participants at risk Patients receive sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
General disorders Fatigue	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations Lymphocyte count decreased	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations Neutrophil count decreased	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations Platelet count decreased	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations White blood cell decreased	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Renal and urinary disorders Proteinuria	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Vascular disorders Hypertension	44.4% 4/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Vascular disorders Thromboembolic event	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).

Other adverse events

Other adverse events
Measure	Treatment (Sunitinib) n=9 participants at risk Patients receive sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Blood and lymphatic system disorders Anemia	33.3% 3/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Cardiac disorders Palpitations	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Cardiac disorders Sinus tachycardia	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
General disorders Chills	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
General disorders Edema face	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
General disorders Edema limbs	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
General disorders Fatigue	55.6% 5/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
General disorders Fever	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
General disorders Localized edema	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
General disorders Pain	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Skin and subcutaneous tissue disorders Alopecia	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Skin and subcutaneous tissue disorders Dry skin	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Skin and subcutaneous tissue disorders Pruritus	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Skin and subcutaneous tissue disorders Rash acneiform	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Skin and subcutaneous tissue disorders Rash maculo-papular	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Skin and subcutaneous tissue disorders Skin ulceration	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Endocrine disorders Hyperthyroidism	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Endocrine disorders Hypothyroidism	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Cheilitis	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Constipation	33.3% 3/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Diarrhea	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Dry mouth	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Dyspepsia	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Gastroesophageal reflux disease	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Mucositis oral	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Nausea	33.3% 3/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Oral pain	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Periodontal disease	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Rectal hemorrhage	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Gastrointestinal disorders Vomiting	33.3% 3/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations Alanine aminotransferase increased	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations Aspartate aminotransferase increased	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations Blood bilirubin increased	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations Creatinine increased	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations Lymphocyte count decreased	33.3% 3/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations Neutrophil count decreased	44.4% 4/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations Platelet count decreased	55.6% 5/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations White blood cell decreased	44.4% 4/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Investigations Investigations - Other, specify	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Metabolism and nutrition disorders Anorexia	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Metabolism and nutrition disorders Hypernatremia	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Metabolism and nutrition disorders Hypoalbuminemia	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Metabolism and nutrition disorders Hypocalcemia	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Metabolism and nutrition disorders Hypomagnesemia	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Metabolism and nutrition disorders Hyponatremia	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Metabolism and nutrition disorders Hypophosphatemia	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Musculoskeletal and connective tissue disorders Bone pain	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Nervous system disorders Dizziness	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Nervous system disorders Dysgeusia	33.3% 3/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Nervous system disorders Headache	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Nervous system disorders Paresthesia	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Eye disorders Dry eye	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Eye disorders Watering eyes	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Eye disorders Eye disorders - Other, specify	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Respiratory, thoracic and mediastinal disorders Epistaxis	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Respiratory, thoracic and mediastinal disorders Sore throat	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Renal and urinary disorders Hematuria	22.2% 2/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Renal and urinary disorders Proteinuria	44.4% 4/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Reproductive system and breast disorders Irregular menstruation	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Vascular disorders Flushing	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Vascular disorders Hot flashes	11.1% 1/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
Vascular disorders Hypertension	55.6% 5/9 • Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).

Additional Information

Study Statistician

ECOG-ACRIN Cancer Research Group

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60