Trial Outcomes & Findings for Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1) (NCT NCT06308822)

Last Updated: 2025-09-24

Results Overview

ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable (ie, eligible, treated and PIK3CA mutation status confirmed) 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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Results posted on

2025-09-24

Participant Flow

The study was activated on June 20, 2018. Thirty-five patients were enrolled between August 20, 2018, and April 30, 2019.

The FGFR amplification status was determined by assay performed in a NCI-MATCH approved laboratory for all patients in this arm. Mutation status was confirmed by central MATCH assay for 18 patients.

Participant milestones

Participant milestones
Measure	Treatment (Erdafitinib) Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial.
Overall Study STARTED	35
Overall Study Eligible	34
Overall Study Started Protocol Therapy	34
Overall Study Eligible and Treated	33
Overall Study Mutation Status Confirmed	18
Overall Study Eligible, Treated and Mutation Status Confirmed	18
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Erdafitinib) Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial.
Overall Study Mutation Status Not Confirmed	17
Overall Study Adverse Event	1
Overall Study Death	5
Overall Study Disease progression	8
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	3

Baseline Characteristics

Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Erdafitinib) n=18 Participants Patients receive erdafitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 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	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Population: Eligible, treated and mutation status confirmed

Outcome measures

Outcome measures
Measure	Treatment (Erdafitinib) n=18 Participants Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial.
Objective Response Rate	0 percentage of participants Interval 0.0 to 15.3

SECONDARY outcome

Timeframe: Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined

Population: Eligible, treated and mutation status confirmed

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 (Erdafitinib) n=18 Participants Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial.
6-month Progression-free Survival (PFS) Rate	13.8 percentage of participants Interval 3.3 to 31.6

SECONDARY outcome

Timeframe: Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Population: Eligible, treated and mutation status confirmed

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 (Erdafitinib) n=18 Participants Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial.
Progression Free Survival (PFS)	1.7 months Interval 1.1 to 1.8

Adverse Events

Treatment (Erdafitinib)

Serious events: 13 serious events

Other events: 29 other events

Deaths: 32 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Erdafitinib) n=33 participants at risk Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial.
Blood and lymphatic system disorders Anemia	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Cardiac disorders Atrioventricular block complete	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Cardiac disorders Mobitz (type) II atrioventricular block	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
General disorders Fatigue	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Abdominal pain	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Ascites	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Mucositis oral	9.1% 3/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Nausea	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Vomiting	9.1% 3/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Hepatobiliary disorders Hepatic failure	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Investigations Aspartate aminotransferase increased	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Investigations Blood bilirubin increased	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Investigations Lymphocyte count decreased	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Metabolism and nutrition disorders Hyponatremia	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) -	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Respiratory, thoracic and mediastinal disorders Hypoxia	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Vascular disorders Hypotension	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Vascular disorders Thromboembolic event	3.0% 1/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).

Other adverse events

Other adverse events
Measure	Treatment (Erdafitinib) n=33 participants at risk Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial.
Blood and lymphatic system disorders Anemia	12.1% 4/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
General disorders Fatigue	33.3% 11/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Skin and subcutaneous tissue disorders Alopecia	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Skin and subcutaneous tissue disorders Dry skin	15.2% 5/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Skin and subcutaneous tissue disorders Nail discoloration	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Skin and subcutaneous tissue disorders Nail loss	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Skin and subcutaneous tissue disorders Nail ridging	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Skin and subcutaneous tissue disorders Rash maculo-papular	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Abdominal pain	9.1% 3/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Constipation	9.1% 3/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Diarrhea	24.2% 8/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Dry mouth	45.5% 15/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Mucositis oral	21.2% 7/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Nausea	15.2% 5/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Vomiting	15.2% 5/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Investigations Alanine aminotransferase increased	15.2% 5/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Investigations Alkaline phosphatase increased	18.2% 6/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Investigations Aspartate aminotransferase increased	18.2% 6/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Investigations Lymphocyte count decreased	18.2% 6/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Investigations Platelet count decreased	9.1% 3/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Investigations Weight loss	9.1% 3/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Investigations White blood cell decreased	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Investigations Investigations - Other, specify	30.3% 10/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Metabolism and nutrition disorders Anorexia	21.2% 7/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Metabolism and nutrition disorders Dehydration	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Metabolism and nutrition disorders Hypocalcemia	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Metabolism and nutrition disorders Hypomagnesemia	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	12.1% 4/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Nervous system disorders Dizziness	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Nervous system disorders Dysgeusia	18.2% 6/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Eye disorders Blurred vision	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Eye disorders Dry eye	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Eye disorders Eye disorders - Other, specify	12.1% 4/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Respiratory, thoracic and mediastinal disorders Cough	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Respiratory, thoracic and mediastinal disorders Epistaxis	6.1% 2/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	9.1% 3/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).
Vascular disorders Hypertension	9.1% 3/33 • Assessed every 28 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. Thirty-three patients were included in the toxicity analysis (excluding one never treated and one without toxicity data collected).

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