Trial Outcomes & Findings for Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial (NCT NCT04284774)

NCT ID: NCT04284774

Last Updated: 2025-12-04

Results Overview

A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Up to 2 years from study entry

Results posted on

2025-12-04

Participant Flow

Between 10Oct2020 and 31Mar2024, 7 subjects matched and 5 were included and treated with study drug. Subjects received a median of 2 cycles of study drug (range 1-4 cycles).

Participant milestones

Participant milestones
Measure
Treatment (Tipifarnib)
Patients receive tipifarnib tablets 350 mg/m\^2/dose PO or via nasogastric or gastric tube BID (maximum 600 mg/dose BID) with food on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Overall Study
STARTED
5
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Treatment (Tipifarnib)
Patients receive tipifarnib tablets 350 mg/m\^2/dose PO or via nasogastric or gastric tube BID (maximum 600 mg/dose BID) with food on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Overall Study
Progressive disease
5

Baseline Characteristics

Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment (Tipifarnib)
n=5 Participants
Patients receive tipifarnib tablets 350 mg/m\^2/dose PO or via nasogastric or gastric tube BID (maximum 600 mg/dose BID) with food on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Age, Categorical
<=18 years
5 Participants
n=3 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=3 Participants
Age, Categorical
>=65 years
0 Participants
n=3 Participants
Age, Continuous
8.2 years
STANDARD_DEVIATION 5.7 • n=3 Participants
Sex: Female, Male
Female
1 Participants
n=3 Participants
Sex: Female, Male
Male
4 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=3 Participants
Race (NIH/OMB)
Asian
0 Participants
n=3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=3 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=3 Participants
Race (NIH/OMB)
White
2 Participants
n=3 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=3 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=3 Participants
Region of Enrollment
United States
5 participants
n=3 Participants

PRIMARY outcome

Timeframe: Up to 2 years from study entry

A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors.

Outcome measures

Outcome measures
Measure
Treatment (Tipifarnib)
n=5 Participants
Patients receive tipifarnib tablets 350 mg/m\^2/dose PO or via nasogastric or gastric tube BID (maximum 600 mg/dose BID) with food on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Tipifarnib
0 percentage of patients
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 6 months from study entry

The Kaplan-Meier method will be used to estimate the 6-month PFS. PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years from study entry

Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 7 years

Will evaluate other biomarkers as predictors of response to tipifarnib and whether tumors that harbor different missense mutations or fusions will demonstrate differential response to treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, prior to cycle 5, end of treatment, assessed up to 7 years

Will explore approaches to the profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Tipifarnib)

Serious events: 2 serious events
Other events: 3 other events
Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure
Treatment (Tipifarnib)
n=5 participants at risk
Patients receive tipifarnib tablets 350 mg/m\^2/dose PO or via nasogastric or gastric tube BID (maximum 600 mg/dose BID) with food on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
General disorders
Disease progression
40.0%
2/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders
Dyspnea
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.

Other adverse events

Other adverse events
Measure
Treatment (Tipifarnib)
n=5 participants at risk
Patients receive tipifarnib tablets 350 mg/m\^2/dose PO or via nasogastric or gastric tube BID (maximum 600 mg/dose BID) with food on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
General disorders
Edema limbs
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders
Diarrhea
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders
Nausea
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders
Vomiting
40.0%
2/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
General disorders
Disease progression
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Blood and lymphatic system disorders
Anemia
60.0%
3/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders
Abdominal distension
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders
Abdominal pain
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders
Constipation
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
General disorders
Fatigue
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations
Upper respiratory infection
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations
Alkaline phosphatase increased
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations
Blood bicarbonate decreased
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations
Lymphocyte count decreased
40.0%
2/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations
Platelet count decreased
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations
Weight loss
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Metabolism and nutrition disorders
Anorexia
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Metabolism and nutrition disorders
Hypercalcemia
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Metabolism and nutrition disorders
Hyperglycemia
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Metabolism and nutrition disorders
Hypokalemia
60.0%
3/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Metabolism and nutrition disorders
Hyponatremia
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Metabolism and nutrition disorders
Hypophosphatemia
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Musculoskeletal and connective tissue disorders
Bone pain
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Musculoskeletal and connective tissue disorders
Chest wall pain
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Musculoskeletal and connective tissue disorders
Pain in extremity
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Nervous system disorders
Dizziness
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Nervous system disorders
Somnolence
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Psychiatric disorders
Insomnia
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders
Dyspnea
20.0%
1/5 • Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years.
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 6264470064

Results disclosure agreements

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

Restriction type: LTE60