Trial Outcomes & Findings for Testing AZD4547 as a Potential Targeted Treatment in Cancers With FGFR Genetic Changes (MATCH-Subprotocol W) (NCT NCT04439240)

Last Updated: 2021-06-29

Results Overview

Overall response rate was defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients. Best overall response 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. The 90% two-sided binomial exact confidence interval was calculated for ORR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary 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

Results posted on

2021-06-29

Participant Flow

Subprotocol W was activated on May 31, 2016. 70 patients were assigned to Subprotocol W after screening, all from screening cohort. Of the 70 patients, 52 patients from 47 different sites enrolled in the study between July 2016 and June 2017.

To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For subprotocol W, patients had to have tumors harboring aberrations in FGFR 1-3.

Participant milestones

Participant milestones
Measure	Treatment (AZD4547) Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO
Overall Study STARTED	52
Overall Study Started Protocol Therapy	50
Overall Study Eligible	49
Overall Study Eligible and Started Protocol Therapy	48
Overall Study Reported Adverse Events Data	49
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (AZD4547) Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO
Overall Study Ineligible	2
Overall Study Never started treatment	2
Overall Study Adverse Event	12
Overall Study Death	2
Overall Study Disease progression	25
Overall Study Other diseases	2
Overall Study Withdrawal by Subject	3
Overall Study Clinical concerns for progression and increasing tumor marker	1
Overall Study Symptomatic decline	1
Overall Study Pogression of the lymphadenopathy	1
Overall Study Clinical progression	1

Baseline Characteristics

Testing AZD4547 as a Potential Targeted Treatment in Cancers With FGFR Genetic Changes (MATCH-Subprotocol W)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (AZD4547) n=48 Participants Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO
Age, Continuous	61 years n=99 Participants
Sex: Female, Male Female	39 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	43 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants

PRIMARY 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 and treated patients

Outcome measures

Outcome measures
Measure	Treatment (AZD4547) n=48 Participants Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO
Overall Response Rate (ORR)	8 percentage of participants Interval 3.0 to 18.0

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 is determined

Population: Eligible and treated patients

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. The 6-month PFS rate was estimated using the Kaplan-Meier method which can provide a point estimate for any specific time point. 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.

Outcome measures

Outcome measures
Measure	Treatment (AZD4547) n=48 Participants Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO
6-month Progression-free Survival (PFS) Rate	15 percentage of participants Interval 8.0 to 31.0

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 and treated 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.

Outcome measures

Outcome measures
Measure	Treatment (AZD4547) n=48 Participants Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO
Progression Free Survival (PFS)	3.4 months Interval 1.8 to 4.7

Adverse Events

Treatment (AZD4547)

Serious events: 19 serious events

Other events: 41 other events

Deaths: 44 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (AZD4547) n=49 participants at risk Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO
Blood and lymphatic system disorders Anemia	4.1% 2/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Blood and lymphatic system disorders Febrile neutropenia	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	6.1% 3/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Abdominal pain	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Constipation	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Esophageal pain	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Mucositis oral	14.3% 7/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Small intestinal obstruction	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Infections and infestations Sepsis	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations Alanine aminotransferase increased	6.1% 3/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations Aspartate aminotransferase increased	8.2% 4/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations GGT increased	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations Neutrophil count decreased	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Metabolism and nutrition disorders Hypoalbuminemia	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Metabolism and nutrition disorders Hyponatremia	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Metabolism and nutrition disorders Hypophosphatemia	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Nervous system disorders Dizziness	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Nervous system disorders Peripheral sensory neuropathy	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Nervous system disorders Syncope	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Eye disorders Dry eye	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	2.0% 1/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)

Other adverse events

Other adverse events
Measure	Treatment (AZD4547) n=49 participants at risk Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO
Blood and lymphatic system disorders Anemia	18.4% 9/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
General disorders Fatigue	38.8% 19/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Skin and subcutaneous tissue disorders Alopecia	28.6% 14/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Skin and subcutaneous tissue disorders Dry skin	18.4% 9/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Skin and subcutaneous tissue disorders Nail discoloration	14.3% 7/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Skin and subcutaneous tissue disorders Nail loss	12.2% 6/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	14.3% 7/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Skin and subcutaneous tissue disorders Pruritus	6.1% 3/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	8.2% 4/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Constipation	24.5% 12/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Diarrhea	20.4% 10/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Dry mouth	42.9% 21/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Dyspepsia	6.1% 3/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Gastroesophageal reflux disease	8.2% 4/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Mucositis oral	34.7% 17/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Nausea	24.5% 12/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Gastrointestinal disorders Vomiting	22.4% 11/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations Alanine aminotransferase increased	12.2% 6/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations Alkaline phosphatase increased	20.4% 10/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations Aspartate aminotransferase increased	10.2% 5/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations Blood bilirubin increased	6.1% 3/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations Creatinine increased	12.2% 6/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations Lymphocyte count decreased	10.2% 5/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations Neutrophil count decreased	6.1% 3/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations Weight loss	14.3% 7/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Investigations White blood cell decreased	12.2% 6/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Metabolism and nutrition disorders Anorexia	26.5% 13/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Metabolism and nutrition disorders Hypercalcemia	12.2% 6/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Metabolism and nutrition disorders Hypomagnesemia	6.1% 3/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Metabolism and nutrition disorders Hyponatremia	10.2% 5/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Metabolism and nutrition disorders Hypophosphatemia	6.1% 3/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Nervous system disorders Dysgeusia	20.4% 10/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Nervous system disorders Peripheral sensory neuropathy	6.1% 3/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Eye disorders Blurred vision	12.2% 6/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Eye disorders Dry eye	24.5% 12/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Eye disorders Eye disorders - Other, specify	20.4% 10/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Respiratory, thoracic and mediastinal disorders Dyspnea	10.2% 5/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.1% 3/49 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 52 patients enrolled to the trial were monitored for mortality. Of the 50 patients who received protocol therapy, 49 were evaluable for AEs (1 patient had no toxicity data)

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