Trial Outcomes & Findings for Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy (NCT NCT00095836)

Last Updated: 2017-05-31

Results Overview

Response rate as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Tumor assessment is performed within 4 weeks of initiation of treatment and then every 8 weeks. If a patient has stable disease for four tumor assessments (6 months), then tumor assessment may occur every 4 months. If the patient continues to experience stable disease after 2 years, tumor assessments may occur every 6 months. If the patient continues to experience stable disease after 5 years, tumor assessments may occur once a year. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

3 Months, 6 Months, 1 Year

Results posted on

2017-05-31

Participant Flow

Patients were enrolled from Massachusetts General Hospital and the Dana-Farber Cancer Institute

Participant milestones

Participant milestones
Measure	Gefitinib 250mg gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Overall Study STARTED	27
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Gefitinib 250mg gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Overall Study Lost to Follow-up	1
Overall Study Adverse Event	1
Overall Study Death	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefitinib 250mg n=27 Participants Gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=27 Participants
Age, Categorical >=65 years	13 Participants n=27 Participants
Age, Continuous	64.5 years STANDARD_DEVIATION 9.5 • n=27 Participants
Sex: Female, Male Female	11 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=27 Participants
Region of Enrollment United States	27 participants n=27 Participants
ECOG Performance Status 0-1	25 Participants n=27 Participants
ECOG Performance Status 2	2 Participants n=27 Participants
Stage Locally Advanced	2 Participants n=27 Participants
Stage Metastatic	25 Participants n=27 Participants
Metastatic sites Lung-only	10 Participants n=25 Participants • Participants with metastatic cancer
Metastatic sites Lung + extra-pulmonary metastases	15 Participants n=25 Participants • Participants with metastatic cancer
Prior therapy Radioactive iodine	17 participants n=27 Participants
Prior therapy Chemotherapy	6 participants n=27 Participants
Prior therapy External beam radiotherapy	23 participants n=27 Participants
Histology Papillary	11 Participants n=27 Participants
Histology Follicular	6 Participants n=27 Participants
Histology Anaplastic	5 Participants n=27 Participants
Histology Medullary	4 Participants n=27 Participants
Histology Hürthle cell	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: 3 Months, 6 Months, 1 Year

Population: Two patients lost to follow-up prior to assessment of tumor response

Outcome measures

Outcome measures
Measure	Gefitinib 250mg n=25 Participants gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Objective Tumor Response Rate at 3, 6, and 12 Months Complete Response : 3 Months	0 participants
Objective Tumor Response Rate at 3, 6, and 12 Months Partial Response : 3 Months	0 participants
Objective Tumor Response Rate at 3, 6, and 12 Months Stable Disease : 3 Months	12 participants
Objective Tumor Response Rate at 3, 6, and 12 Months Progressive Disease : 3 Months	13 participants
Objective Tumor Response Rate at 3, 6, and 12 Months Complete Response : 6 Months	0 participants
Objective Tumor Response Rate at 3, 6, and 12 Months Partial Response : 6 Months	0 participants
Objective Tumor Response Rate at 3, 6, and 12 Months Stable Disease : 6 Months	6 participants
Objective Tumor Response Rate at 3, 6, and 12 Months Progressive Disease : 6 Months	19 participants
Objective Tumor Response Rate at 3, 6, and 12 Months Complete Response : 12 Months	0 participants
Objective Tumor Response Rate at 3, 6, and 12 Months Partial Response : 12 Months	0 participants
Objective Tumor Response Rate at 3, 6, and 12 Months Stable Disease : 12 Months	3 participants
Objective Tumor Response Rate at 3, 6, and 12 Months Progressive Disease : 12 Months	22 participants

SECONDARY outcome

Timeframe: Through study completion, on average 12 months

Drug related toxicity as assessed by NCI CTCAE that occurred in more than 10% of patients

Outcome measures

Outcome measures
Measure	Gefitinib 250mg n=27 Participants gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Toxicity Rash: Grade 0	13 participants
Toxicity Rash: Grade 1	9 participants
Toxicity Rash: Grade 2	3 participants
Toxicity Rash: Grade 3	2 participants
Toxicity Diarrhea: Grade 0	16 participants
Toxicity Diarrhea: Grade 1	8 participants
Toxicity Diarrhea: Grade 2	2 participants
Toxicity Diarrhea: Grade 3	1 participants
Toxicity Nausea: Grade 0	22 participants
Toxicity Nausea: Grade 1	5 participants
Toxicity Anorexia: Grade 0	24 participants
Toxicity Anorexia: Grade 1	3 participants

SECONDARY outcome

Timeframe: From the time of enrollment until disease progression or death, whichever came first

The median progression-free survival as assessed by RECIST criteria (Response Evaluation Criteria In Solid Tumors) measured from the time of enrollment until disease progression or death. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Gefitinib 250mg n=27 Participants gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Median Progression-free Survival	3.7 Months Interval 1.8 to 5.7

SECONDARY outcome

Timeframe: 5 years

The median overall survival time, measured from the time of enrollment until death.

Outcome measures

Outcome measures
Measure	Gefitinib 250mg n=27 Participants gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Overall Survival	17.5 Months Interval 9.2 to Participant was still alive at time of assessment

Adverse Events

Gefitinib 250mg

Serious events: 6 serious events

Other events: 27 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Gefitinib 250mg n=27 participants at risk gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Renal and urinary disorders Hematuria	3.7% 1/27 • Number of events 1 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Respiratory, thoracic and mediastinal disorders Airway obstruction (mucous)	3.7% 1/27 • Number of events 1 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.7% 1/27 • Number of events 1 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Gastrointestinal disorders Abdomen- pain	3.7% 1/27 • Number of events 1 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Nervous system disorders Stroke	3.7% 1/27 • Number of events 1 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Cardiac disorders Acute myocardial infarction	3.7% 1/27 • Number of events 1 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Nervous system disorders Transient ischemic attack	3.7% 1/27 • Number of events 1 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.

Other adverse events

Other adverse events
Measure	Gefitinib 250mg n=27 participants at risk gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin	14.8% 4/27 • Number of events 27 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Vascular disorders Hypotension	14.8% 4/27 • Number of events 66 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
General disorders Fatigue	40.7% 11/27 • Number of events 49 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
General disorders Fever w/o neutropenia	7.4% 2/27 • Number of events 5 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
General disorders Insomnia	7.4% 2/27 • Number of events 8 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
General disorders Odor (patient odor)	14.8% 4/27 • Number of events 22 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
General disorders Constitutional, other	7.4% 2/27 • Number of events 6 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Skin and subcutaneous tissue disorders Bruising	22.2% 6/27 • Number of events 57 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Skin and subcutaneous tissue disorders Induration/fibrosis	7.4% 2/27 • Number of events 4 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Skin and subcutaneous tissue disorders Photosensitivity	55.6% 15/27 • Number of events 110 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Skin and subcutaneous tissue disorders Skin-other	14.8% 4/27 • Number of events 8 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Gastrointestinal disorders Anorexia	22.2% 6/27 • Number of events 27 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Gastrointestinal disorders Constipation	11.1% 3/27 • Number of events 39 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Gastrointestinal disorders Teeth development	11.1% 3/27 • Number of events 40 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Gastrointestinal disorders Fistula, Duodenum	14.8% 4/27 • Number of events 26 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Gastrointestinal disorders Fistula, Gallbladder	22.2% 6/27 • Number of events 45 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Gastrointestinal disorders Fistula, Pharynx	7.4% 2/27 • Number of events 2 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Gastrointestinal disorders Fistula, Stomach	40.7% 11/27 • Number of events 66 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Gastrointestinal disorders Colon, hemorrhage	7.4% 2/27 • Number of events 28 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Infections and infestations Infection w/ gr3-4 neut, appendix	7.4% 2/27 • Number of events 2 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Nervous system disorders Confusion	7.4% 2/27 • Number of events 14 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Nervous system disorders Extrapyramidal movement	7.4% 2/27 • Number of events 3 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Nervous system disorders Laryngeal nerve dysfunction	7.4% 2/27 • Number of events 21 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Nervous system disorders Leak, CSF	7.4% 2/27 • Number of events 7 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Nervous system disorders Leukoencephalopathy	7.4% 2/27 • Number of events 7 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Nervous system disorders Mental status	7.4% 2/27 • Number of events 30 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Nervous system disorders Anxiety	14.8% 4/27 • Number of events 34 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Eye disorders Ocular-other	7.4% 2/27 • Number of events 2 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Musculoskeletal and connective tissue disorders Back, pain	22.2% 6/27 • Number of events 39 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Renal and urinary disorders Bladder, pain	7.4% 2/27 • Number of events 3 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
General disorders Pain-other	29.6% 8/27 • Number of events 28 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	33.3% 9/27 • Number of events 99 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Respiratory, thoracic and mediastinal disorders (DLCO)	22.2% 6/27 • Number of events 37 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Respiratory, thoracic and mediastinal disorders Fistula lung	7.4% 2/27 • Number of events 38 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-other	7.4% 2/27 • Number of events 2 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.
Renal and urinary disorders Renal/GU-other	7.4% 2/27 • Number of events 2 • Through study completion, an average of 1.5 years During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.

Additional Information

John Clark, MD

Massachusetts General Hospital

Phone: 617-724-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place