Trial Outcomes & Findings for Sunitinib Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With ES-SCLC (NCT NCT00616109)
NCT ID: NCT00616109
Last Updated: 2014-04-21
Results Overview
The proportion of patients who are progression-free at 4 months after starting sunitinib.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
4 Months Post Treatment
Results posted on
2014-04-21
Participant Flow
16 subjects recruited from 7/19/2007 to 2/1/2010 at University of Michigan, Ann Arbor(lead site), and sub-sites: The University of Detroit's Karmanos Cancer Institute, WSU, Detroit; Weill Cornell Medical College, NY; and Roswell Park Cancer Institute, NJ
Patients with histologically or cytologically documented Extensive-Stage Small Cell Lung Cancer (ES-SCLC) who had received no more than 4 cycles of frontline platinum plus etoposide chemotherapy and who demonstrated a response or stable disease were eligible. ES-SCLC was defined as disease extending beyond 1 hemothorax and regional lymph nodes.
Participant milestones
| Measure |
Sunitinib Maintenance Therapy
Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sunitinib Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With ES-SCLC
Baseline characteristics by cohort
| Measure |
Sunitinib Maintenance Therapy
n=16 Participants
Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
|
|---|---|
|
Age, Customized
|
66 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
|
Response to induction chemotherapy
CR (complete response)
|
3 participants
n=93 Participants
|
|
Response to induction chemotherapy
PR (partial response)
|
11 participants
n=93 Participants
|
|
Response to induction chemotherapy
SD (stable disease)
|
2 participants
n=93 Participants
|
|
Performance status
0
|
5 participants
n=93 Participants
|
|
Performance status
1
|
10 participants
n=93 Participants
|
|
Performance status
2
|
1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 4 Months Post TreatmentPopulation: All 16 patients enrolled received a median of 4 weeks sunitinib maintenance therapy. 1 patient who discontinued requested no follow up and was censored from survival analysis. All survival endpoints were analyzed using the Kaplan-Meier method (Kaplan El, Meier P, Non-parametric Estimation from Incomplete Observations, J Am Stat Association, 1958)
The proportion of patients who are progression-free at 4 months after starting sunitinib.
Outcome measures
| Measure |
Sunitinib Maintenance Therapy
n=16 Participants
Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy. All patients who have received at least one cycle of sunitinib will be considered evaluable for response.
|
|---|---|
|
Progression Free Survival Rate
|
13 percentage of patients with PFS
Interval 2.0 to 33.0
|
SECONDARY outcome
Timeframe: up to 4 months post treatmentPopulation: 15 participants in Sunitinib maintenance therapy (main study) were enrolled and were evaluable for this outcome measure. Although 16 patients were enrolled, one patient opted to discontinue therapy, refused further follow-up, and was therefore censored from survival analysis.
Survival will be defined as the time from the first day of therapy to the date of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. Survival for induction therapy will be calculated from day 1 of first cycle of chemotherapy. Survival for post-induction therapy will be calculated from the date the patient starts sunitinib.
Outcome measures
| Measure |
Sunitinib Maintenance Therapy
n=15 Participants
Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy. All patients who have received at least one cycle of sunitinib will be considered evaluable for response.
|
|---|---|
|
Median Overall Survival
|
8.2 months
Interval 6.2 to 14.7
|
SECONDARY outcome
Timeframe: 12 weeks (2 cycles)Population: Patients who received at least 2 cycles of study therapy (maintenance sunitinib)
Scans were performed every 2 cycles to evaluate for response/progression. Response was assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Patients would be considered to have an objective response if they experience CR (Complete Response - Disappearance of all clinical and radiological evidence of target lesions and/or non-target lesions) or PR (Partial Response - A 30% or greater decrease in the sum of LD of all lesions in reference to the baseline sum LD).
Outcome measures
| Measure |
Sunitinib Maintenance Therapy
n=15 Participants
Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy. All patients who have received at least one cycle of sunitinib will be considered evaluable for response.
|
|---|---|
|
Percent of Patients With an Objective Response
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: All patients who received sunitinib maintenance therapy were evaluable for toxicity and tolerability analysis.
Tolerability of Sunitinib will be evaluated by looking at the number of participants who discontinue drug due to toxicity. Toxicity was graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v.3.0. In the event of any CTC, version 3.0 drug-related grade 3 or 4 non-hematologic or grade 4 hematologic adverse event(s), drug should be held until the toxicity resolves to \< grade 1 and then the drug should be restarted at a one dose-level reduction. Recovery to acceptable levels of toxicity must occur within 4 weeks to allow continuation in the study. No more than 2 dose reductions are permitted for any patient. If further dose reduction is required, the patient must be removed from the study.
Outcome measures
| Measure |
Sunitinib Maintenance Therapy
n=16 Participants
Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy. All patients who have received at least one cycle of sunitinib will be considered evaluable for response.
|
|---|---|
|
Number of Patients That Discontinue Drug Due to Toxicity
|
5 participants
|
Adverse Events
Sunitinib Maintenance Therapy
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sunitinib Maintenance Therapy
n=16 participants at risk
Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Cardiac disorders
Cardiopulmonary arrest
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Cardiac disorders
Chest pain
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
General disorders
Death
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Infection, Lung (pneumonia)
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
General disorders
Pain in extremity
|
6.2%
1/16 • Number of events 1 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
Other adverse events
| Measure |
Sunitinib Maintenance Therapy
n=16 participants at risk
Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.2%
5/16 • Number of events 5 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Nervous system disorders
Ataxia
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
31.2%
5/16 • Number of events 5 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Gastrointestinal disorders
Constipation
|
31.2%
5/16 • Number of events 6 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.2%
5/16 • Number of events 5 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Gastrointestinal disorders
Diarrhea
|
31.2%
5/16 • Number of events 7 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.8%
3/16 • Number of events 9 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
General disorders
Edema limbs
|
12.5%
2/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
General disorders
Fatigue
|
62.5%
10/16 • Number of events 15 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Nervous system disorders
Headache
|
37.5%
6/16 • Number of events 6 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
18.8%
3/16 • Number of events 4 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Vascular disorders
Hypertension
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.8%
3/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Psychiatric disorders
Insomnia
|
18.8%
3/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Blood and lymphatic system disorders
Leukocytes
|
31.2%
5/16 • Number of events 6 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Gastrointestinal disorders
Mucositis oral
|
18.8%
3/16 • Number of events 6 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
18.8%
3/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.8%
3/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Gastrointestinal disorders
Nausea
|
62.5%
10/16 • Number of events 12 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Blood and lymphatic system disorders
Neutrophils
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.8%
3/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
12.5%
2/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Blood and lymphatic system disorders
Platelets
|
43.8%
7/16 • Number of events 11 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
18.8%
3/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Nervous system disorders
Speech disorder
|
12.5%
2/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
12.5%
2/16 • Number of events 2 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Gastrointestinal disorders
Taste alteration
|
18.8%
3/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Renal and urinary disorders
Urine discoloration
|
18.8%
3/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
18.8%
3/16 • Number of events 3 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Gastrointestinal disorders
Vomiting
|
43.8%
7/16 • Number of events 7 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
|
Investigations
Weight loss
|
25.0%
4/16 • Number of events 6 • Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.
Treatment was held for Participants with grade 4 hematologic or grade 3-4 non-hematologic toxicities until resolution to grade 2 or less. Treatment was then restarted at a dose of 3.75 mg. A second dose reduction to 25 mg was permitted. Treatment discontinued for a third dose reduction or life-threatening, irreversible or unacceptable toxicity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place