Trial Outcomes & Findings for Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery (NCT NCT01164228)

Last Updated: 2023-06-15

Results Overview

Response is defined as either complete response (CR, disappearance of all lesions) or partial response (PR, at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

87 participants

Primary outcome timeframe

Assessed every 3 months for 2 years and every 6 months for year 3.

Results posted on

2023-06-15

Participant Flow

A total of 87 patients were enrolled between June 17, 2010 and November 12, 2015. The first patient was accrued on September 17, 2010.

Participant milestones

Participant milestones
Measure	Arm A (Sunitinib + Gemcitabine) Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.	Arm B (Sunitinib) Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Overall Study STARTED	47	40
Overall Study Receipt of Protocol Therapy	46	37
Overall Study Treated and Eligible Patients	45	37
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	44	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (Sunitinib + Gemcitabine) Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.	Arm B (Sunitinib) Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Overall Study Progression	24	25
Overall Study Adverse Event	13	7
Overall Study Death	1	1
Overall Study Withdrawal by Subject	2	0
Overall Study Physician Decision	1	2
Overall Study Symptomatic deterioration	1	0
Overall Study Never started treatment	1	3
Overall Study Ineligible	1	0

Baseline Characteristics

Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Sunitinib + Gemcitabine) n=45 Participants Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.	Arm B (Sunitinib) n=37 Participants Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.	Total n=82 Participants Total of all reporting groups
Age, Continuous	59 years n=5 Participants	61 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	24 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	36 Participants n=7 Participants	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	32 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed every 3 months for 2 years and every 6 months for year 3.

Population: Eligible and treated patients

Outcome measures

Outcome measures
Measure	Arm A (Sunitinib + Gemcitabine) n=45 Participants Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.	Arm B (Sunitinib) n=37 Participants Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Proportion of Patients With Response	0.18 proportion of participants Interval 0.11 to 0.29	0.11 proportion of participants Interval 0.051 to 0.22

SECONDARY outcome

Timeframe: Assessed every 3 months for 2 years and every 6 months for year 3.

Population: Eligible and treated patients

Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is defined as follows: * At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. * Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Arm A (Sunitinib + Gemcitabine) n=45 Participants Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.	Arm B (Sunitinib) n=37 Participants Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Progression-free Survival	4.5 months Interval 3.0 to 5.8	3.6 months Interval 3.0 to 7.7

SECONDARY outcome

Timeframe: Assessed every 3 months for 2 years and every 6 months for year 3.

Population: Eligible and treated patients

Overall survival is defined as the time from randomization to death or date last known alive.

Outcome measures

Outcome measures
Measure	Arm A (Sunitinib + Gemcitabine) n=45 Participants Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.	Arm B (Sunitinib) n=37 Participants Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Overall Survival	9.4 months Interval 7.4 to 13.0	7.8 months Interval 7.0 to 13.7

Adverse Events

Arm A (Sunitinib + Gemcitabine)

Serious events: 36 serious events

Other events: 40 other events

Deaths: 41 deaths

Arm B (Sunitinib)

Serious events: 17 serious events

Other events: 27 other events

Deaths: 31 deaths

Serious adverse events

Other adverse events

Additional Information

Study Statistician

ECOG-ACRIN Biostatistics Center

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Arm A (Sunitinib + Gemcitabine) n=46 participants at risk Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.	Arm B (Sunitinib) n=37 participants at risk Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Blood and lymphatic system disorders Anemia	30.4% 14/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Cardiac disorders Chest pain - cardiac	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Cardiac disorders Heart failure	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Cardiac disorders Myocardial infarction	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Cardiac disorders Pericardial effusion	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
General disorders Fatigue	21.7% 10/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	10.8% 4/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
General disorders Fever	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
General disorders Malaise	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
General disorders Multi-organ failure	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
General disorders Pain	0.00% 0/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Diarrhea	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Nausea	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Stomach pain	0.00% 0/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Vomiting	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Infections and infestations Sepsis	0.00% 0/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Injury, poisoning and procedural complications Fall	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Alanine aminotransferase increased	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Aspartate aminotransferase increased	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Blood bilirubin increased	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Creatinine increased	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations GGT increased	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Hemoglobin increased	6.5% 3/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Lymphocyte count decreased	15.2% 7/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Neutrophil count decreased	41.3% 19/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Platelet count decreased	13.0% 6/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Weight gain	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations White blood cell decreased	15.2% 7/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Anorexia	8.7% 4/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Dehydration	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	8.1% 3/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hyperglycemia	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hyperkalemia	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hyperuricemia	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hypoalbuminemia	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hyponatremia	6.5% 3/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Back pain	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	8.7% 4/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Syncope	0.00% 0/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.

Other adverse events
Measure	Arm A (Sunitinib + Gemcitabine) n=46 participants at risk Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.	Arm B (Sunitinib) n=37 participants at risk Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Blood and lymphatic system disorders Anemia	41.3% 19/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	8.1% 3/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
General disorders Edema limbs	6.5% 3/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
General disorders Fatigue	50.0% 23/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	10.8% 4/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	13.5% 5/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue - Other	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Endocrine disorders Hypothyroidism	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Diarrhea	10.9% 5/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	16.2% 6/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Dyspepsia	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Mucositis oral	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	16.2% 6/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Nausea	39.1% 18/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	13.5% 5/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Stomach pain	6.5% 3/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Vomiting	10.9% 5/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Alanine aminotransferase increased	10.9% 5/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Alkaline phosphatase increased	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Aspartate aminotransferase increased	10.9% 5/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Creatinine increased	8.7% 4/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	8.1% 3/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Hemoglobin increased	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Lymphocyte count decreased	8.7% 4/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	10.8% 4/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Neutrophil count decreased	30.4% 14/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	8.1% 3/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Platelet count decreased	15.2% 7/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations White blood cell decreased	23.9% 11/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	13.5% 5/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Anorexia	15.2% 7/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Dehydration	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hyperglycemia	6.5% 3/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hypoalbuminemia	8.7% 4/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.2% 1/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	8.1% 3/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Dizziness	8.7% 4/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Dysgeusia	15.2% 7/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	13.5% 5/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Headache	4.3% 2/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.4% 2/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.2% 7/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.7% 1/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Vascular disorders Hypertension	30.4% 14/46 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	24.3% 9/37 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment up to 3 years Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.