Trial Outcomes & Findings for Tandutinib in Treating Patients Who Have Undergone Surgery for Metastatic Kidney Cancer (NCT NCT00408902)

Last Updated: 2017-11-22

Results Overview

The number of patients that reach complete response (CR)defined as the disappearance of all target lesions or partial response (PR)defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Up to 4 weeks after completion of study treatment

Results posted on

2017-11-22

Participant Flow

Patients were recruited from Cleveland Clinic between November 2006 and August 2007.

Participant milestones

Participant milestones
Measure	TandutinibTreatment Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	10
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	TandutinibTreatment Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Lack of Efficacy	7
Overall Study Adverse Event	3

Baseline Characteristics

Tandutinib in Treating Patients Who Have Undergone Surgery for Metastatic Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TandutinibTreatment n=10 Participants Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	63.6 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks after completion of study treatment

Population: Intent to treat

Outcome measures

Outcome measures
Measure	TandutinibTreatment n=10 Participants Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Efficacy, Taking Into Account Both Objective Response and Meaningful Reductions in Tumor Burden That do Not Meet the RECIST Criteria for PR or CR (e.g., 5-30% Reduction in RECIST Defined Tumor Burden) Complete Response (CR)	0 participants
Overall Efficacy, Taking Into Account Both Objective Response and Meaningful Reductions in Tumor Burden That do Not Meet the RECIST Criteria for PR or CR (e.g., 5-30% Reduction in RECIST Defined Tumor Burden) Partial Response (PR)	0 participants

SECONDARY outcome

Timeframe: Followed until progression or death for approximately 3 years

Population: Data was not collected as study closed prior to time period for analysis.

Estimated using the method of Kaplan and Meier.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 weeks after completion of study treatment

Population: Intent to treat

Estimated time to progression using the method of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	TandutinibTreatment n=10 Participants Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	1.5 months Interval 0.9 to 2.1

Adverse Events

TandutinibTreatment

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TandutinibTreatment n=10 participants at risk Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. tandutinib: Given orally laboratory biomarker analysis: Correlative studies
General disorders Fatigue	30.0% 3/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Blood and lymphatic system disorders Hemolysis	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Metabolism and nutrition disorders Hypercalcemia	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.

Other adverse events

Other adverse events
Measure	TandutinibTreatment n=10 participants at risk Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. tandutinib: Given orally laboratory biomarker analysis: Correlative studies
Metabolism and nutrition disorders Anorexia	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Metabolism and nutrition disorders Blood Urea Nitrogen	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Musculoskeletal and connective tissue disorders Chest pain (non-cardiac and non-pleuritic)	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Gastrointestinal disorders Constipation	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 2/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Investigations Creatinine	30.0% 3/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Psychiatric disorders Depression	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Gastrointestinal disorders Diarrhea patients without colostomy	80.0% 8/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Nervous system disorders Dizziness/lightheadedness	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Skin and subcutaneous tissue disorders Dry skin	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	30.0% 3/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Vascular disorders Edema	50.0% 5/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
General disorders Fatigue (lethargy, malaise, asthenia)	40.0% 4/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Gastrointestinal disorders Gastrointestinal-distention/bloating	20.0% 2/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Ear and labyrinth disorders Hearing w/o monitoring	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Blood and lymphatic system disorders Hemoglobin	70.0% 7/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Metabolism and nutrition disorders Hyperkalemia	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Metabolism and nutrition disorders Hyperuricemia	20.0% 2/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Metabolism and nutrition disorders Hypoalbuminemia	20.0% 2/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Metabolism and nutrition disorders Hypocalcemia	20.0% 2/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Investigations Hypokalemia	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Endocrine disorders Hypothyroidism	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Renal and urinary disorders Hypouricemia	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Psychiatric disorders Insomnia	20.0% 2/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Blood and lymphatic system disorders Lymphopenia	20.0% 2/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Psychiatric disorders Mood alteration-anxiety, agitation	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Musculoskeletal and connective tissue disorders Muscle weakness (not due to neuropathy)	20.0% 2/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Gastrointestinal disorders Nausea	70.0% 7/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Musculoskeletal and connective tissue disorders Pain	30.0% 3/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Cardiac disorders Palpitations	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Investigations Prolonged QTc interval (QTc > 0.48 seconds)	20.0% 2/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Renal and urinary disorders Protein	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Gastrointestinal disorders Retroperitoneal hemorrhage	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
General disorders Rigors, chills	30.0% 3/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Eye disorders Tearing (watery eyes)	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Blood and lymphatic system disorders Thrombocytopenia	20.0% 2/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Eye disorders Vision-blurred vision	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Respiratory, thoracic and mediastinal disorders Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Gastrointestinal disorders Vomiting	70.0% 7/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Metabolism and nutrition disorders Weight gain	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Metabolism and nutrition disorders Weight loss	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.
Respiratory, thoracic and mediastinal disorders Wheezing	10.0% 1/10 • Adverse events were collected while patients were on treatment and 4 weeks after treatment, up to 12 weeks.

Additional Information

Jorge Garcia MD

Case Comprehensive Cancer Center

Phone: 216-444-7774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60