Trial Outcomes & Findings for Bevacizumab With or Without MEDI-522 in Treating Patients With Unresectable or Metastatic Kidney Cancer (NCT NCT00684996)

NCT ID: NCT00684996

Last Updated: 2014-05-15

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: Up to 8 weeks
• Results posted on: 2014-05-15

Participant Flow

Participant milestones

Measure	Phase I Bevacizumab (10 mg/kg) + MEDI-522 Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
Overall Study STARTED	5
Overall Study Eligible	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Phase I Bevacizumab (10 mg/kg) + MEDI-522 Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
Overall Study Adverse Event	1
Overall Study Refusal unrelated to adverse event	1
Overall Study Progression/relapse	2
Overall Study Other reasons not protocol specified	1

Baseline Characteristics

Bevacizumab With or Without MEDI-522 in Treating Patients With Unresectable or Metastatic Kidney Cancer

Baseline characteristics by cohort

Measure	Phase I Bevacizumab (10 mg/kg) + MEDI-522 n=5 Participants Patients receive bevacizumab (10 mg/kg or 5mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
Age, Continuous	61.5 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Population: The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From date of registration to date of first observation of progressive disease, systemic deterioration, or death due to any cause, assessed up to 3 years

Population: The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.

Measured from date of registration to date of first observation of progressive disease, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 3 years

Population: The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.

Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From date of registration to date of death due to any cause, assessed up to 3 years

Population: The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.

Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 3 years

Population: The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.

Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of nonmeasurable disease. No new lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years

Population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.

Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Outcome measures

Measure	Phase I Bevacizumab (10 mg/kg) + MEDI-522 n=3 Participants Patients receive bevacizumab (10 mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.	Phase II Arm II Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Allergic reaction/hypersensitivity	1 Participants	—
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dyspnea (shortness of breath)	1 Participants	—

Adverse Events

Phase I Bevacizumab (10 mg/kg) + MEDI-522

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phase I Bevacizumab (10 mg/kg) + MEDI-522 n=3 participants at risk Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
General disorders Rigors/chills	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Immune system disorders Allergic reaction/hypersensitivity	66.7% 2/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years

Other adverse events

Measure	Phase I Bevacizumab (10 mg/kg) + MEDI-522 n=3 participants at risk Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
Blood and lymphatic system disorders Hemoglobin	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Gastrointestinal disorders Nausea	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Gastrointestinal disorders Pain - Esophagus	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
General disorders Fatigue (asthenia, lethargy, malaise)	100.0% 3/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
General disorders Fever in absence of neutropenia, ANC lt1.0x10e9/L	66.7% 2/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
General disorders Flu-like syndrome	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
General disorders Rigors/chills	66.7% 2/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Infections and infestations Infection with unknown ANC - Upper airway NOS	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Investigations AST, SGOT	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Investigations Alkaline phosphatase	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Investigations Creatinine	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	66.7% 2/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Musculoskeletal and connective tissue disorders Pain - Joint	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Renal and urinary disorders Glomerular filtration rate	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Vascular disorders Hypertension	66.7% 2/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Vascular disorders Hypotension	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years
Vascular disorders Thrombosis/thrombus/embolism	33.3% 1/3 • Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years

Additional Information

Study Statistician

SWOG Statistical Center

Phone: 206-667-4623

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60