Trial Outcomes & Findings for Vorinostat and Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer (NCT NCT00324870)

Results Overview

Estimated by Kaplan-Meier method

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

37 participants

Primary outcome timeframe

At 6 months

Results posted on

2016-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD. Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I. vorinostat: Given orally bevacizumab: Given IV
Overall Study STARTED	37
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vorinostat and Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=37 Participants Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD. Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I. vorinostat: Given orally bevacizumab: Given IV
Age, Continuous	64 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants

PRIMARY outcome

Timeframe: At 6 months

Population: Progression free survival was summarized for the entire sample (n=37). The median survival times and 6-month survival rates are estim. based on the KP curve,w/ corresp. 95% confidence intervals using the log-log method. Conducted in SAS v9.3(Cary, NC). Progr.free survival time is calc. from date of first tx until date of progres./death or last fu.

Estimated by Kaplan-Meier method

Outcome measures

Outcome measures
Measure	Arm I n=37 Participants Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD. Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I. vorinostat: Given orally bevacizumab: Given IV
Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) (Phase II)	48.6 percent Interval 32.0 to 63.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months from first patient dosing

Determine the maximum tolerated dose of SAHA

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 years

To determine the clinical response rate of SAHA and Bevacizumab in patients with metastatic renal cell carcinoma.

Outcome measures

Outcome data not reported

Adverse Events

Arm I

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I n=37 participants at risk Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD. Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I. vorinostat: Given orally bevacizumab: Given IV
Blood and lymphatic system disorders thrombocytopenia	2.7% 1/37 • Number of events 1 • 7 years Adverse events were assessed through a regular investigator assessment
Respiratory, thoracic and mediastinal disorders pulmonary embolism	2.7% 1/37 • Number of events 1 • 7 years Adverse events were assessed through a regular investigator assessment
Nervous system disorders dizziness	2.7% 1/37 • Number of events 1 • 7 years Adverse events were assessed through a regular investigator assessment

Other adverse events

Other adverse events
Measure	Arm I n=37 participants at risk Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD. Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I. vorinostat: Given orally bevacizumab: Given IV
Nervous system disorders fatigue	59.5% 22/37 • Number of events 22 • 7 years Adverse events were assessed through a regular investigator assessment
Gastrointestinal disorders nausea	45.9% 17/37 • Number of events 17 • 7 years Adverse events were assessed through a regular investigator assessment
Gastrointestinal disorders anorexia	43.2% 16/37 • Number of events 16 • 7 years Adverse events were assessed through a regular investigator assessment
Gastrointestinal disorders diarrhea	35.1% 13/37 • Number of events 13 • 7 years Adverse events were assessed through a regular investigator assessment
Hepatobiliary disorders elevated creatinine	35.1% 13/37 • Number of events 13 • 7 years Adverse events were assessed through a regular investigator assessment

Additional Information

Michael Carducci, MD

Johns Hopkins University

Phone: 410-614-6337

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60