Trial Outcomes & Findings for Ridaforolimus and Vorinostat in Treating Patients With Advanced Solid Tumors or Lymphoma (NCT NCT01169532)

Last Updated: 2021-02-21

Results Overview

MTD denoted as the highest dose at which no more than one of six patients experienced a dose limiting toxicity (DLT), and expanded to a total of 12 patients. Any drug-related grade 3 or 4 toxicity occurring during the first three weeks of treatment (except nausea, vomiting, diarrhea, serum lipid elevation, or transient electrolyte abnormality that resolved to a grade of 0-2 with medical management) was considered a dose limiting toxicity (DLT). Assessed by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 4.0.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

First 3 weeks of treatment

Results posted on

2021-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Ridaforolimus and Vorinostat) Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ridaforolimus: Given PO vorinostat: Given PO biopsy: Optional correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Ridaforolimus and Vorinostat) Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ridaforolimus: Given PO vorinostat: Given PO biopsy: Optional correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Ridaforolimus and Vorinostat in Treating Patients With Advanced Solid Tumors or Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Ridaforolimus and Vorinostat) n=15 Participants Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ridaforolimus: Given PO vorinostat: Given PO biopsy: Optional correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: First 3 weeks of treatment

Outcome measures

Outcome measures
Measure	Treatment (Ridaforolimus and Vorinostat) n=15 Participants Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ridaforolimus: Given PO vorinostat: Given PO biopsy: Optional correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Maximum Tolerated Dose (MTD) Ridaforolimus qd days 1-5 every week	20 milligrams
Maximum Tolerated Dose (MTD) Vorinostat bid days 1-3 every week	100 milligrams

SECONDARY outcome

Timeframe: 1 year

Kaplan Meier curves will be used. Proportions, 95% confidence intervals, and cumulative incidence curves will be used to characterize response rates.

Outcome measures

Outcome measures
Measure	Treatment (Ridaforolimus and Vorinostat) n=15 Participants Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ridaforolimus: Given PO vorinostat: Given PO biopsy: Optional correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Progression Free Survival	17.1 weeks Interval 6.6 to 21.4

SECONDARY outcome

Timeframe: 1 year

Population: Upper limit of confidence interval not reached because at least one patient was still alive at time of data cut-off. Upper limit given is amount of time (in weeks) of overall survival at data cut-off point.

Kaplan Meier curves will be used. Proportions, 95% confidence intervals, and cumulative incidence curves will be used to characterize response rates.

Outcome measures

Outcome measures
Measure	Treatment (Ridaforolimus and Vorinostat) n=15 Participants Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ridaforolimus: Given PO vorinostat: Given PO biopsy: Optional correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Survival	40.7 weeks Interval 28.3 to 162.0

Adverse Events

Treatment (Ridaforolimus and Vorinostat)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Ridaforolimus and Vorinostat) n=15 participants at risk Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ridaforolimus: Given PO vorinostat: Given PO biopsy: Optional correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Gastrointestinal disorders Oral Mucositis	80.0% 12/15 • 162 weeks
General disorders Fatigue	73.3% 11/15 • 162 weeks
Metabolism and nutrition disorders Anorexia	73.3% 11/15 • 162 weeks
Blood and lymphatic system disorders Thrombocytopenia	73.3% 11/15 • 162 weeks
Metabolism and nutrition disorders Hyperglycemia	60.0% 9/15 • 162 weeks
Blood and lymphatic system disorders Anemia	60.0% 9/15 • 162 weeks
Gastrointestinal disorders Diarrhea	46.7% 7/15 • 162 weeks
Gastrointestinal disorders Nausea	40.0% 6/15 • 162 weeks
Metabolism and nutrition disorders weight loss	40.0% 6/15 • 162 weeks
Investigations Elevated AST	40.0% 6/15 • 162 weeks
Metabolism and nutrition disorders hypertriglyceridemia	40.0% 6/15 • 162 weeks
Investigations Elevated ALT	33.3% 5/15 • 162 weeks
General disorders Dysguesia	33.3% 5/15 • 162 weeks
Skin and subcutaneous tissue disorders Rash, Maculo-Papular	33.3% 5/15 • 162 weeks
Blood and lymphatic system disorders Neutropenia	26.7% 4/15 • 162 weeks
Investigations Elevated Creatinine	26.7% 4/15 • 162 weeks
Gastrointestinal disorders Constipation	20.0% 3/15 • 162 weeks
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 3/15 • 162 weeks

Additional Information

Elizabeth Plimack

Fox Chase Cancer Center

Phone: 215-728-3889

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place