Trial Outcomes & Findings for Vorinostat Plus Radiation Therapy in Pancreatic Cancer (NCT NCT00831493)

Results Overview

MTD is maximum dose at which 6 patients are treated and there is at most 1 patient with dose limiting toxicities (DLT). Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Toxicity assessment at 6 weeks following chemoradiation (6 weeks)

Results posted on

2012-02-28

Participant Flow

The recruitment period is May 8, 2009 to October 5, 2010. All participants were recruited at UT MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Vorinostat + Radiation Therapy Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Vorinostat + Radiation Therapy Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
Overall Study Intractable nausea and vomiting	1

Baseline Characteristics

Vorinostat Plus Radiation Therapy in Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vorinostat + Radiation Therapy n=3 Participants Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
Age Continuous	55 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Toxicity assessment at 6 weeks following chemoradiation (6 weeks)

Population: Analysis per protocol; Of the three participants enrolled only two were eligible for MTD calculation.

MTD is maximum dose at which 6 patients are treated and there is at most 1 patient with dose limiting toxicities (DLT). Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE).

Outcome measures

Outcome measures
Measure	Vorinostat + Radiation Therapy n=2 Participants Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
Maximum Tolerated Dose (MTD) of Vorinostat + Chemoradiation	200 mg

Adverse Events

Vorinostat + Radiation Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vorinostat + Radiation Therapy n=3 participants at risk Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
Gastrointestinal disorders vomiting	33.3% 1/3 • 2.5 months

Additional Information

Sunil Krishnan, MD / Associate Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place