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Trial Outcomes & Findings for VTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas (NCT NCT01289210)

NCT ID: NCT01289210

Last Updated: 2019-09-25

Results Overview

Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Tumor assessment conducted at 12 weeks and every 3-6 months thereafter

Results posted on

2019-09-25

Participant Flow

Participant milestones

Participant milestones
Measure
VTX-2337 Plus Radiation
Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then administered weekly for 3 weeks in a 4 week cycle over 3 cycles.
Overall Study
STARTED
2
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
VTX-2337 Plus Radiation
Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then administered weekly for 3 weeks in a 4 week cycle over 3 cycles.
Overall Study
Adverse Event
1

Baseline Characteristics

VTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
VTX-2337 Plus Radiation
n=2 Participants
VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Tumor assessment conducted at 12 weeks and every 3-6 months thereafter

Population: Subjects who completed the first 4 weeks of treatment (radiation + 3 VTX-2337 injections) were evaluable for tumor response and immune response. The study was closed due to slow accrual. 2 subjects were enrolled; 1 was evaluable for the primary endpoint, the other discontinued prematurely and was evaluated for safety only (a secondary endpoint).

Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response.

Outcome measures

Outcome measures
Measure
VTX-2337 Plus Radiation
n=1 Participants
Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then admnistered weekly for 3 weeks in a 4 week cycle over 3 cycles.
Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.
1 participants

SECONDARY outcome

Timeframe: Safety assessed throughout study period.

Outcome measures

Outcome data not reported

Adverse Events

VTX-2337 Plus Radiation

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
VTX-2337 Plus Radiation
n=2 participants at risk
VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
General disorders
injection site reaction
100.0%
2/2 • Number of events 5
Gastrointestinal disorders
nausea
50.0%
1/2 • Number of events 6
Gastrointestinal disorders
vomiting
50.0%
1/2 • Number of events 1
Nervous system disorders
headache
50.0%
1/2 • Number of events 8
General disorders
flu like symptoms
100.0%
2/2 • Number of events 10
Respiratory, thoracic and mediastinal disorders
dyspnea
50.0%
1/2 • Number of events 1
General disorders
pain
50.0%
1/2 • Number of events 1
General disorders
fatigue
100.0%
1/1 • Number of events 1
General disorders
edema - limb
50.0%
1/2 • Number of events 1
Gastrointestinal disorders
abdominal pain
50.0%
1/2 • Number of events 1
Vascular disorders
hypotension
50.0%
1/2 • Number of events 1

Additional Information

Kristi Manjarrez, Vice President, Clinical Affairs

VentiRx Pharmaceuticals Inc.

Phone: 206-689-2259

Results disclosure agreements

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