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Trial Outcomes & Findings for RNActive®-Derived Therapeutic Vaccine (NCT NCT00906243)

NCT ID: NCT00906243

Last Updated: 2012-04-04

Results Overview

Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0: 1. All Categories equal or greater than grade 3 2. Allergy/autoimmunity equal or greater than grade 2 3. Dosing delay greater than 48 hours due to toxicity All adverse events will be graded and documented according to Common Terminology Criteria for Adverse Events version 3.0.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

At Nine Weeks with Follow Up at One Year

Results posted on

2012-04-04

Participant Flow

A total of 6 subjects entered Phase 1 of the study between June 2009 and December 2009.

Participant milestones

Participant milestones
Measure
CV9103
CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
Overall Study
STARTED
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RNActive®-Derived Therapeutic Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CV9103
n=6 Participants
CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
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
4 Participants
n=5 Participants
Age Continuous
69.1 years
STANDARD_DEVIATION 9.58 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
Region of Enrollment
United States
6 participants
n=5 Participants

PRIMARY outcome

Timeframe: At Nine Weeks with Follow Up at One Year

Population: Phase 1 consisted of cohort 1 with 3 subjects and cohort 2 with three subjects.

Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0: 1. All Categories equal or greater than grade 3 2. Allergy/autoimmunity equal or greater than grade 2 3. Dosing delay greater than 48 hours due to toxicity All adverse events will be graded and documented according to Common Terminology Criteria for Adverse Events version 3.0.

Outcome measures

Outcome measures
Measure
CV9103
n=6 Participants
CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
Phase I: Assessment of Safety and Tolerability of the Trial Regimen
6 events

Adverse Events

CV9103

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
CV9103
n=6 participants at risk
CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
General disorders
Erythema
100.0%
6/6 • Number of events 6
General disorders
Induration
100.0%
6/6 • Number of events 6
General disorders
Fatigue
33.3%
2/6 • Number of events 2
General disorders
Influenza Like Illness
16.7%
1/6 • Number of events 1
General disorders
Oedema Peripheral
16.7%
1/6 • Number of events 1
Musculoskeletal and connective tissue disorders
Myalgia
33.3%
2/6 • Number of events 2
Musculoskeletal and connective tissue disorders
Arthraligia
16.7%
1/6 • Number of events 1
Musculoskeletal and connective tissue disorders
Back Pain
16.7%
1/6 • Number of events 1
Nervous system disorders
Headache
33.3%
2/6 • Number of events 2
Nervous system disorders
Peripheral motorneuropathy
16.7%
1/6 • Number of events 1
Endocrine disorders
Hypothyroidism
16.7%
1/6 • Number of events 1
Gastrointestinal disorders
Constipation
16.7%
1/6 • Number of events 1
Infections and infestations
Oral Fungal Infection
16.7%
1/6 • Number of events 1
Infections and infestations
Rhinitis
16.7%
1/6 • Number of events 1
Investigations
Weight Decreased
16.7%
1/6 • Number of events 1
Metabolism and nutrition disorders
Anorexia
16.7%
1/6 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Cough
16.7%
1/6 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Ordpharyngeal pain
16.7%
1/6 • Number of events 1
Skin and subcutaneous tissue disorders
Pruitus
16.7%
1/6 • Number of events 1
Skin and subcutaneous tissue disorders
Rash
16.7%
1/6 • Number of events 1
Surgical and medical procedures
Skin Neopasm Excision
16.7%
1/6 • Number of events 1

Additional Information

Dr. Johannes Vieweg

University of Florida

Phone: 352 273-6815

Results disclosure agreements

  • Principal investigator is a sponsor employee This was a Phase 1 and Phase 2 study. The study was terminated after completion of Phase 1 under terms of a settlement agreement that restricts disclosure to limited Phase 1 results only.
  • Publication restrictions are in place

Restriction type: OTHER