Trial Outcomes & Findings for Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma (NCT NCT00746590)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

every 6 weeks until progression

Results posted on

2022-07-21

Participant Flow

Participant milestones

Participant milestones
Measure	Prolarix Treatment Group Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Prolarix Treatment Group Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
Overall Study Death	1

Baseline Characteristics

Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prolarix Treatment Group n=1 Participants Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants

PRIMARY outcome

Timeframe: every 6 weeks until progression

Population: Study was terminated prematurely after only 1 patient was enrolled. The patient died one month after the initial dose of Prolarix, but his death was unrelated to Prolarix administration.

Outcome measures

Outcome measures
Measure	Prolarix Group n=1 Participants Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST	NA Proportion of patients Study was terminated--the one patient enrolled before termination died after initial dose.

SECONDARY outcome

Timeframe: Approximately 12 weeks or more after first treatment with Prolarix

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 3 weeks until progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 6 weeks until progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, every 3 weeks until progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and every 3 weeks until progression

Outcome measures

Outcome data not reported

Adverse Events

Prolarix Treatment Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prolarix Treatment Group n=1 participants at risk Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
Gastrointestinal disorders GI toxicity	100.0% 1/1 • Number of events 1 • From date of enrollment until the date of death from any cause, assessed every 21 days, up to 1 month. Study was terminated prematurely - the one patient who enrolled before termination died after their initial dose. This was not related to Prolarix administration. Other (Not Including Serious) Adverse Events were not monitored/assessed.

Other adverse events

Adverse event data not reported

Additional Information

Claire Daugherty

BTG International Ltd.

Phone: +1 801 556 8882

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place