Trial · Interventional

CompletedPhase 3Results postedRegistry data

Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer

NCTNCT01656161Other idDebio 8206-SC-301Other idKRA75538

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 120 participants (actual)
Sponsor: Debiopharm International SA · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
South Africa
Start: Jul 2012
Primary completion: Aug 2013
Completion: Aug 2013
First posted: 2 Aug 2012 (estimated)
Last update posted: 15 Sept 2015 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201220132014

Ph 3
Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer
NCT01656161
Jul 2012 to Aug 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in: * achieving castrate levels of testosterone (\< 1.735 nmol/L) on Day 29 \[i.e., 28 days after investigational medicinal product (IMP) injection\], and * in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.

Interventions

Triptorelin embonate 22.5 mgDrug

Arms1

Experimental
Triptorelin embonate 22.5 mg
Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)
Time frame · within 337 days

Secondary outcomes(10)

Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169
Time frame · on Days 1 and 169
Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337
Time frame · Baseline through Day 337
Number of Participants Who Presented a Real "Acute-on-chronic" (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)
Time frame · Day 171
Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)
Time frame · Days 1-169
Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)
Time frame · Days 1-169
Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)
Time frame · Days 1-169
Testosterone PD Metrics for First Injection: Time to Castration (Tcast)
Time frame · Days 1-169
Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)
Time frame · Days 1-169 and Days 169-337
Triptorelin PK Metrics for Both Injections: Cmax
Time frame · Days 1-169 and Days 169-337
Triptorelin PK Metrics for Both Injections: Concentration 0 Hour
Time frame · Days 1-169 and Days 169-337

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· within 337 days

Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)

Group	Value (Percentage of Participants)
Triptorelin Embonate 22.5 mg	98.33

Secondary and other outcome results(7)

Secondary outcomeNumber· on Days 1 and 169

Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169

Group	Value (percentage of participants)
Triptorelin Embonate 22.5 mg	0.85

Secondary outcomeMean· Baseline through Day 337

Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337

Group	Value (percentage of change in PSA levels)	Spread
Triptorelin Embonate 22.5 mg	-83.20	38.10

Secondary outcomeNumber· Day 171

Number of Participants Who Presented a Real "Acute-on-chronic" (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)

Group	Value (participants)
Triptorelin Embonate 22.5 mg	1

Secondary outcomeGeometric mean· Days 1-169

Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)

Group	Value (day*nmol/L)
PK/PD Subset	224.13

Secondary outcomeGeometric mean· Days 1-169

Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)

Group	Value (nmol/L)
PK/PD Subset	16.52

Secondary outcomeMedian· Days 1-169

Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)

Group	Value (hours)	Spread
PK/PD Subset	48	40.02

Secondary outcomeGeometric mean· Days 1-169

Testosterone PD Metrics for First Injection: Time to Castration (Tcast)

Group	Value (days)
PK/PD Subset	18.01

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Triptorelin Embonate 22.5 mgParticipants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.	–	17 / 120	117 / 120

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2007

2 results

Population pharmacokinetic/pharmacodynamic (PK/PD) modelling of the hypothalamic-pituitary-gonadal axis following treatment with GnRH analogues.

Tornøe et al. 2007British journal of clinical pharmacologycited by 29

PMID 17096678PMC2000597DOI 10.1111/j.1365-2125.2006.02820.xPUB-17096678

Rights unknown2 results

Source link See results (2)

More studies

1 study on this page

PubMed tag: none · 1999

[Effectiveness and tolerance of 1 dosage forms (subcutaneous and intramuscular) of decapeptyl depot in patients with advanced prostate carcinoma].

Klippel et al. 1999Der Urologe. Ausg. Acited by 2

PMID 10407987DOI 10.1007/s001200050280PUB-10407987

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Male
Age: Not stated
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Summary Inclusion Criteria: * Meets protocol-specified criteria for qualification and contraception * Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications * Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures Summary Exclusion Criteria: * Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters * Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results

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