Health TrialsbyHealthPanel

Recommended Dose Estimation of BP-C2

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-80
SponsorMeddoc

About this trial

The aim is to estimate an oral administered recommended dose of BP-C2 in addition to hormone treatment of prostate cancer.

The study population consists of prostatic cancer patients between 18 and 80 years of age undergoing hormonal treatment. Four patients will be recruited consecutively from each of two participating hospital.

The study will be performed as an open, one-dimensional multi-center trial with a 3-level within-patient Response Surface Pathway (RSP) design.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prostate cancer patients between 18 and 80 years of age under hormonal treatment

Disqualifiers

Patients with expected survival time below 3 months

Abnormal liver function classified as total bilirubin >34 µmol/l or ALAT > 3 times the upper normal range (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5 x ULN.

Abnormal kidney function defined by serum creatinine >120 µmol/l.

Patients with verified metastasis to the brain.

Trial design

Design model

Single group

Treatments tested in this trial

  • BP-C2

    Drug

    Oral daily intake

Treatment groups

8 Participants
are divided into 3 treatment groups
Group A: First design levelExperimental treatment 1 intervention
Group B: Second design levelExperimental treatment 1 intervention
Group C: Third design levelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Max CTCAE

Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Time frame
Week 0
2

Max CTCAE

Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Time frame
Week 2
3

Max CTCAE

Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Time frame
Week 4
4

Max CTCAE

Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Time frame
Week 6

Secondary outcomes

1

Quality of Life questionnaire (EQ-5D-5L)

Five score levels: "Mobility", "Self-care","Usual activity", "Pain/Discomfort", "Anxiety/Depression" and "Overall daily health situation"

Time frame
Week 0
2

Quality of Life questionnaire (EQ-5D-5L)

Five score levels: "Mobility", "Self-care","Usual activity", "Pain/Discomfort", "Anxiety/Depression" and "Overall daily health situation"

Time frame
Week 4
3

Quality of Life questionnaire (EQ-5D-5L)

Five score levels: "Mobility", "Self-care","Usual activity", "Pain/Discomfort", "Anxiety/Depression" and "Overall daily health situation"

Time frame
Week 8
4

PSA

Prostate marker

Time frame
Week 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Meddoc

Lead sponsor

Meabco A/S

Collaborator

Source ClinicalTrials.gov
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