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Phase 1 Study to Evaluate Safety, and Preliminary Efficacy of Pasireotide LAR in Castration Resistant Prostate Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Castration Resistant Prostate Cancer

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Trial Information

Phase 1 Study to Evaluate Safety, and Preliminary Efficacy of Pasireotide LAR in Castration Resistant Prostate Cancer

Inclusion Criteria:

1. ECOG 0 - 2

2. Histologically proven adenocarcinoma of the prostate.

3. Patients with CRPC (castration resistant prostate cancer): advanced or metastatic
adenocarcinoma of the prostate.

4. Prior treatment with a GnRH-agonist or GnRH-antagonist for at least 6 months. The
medication must not have been changed for at least 3 months prior to start of study

5. Prior treatment with an anti-androgen (e.g. bicalutamide, flutamide,
cyproteronacetate) is allowed but not necessary. Patients treated with anti-androgen
must have discontinued anti-androgen for at least 6 weeks prior to start of study

1. Dose escalation part only: prior treatment with an anti-androgen and GnRH
agonist or antagonist is allowed.

2. Dose expansion part only: prior concomitant treatment with an anti-androgen and
GnRH agonist or GnRH antagonist for ≤6 weeks is allowed (in order to control
flare up).

6. Serum testosterone within castration level (<50 ng/dl or < 1,7 nM)

7. Disease progression demonstrated by a rising PSA with or without metastases. PSA ≥2
ng/mL at study entry. Rising PSA is defined as two consecutive rises over a nadir
value; the individual measurements are obtained at least 1 week apart.

Exclusion criteria:

1. Dose expansion part only: Secondary hormonal manipulation of prostate cancer (other
than GnRH agonist or antagonist) for more than 6 weeks, including concomitant

2. Prior cytotoxic therapy e.g. with docetaxel, mitoxantrone.

3. Patients who have received radiotherapy of target lesions. Patients who have received
local radiotherapy of non-target lesions for local symptom control within the last 4
weeks must have recovered from any adverse effects of radiotherapy before recording
baseline symptoms. Lesions treated with locoregional therapies within the last 3
months before study inclusion do not qualify as target lesions.

Additional protocol-defined inclusion/exclusion criteria apply.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Escalation phase: Frequency of dose-limiting toxicities (DLTs) at each dose level associated with monthly administration of pasireotide LAR during the first two treatment cycles by CTCAE version 4.03.

Outcome Description:

DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications as defined per study prototol. These will be evaluated according to the CTCAE v4.03.

Outcome Time Frame:

Day 56

Safety Issue:


Principal Investigator

Arnulf Stenzl, Prof. Dr. med

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitätsklinkikum Tübingen


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

March 2013

Completion Date:

February 2015

Related Keywords:

  • Castration Resistant Prostate Cancer
  • Prostate cancer, pasireotide LAR, castration resistant prostatate cancer, CRPC, SOM230 LAR
  • Prostatic Neoplasms