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Castration Resistant Prostate CancerPhase 1NCT01646684

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

A Phase 1 study testing SOM230 in people with Castration Resistant Prostate Cancer, run by Novartis Pharmaceuticals at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

After failure of initial ADT, addition of an anti-androgen is established to treat castration resistant prostate cancer (CRPC). Substitution of the first anti-androgen and anti-androgen withdrawal results in treatment responses in 25-40% of patients for 4-6 months. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Castration Resistant Prostate Cancer
What is being tested?
SOM230
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
4 sitesGermany
Study dates
8 Mar 2013to 13 Nov 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ECOG 0 - 2
  • Histologically proven adenocarcinoma of the prostate.
  • Patients with CRPC (castration resistant prostate cancer): advanced or metastatic adenocarcinoma of the prostate.
  • 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 treatment.
  • 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 treatment.
  • Dose escalation part only: prior treatment with an anti-androgen and GnRH agonist or antagonist is allowed.
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  • 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).
  • Serum testosterone within castration level (<50 ng/dl or < 1,7 nM)
  • 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.

Who cannot join

  • Dose expansion part only: Secondary hormonal manipulation of prostate cancer (other than GnRH agonist or antagonist) for more than 6 weeks, including concomitant anti-androgens.
  • Prior cytotoxic therapy e.g. with docetaxel, mitoxantrone.
  • 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.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Tübingen, 72076

Other trials in Germany

About this study

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

After failure of initial ADT, addition of an anti-androgen is established to treat castration resistant prostate cancer (CRPC). Substitution of the first anti-androgen and anti-androgen withdrawal results in treatment responses in 25-40% of patients for 4-6 months. A more effective second line treatment after failure of first ADT could prolong the time until the state of symptomatic HRPC, which is currently treated with docetaxel and accompanied by significant side effects. Since the importance of the IGF-signaling in PC is not only indicated by preclinical results but also by clinical efficacy of somatostatin analogs, further clinical research with the new somatostatin analog pasireotide is warranted.

This study is designed to define the maximum tolerated dose (MTD) of pasireotide LAR in patients with castration resistant prostate cancer (CRPC). It also aims for a preliminary efficacy evaluation of pasireotide within the dose expansion part at the MTD. Preliminary efficacy will be assessed by evaluation of different measures of prostate cancer e.g. changes in PSA, disease control rate (RECIST 1.1), symptoms and changes of biomarkers linked to the mode of action of pasireotide LAR. The study will also explore characteristics of patients who might benefit most from this treatment approach

Being tested
SOM230
Keywords
Prostate cancer, pasireotide LAR, castration resistant prostatate cancer, CRPC, SOM230 LAR
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOM230Drug

Study groups in NCT01646684
Study groupRoleWhat they receive
SOM230ExperimentalNot described
Receives: Drug: SOM230

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: Day 56

  2. Expansion phase: Proportion of patients without PSA-progression at 6 months compared to baseline.

    Progression is defined as a PSA-increase of at least 25% and an absolute increase of at least 2 ng/ml from a nadir value, confirmed by a second value four weeks later.

    Measured: 6 months

Secondary outcomes (8)

  1. Incidence of adverse drug events, overall and by severity and incidence of serious adverse events and laboratory abnormalities

    Adverse events will be coded using MedDRA.

    Measured: 3 - 6 months

  2. Changes in laboratory assessments, and assessment of physical examinations such as vital signs and electrocardiograms

    Abnormalities according notable criteria (i.e., newly occurring CTC grade 3 or 4 laboratory toxicities) will be identified.

    Measured: 3 - 6 months

  3. Percentage and absolute changes from baseline values in PSA and IGF-1

    Measured: 3 - 6 months

  4. Area Under Curve (AUC)

    Measured: pre-dose, day 21 post dose

  5. Proportion of patients without progression at 6 months, defined as PSA-progression (see above) and symptomatic progression of disease and/or progression documented by imaging according to RECIST 1.1

    PSA progression is defined as an increase in PSA of at least 25% compared to baseline and an absolute increase of 2 ng/ml or more from a nadir value. Symptomatic progression is defined at the investigator's discretion. Radiological progression is assessed according to RECIST 1.1

    Measured: 6 months

  6. Median progression-free survival (PFS)

    Progression-free survival (PFS) is defined as the time from date of start of treatment to date of event defined as the first documented progression or death due to any cause.

    Measured: 3 - 6 months

  7. Median overall survival (OS)

    Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause.

    Measured: 6 - 15 months

  8. Disease Control Rate by RECIST 1.1 after 6 months

    Disease control rate (DCR) is the proportion of patients with a best overall response of CR or PR or SD.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2012 (estimated)
  2. Study start8 Mar 2013
  3. Primary completion13 Nov 2018
  4. Study completion13 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01646684
Sponsor's protocol ID
CSOM230XDE04
Other IDs
2010-024399-25
Status last verified
Oct 2019
First submitted
18 Jul 2012
Last updated
21 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SOM230 in people with Castration Resistant Prostate Cancer, run by Novartis Pharmaceuticals at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. (time frame: Day 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01646684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020; AzTrials last refreshed its copy on 1 Nov 2026.

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