NCT02311764

Brief Summary

Open label, non-randomised phase II clinical pilot study

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2015

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

4.8 years

First QC Date

December 2, 2014

Last Update Submit

January 22, 2020

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Response

    Soft tissue or PSA Response

    Time Frame: Up to the end of the treatment phase (ie, approximately 6 months

Secondary Outcomes (7)

  • Rate of PSA declines of ≥30%

    Time Frame: At 12 weeks and up to the end of the treatment phase (ie, approximately 6 months)

  • OS

    Time Frame: livelong follow-up

  • rPFS

    Time Frame: Up to the end of the treatment phase (ie, approximately 6 months

  • PSA

    on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months

  • Safety as per CTC AEv4.03

    on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months

  • +2 more secondary outcomes

Study Arms (1)

Carboplatin

EXPERIMENTAL

Carboplatin will be administered weekly

Drug: Carboplatin

Interventions

CarboplatinDRUG

Carboplatin will be administered weekly

Carboplatin

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written Informed Consent
  • Adult patients with histological diagnosis of adenocarcinoma of the prostate.
  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • Progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (Cyp17 inhibitor or a new generation AA like enzalutamide).
  • DNA repair defects as per central assessment
  • Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 - 2
  • Progression of disease by any of the criteria listed here:
  • PSA utilizing PCWG 2 criteria
  • Bone scan
  • RECIST 1.1
  • Adequate organ and bone marrow function as evidenced by:
  • Haemoglobin ≥8.0 g/dL
  • Absolute neutrophil count ≥1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • AST and/or ALT \< 2.5 x ULN, in the presence of liver metastases: AST ≥5 x ULN, ALT \<5 x ULN
  • +3 more criteria

You may not qualify if:

  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Carboplatin
  • Prior treatment with any prior platinum based chemotherapy,
  • Major surgery within 4 weeks prior to planned start of treatment
  • Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Previous enrolment into the current study
  • Active secondary malignancy that requires systemic therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cantonal Hospital Chur

Chur, Kanton Graubünden, 7000, Switzerland

Location

Luzern Cantonal Hospital

Lucerne, Switzerland

Location

Cantonal Hospital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Aurelius G Omlin, MD

    Cantonal Hospital of St. Gallen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 8, 2014

Study Start

February 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

CH(3)