search
Back to results

Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)

Primary Purpose

Bladder Carcinoma in Situ (CIS)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
Sponsored by
Fidia Farmaceutici s.p.a.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Carcinoma in Situ (CIS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Willing and able to freely provide written informed consent (in presence of an Independent Witness if applicable) prior to performing study procedures.
  2. Age 18 years or older, male or female.
  3. Persistent or recurrent histologically confirmed CIS of the bladder with or without concomitant Ta-T1 and with no evidence of metastases demonstrated by abdominal CT scan.
  4. "BCG unresponsive" patients who refuse radical cystectomy or are not clinically suitable for cystectomy. BCG unresponsive disease includes BCG refractory (persistent high-grade disease at 6 months despite adequate BCG treatment) and BCG relapsing (recurrence of high-grade disease after achieving a disease-free state at 6 months after adequate BCG). Patients can be within 6 to 9 months of the last BCG exposure, thereby allowing a 3-month lead time for referral.

    Adequate BCG therapy is defined as at least one of the following:

    • At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy.
    • At least five of six doses of an initial induction course plus at least two of six doses of a second induction course.
  5. Complete resection of Ta-T1 papillary lesions before entering the trial in patients with concomitant CIS and papillary tumors (residual CIS acceptable).
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  7. Adequate organ function: absolute neutrophil count ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 10.0 g/dL, ALT/AST ≤ 5 x upper limit of normal (ULN), alkaline phosphatase ≤ 5 x ULN, total serum bilirubin ≤ 1.5 x ULN, serum creatinine ≤ 2.2 mg/dL.
  8. Female in non-reproductive years (defined as surgically sterile or one year postmenopausal). Female of childbearing potential must agree to practice complete abstinence or agree to use highly effective contraceptive methods, which include:

    • Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject.
    • Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception.

    Male patients must be surgically sterile or willing to use a double barrier contraception method upon enrollment, during the course of the study, and for 1 month following the last study drug infusion.

  9. Able and willing to comply with the scheduled visits, therapy plans, and laboratory tests required in this protocol.

Exclusion Criteria:

  1. Current or previous muscle-invasive disease (T2-T4) or metastatic urothelial carcinoma.
  2. Suspected hypersensitivity to paclitaxel or to any of the Oncofid-P-B constituents.
  3. Previous or concomitant cancer of the upper urinary tract or the prostatic urethra. Freedom from upper tract disease must be demonstrated by intravenous pyelogram, retrograde pyelogram, CT scan or MRI.
  4. Current or prior systemic therapy for bladder cancer.
  5. Intravesical therapy within 4 weeks prior to beginning study treatment with the exception of cytotoxic agents (e.g. mitomycin C, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure between 14 to 60 days prior to beginning study treatment, or previous intravesical BCG therapy, which can be given at least 5 weeks before the diagnostic biopsy required for study entry.
  6. Symptomatic urinary tract infection or bacterial cystitis. Once successfully treated (negative urine culture), patients may enter the study.
  7. Major surgery, other than diagnostic, within 4 weeks prior to treatment.
  8. Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri.
  9. Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s) (e.g., uncontrolled cardiac or respiratory disorders).
  10. Presence of significant urologic disease interfering with intravesical therapy.
  11. Current enrollment or participation in another therapeutic clinical trial within 3 months preceding treatment start.
  12. Known substance and/or alcohol abuse.
  13. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry in this study or could compromise protocol objectives.
  14. Pregnancy, lactating women or women of childbearing potential unwilling to use adequate birth control measures for the duration of the study and until 3 months after the end of treatment.
  15. Subjects who have a mean QTc >480 msec at baseline and who need concomitant medications which may cause QT prolongation.

Sites / Locations

  • Ochsner Clinic FoundationRecruiting
  • Johns Hopkins Kimmel Cancer CenterRecruiting
  • CHU de Clermont-Ferrand - Hopital Gabriel MontpiedRecruiting
  • CHU de Lille - Hopital Claude HuriezRecruiting
  • Institute Paoli-CalmettesRecruiting
  • AP-HP Hopital TenonRecruiting
  • AP-HP Hopital Bichat-Claude BernardRecruiting
  • Centre Hospitalier Universitaire PoitiersRecruiting
  • Istituto Oncologico Veneto-I.R.C.C.S.-Ospedale San GiacomoRecruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaRecruiting
  • IRCSS Ospedale San RaffaeleRecruiting
  • Istituto Clinico HumanitasRecruiting
  • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo TrentoRecruiting
  • Wojewodzki Szpital im Sw. Ojca Pio w Przemyslu, Oddzial Urologiczny z Pododdzialem Urologii OnkologicznejRecruiting
  • Hospital Universitario de BasurtoRecruiting
  • Vall d'Hebron Barcelona HospitalRecruiting
  • Hospital Clinic BarcelonaRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Hospital Universitario Virgen de las NievesRecruiting
  • Centro Integral Oncologico Clara CampalRecruiting
  • Hospital Fundación Jimenez DiazRecruiting
  • Hospital Universitario Fundacion AlcorconRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Instituto Valenciano de OncologiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)

Arm Description

Outcomes

Primary Outcome Measures

Centrally assessed Complete Response Rate (CRR) - end of induction phase
CRR calculated as the proportion of patients achieving a CR after 12 weekly intravesical instillations (end of induction phase). CRR will be based on central assessment of response

Secondary Outcome Measures

Centrally assessed CRR
CRR calculated as the proportion of patients achieving a CR at 6, 9, 18 and 24 months after treatment start
Duration of Response (DoR)
DoR defined as the time from first documented evidence of CR to time of documented recurrence (CIS or Ta-T1), progression to higher grade (MIBC), to extravesical disease or death
Duration of Response (DoR) rate
DoR rate calculated as the proportion of patients who maintained a CR after 6, 9, 12, 15, 18, 21 and 24 months after treatment start.
Progression rate
Progression rate calculated as the proportion of patients with muscle invasion or extravesical expansion of the disease at 3, 15 and 24 months after treatment start
Time to progression
Time to progression defined as time from treatment start to time of documented tumor progression to MIBC or extravesical disease.
Rate of patients undergoing cystectomy
Proportion of patients undergoing cystectomy for disease progression at 3 months (end of induction phase), 15 and 24 months after treatment start.
event-free survival (EFS)
EFS defined as time from treatment start to the time of documented recurrence after CR, or progression or death due to any cause.
Overall survival (OS)
OS defined as time from treatment start to death due to any cause.
Incidence of Treatment-Emergent Adverse Events (Overall Safety)
Overall safety and tolerability evaluated throughout the study on the basis of the incidence, nature, severity and causality of TEAEs, coded to preferred term and system organ class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA) and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5 and the incidence of serious adverse events (SAEs)
Treatment time of retention (tolerability)
The tolerability of ONCOFID-P-B expressed as the ability to retain intravesical instillation for the desired dwell time (120 minutes) and measured as time of retention.

Full Information

First Posted
August 20, 2021
Last Updated
October 9, 2023
Sponsor
Fidia Farmaceutici s.p.a.
search

1. Study Identification

Unique Protocol Identification Number
NCT05024773
Brief Title
Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
Official Title
Phase III, Single-arm Study to Evaluate the Efficacy and Safety of ONCOFID-P-B (Paclitaxel-hyaluronic Acid Conjugate) Administered Intravesically to Patients With BCG-unresponsive Carcinoma in Situ of the Bladder With or Without Ta-T1 Papillary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fidia Farmaceutici s.p.a.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-P-B following intravesical instillation in adult patients with histologically and cytologically confirmed CIS, with or without concomitant Ta-T1, who are unresponsive to BCG therapy and unwilling or unfit to undergo radical cystectomy. After providing written informed consent (in presence of an Independent Witness, if applicable), patients will receive an induction therapy consisting of 12 weekly intravesical instillations of ONCOFID-P-B (induction phase). Patients who achieve a CR by Investigator assessment at the end of the induction phase will enter the maintenance phase and receive monthly treatment for an additional 12 months or until recurrence of CIS/Ta-T1 or progression to MIBC or extravesical disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Carcinoma in Situ (CIS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
Intervention Description
Schedule: once a week for 12 consecutive weeks (induction therapy). Patients who achieve a complete response at the end of the induction phase will enter the maintenance phase, during which ONCOFID-P-B is administered once a month for 12 months until recurrence or progression of the disease.
Primary Outcome Measure Information:
Title
Centrally assessed Complete Response Rate (CRR) - end of induction phase
Description
CRR calculated as the proportion of patients achieving a CR after 12 weekly intravesical instillations (end of induction phase). CRR will be based on central assessment of response
Time Frame
CRR will be evaluated at the end of the induction phase, at 12 weeks
Secondary Outcome Measure Information:
Title
Centrally assessed CRR
Description
CRR calculated as the proportion of patients achieving a CR at 6, 9, 18 and 24 months after treatment start
Time Frame
CRR will be evaluated at 6, 9, 18 and 24 months after treatment start
Title
Duration of Response (DoR)
Description
DoR defined as the time from first documented evidence of CR to time of documented recurrence (CIS or Ta-T1), progression to higher grade (MIBC), to extravesical disease or death
Time Frame
DoR will be evaluated at any time during the study up to 24 months after treatment start
Title
Duration of Response (DoR) rate
Description
DoR rate calculated as the proportion of patients who maintained a CR after 6, 9, 12, 15, 18, 21 and 24 months after treatment start.
Time Frame
DoR rates will be evaluated at 6, 9, 12, 15, 18, 21 and 24 after treatment start
Title
Progression rate
Description
Progression rate calculated as the proportion of patients with muscle invasion or extravesical expansion of the disease at 3, 15 and 24 months after treatment start
Time Frame
Progression rate will be evaluated at 3, 15 and 24 months after treatment start
Title
Time to progression
Description
Time to progression defined as time from treatment start to time of documented tumor progression to MIBC or extravesical disease.
Time Frame
Time to progression will be evaluated at any time during the study up to 24 months after treatment start
Title
Rate of patients undergoing cystectomy
Description
Proportion of patients undergoing cystectomy for disease progression at 3 months (end of induction phase), 15 and 24 months after treatment start.
Time Frame
Rate of patients undergoing cystectomy will be evaluated at 3 months (end of induction phase), 15 and 24 months after treatment start.
Title
event-free survival (EFS)
Description
EFS defined as time from treatment start to the time of documented recurrence after CR, or progression or death due to any cause.
Time Frame
event-free survival (EFS) will be evaluated at any time during the study up to 24 months after treatment start
Title
Overall survival (OS)
Description
OS defined as time from treatment start to death due to any cause.
Time Frame
overall survival (OS) will be evaluated at any time during the study up to 24 months after treatment start
Title
Incidence of Treatment-Emergent Adverse Events (Overall Safety)
Description
Overall safety and tolerability evaluated throughout the study on the basis of the incidence, nature, severity and causality of TEAEs, coded to preferred term and system organ class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA) and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5 and the incidence of serious adverse events (SAEs)
Time Frame
Safety data will be evaluated up to 16 months
Title
Treatment time of retention (tolerability)
Description
The tolerability of ONCOFID-P-B expressed as the ability to retain intravesical instillation for the desired dwell time (120 minutes) and measured as time of retention.
Time Frame
Tolerability will be evaluated up to 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to freely provide written informed consent (in presence of an Independent Witness if applicable) prior to performing study procedures. Age 18 years or older, male or female. Persistent or recurrent histologically confirmed CIS of the bladder with or without concomitant Ta-T1 and with no evidence of metastases demonstrated by abdominal CT scan. "BCG unresponsive" patients who refuse radical cystectomy or are not clinically suitable for cystectomy. BCG unresponsive disease includes BCG refractory (persistent high-grade disease at 6 months despite adequate BCG treatment) and BCG relapsing (recurrence of high-grade disease after achieving a disease-free state at 6 months after adequate BCG). Patients can be within 6 to 9 months of the last BCG exposure, thereby allowing a 3-month lead time for referral. Adequate BCG therapy is defined as at least one of the following: At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy. At least five of six doses of an initial induction course plus at least two of six doses of a second induction course. Complete resection of Ta-T1 papillary lesions before entering the trial in patients with concomitant CIS and papillary tumors (residual CIS acceptable). Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Adequate organ function: absolute neutrophil count ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 10.0 g/dL, ALT/AST ≤ 5 x upper limit of normal (ULN), alkaline phosphatase ≤ 5 x ULN, total serum bilirubin ≤ 1.5 x ULN, serum creatinine ≤ 2.2 mg/dL. Female in non-reproductive years (defined as surgically sterile or one year postmenopausal). Female of childbearing potential must agree to practice complete abstinence or agree to use highly effective contraceptive methods, which include: Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject. Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. Male patients must be surgically sterile or willing to use a double barrier contraception method upon enrollment, during the course of the study, and for 1 month following the last study drug infusion. Able and willing to comply with the scheduled visits, therapy plans, and laboratory tests required in this protocol. Exclusion Criteria: Current or previous muscle-invasive disease (T2-T4) or metastatic urothelial carcinoma. Suspected hypersensitivity to paclitaxel or to any of the Oncofid-P-B constituents. Previous or concomitant cancer of the upper urinary tract or the prostatic urethra. Freedom from upper tract disease must be demonstrated by intravenous pyelogram, retrograde pyelogram, CT scan or MRI. Current or prior systemic therapy for bladder cancer. Intravesical therapy within 4 weeks prior to beginning study treatment with the exception of cytotoxic agents (e.g. mitomycin C, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure between 14 to 60 days prior to beginning study treatment, or previous intravesical BCG therapy, which can be given at least 5 weeks before the diagnostic biopsy required for study entry. Symptomatic urinary tract infection or bacterial cystitis. Once successfully treated (negative urine culture), patients may enter the study. Major surgery, other than diagnostic, within 4 weeks prior to treatment. Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri. Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s) (e.g., uncontrolled cardiac or respiratory disorders). Presence of significant urologic disease interfering with intravesical therapy. Current enrollment or participation in another therapeutic clinical trial within 3 months preceding treatment start. Known substance and/or alcohol abuse. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry in this study or could compromise protocol objectives. Pregnancy, lactating women or women of childbearing potential unwilling to use adequate birth control measures for the duration of the study and until 3 months after the end of treatment. Subjects who have a mean QTc >480 msec at baseline and who need concomitant medications which may cause QT prolongation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Giordan
Phone
+390498232512
Email
ngiordan@fidiapharma.it
Facility Information:
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohith Arcot, MD
Facility Name
Johns Hopkins Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max Kates, MD
Facility Name
CHU de Clermont-Ferrand - Hopital Gabriel Montpied
City
Clermont-Ferrand
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Guy, MD
Facility Name
CHU de Lille - Hopital Claude Huriez
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gautier Marcq, MD
Facility Name
Institute Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pignot Geraldine, MD
Facility Name
AP-HP Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Traxer, MD
Facility Name
AP-HP Hopital Bichat-Claude Bernard
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evanguelos Xylinas, MD
Facility Name
Centre Hospitalier Universitaire Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Bernardeu, MD
Facility Name
Istituto Oncologico Veneto-I.R.C.C.S.-Ospedale San Giacomo
City
Castelfranco Veneto
State/Province
Padova
ZIP/Postal Code
31033
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Porreca, MD
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Chessa, MD
Facility Name
IRCSS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Moschini, MD
Facility Name
Istituto Clinico Humanitas
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodolfo Hurle, MD
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Antonelli, MD
Facility Name
Wojewodzki Szpital im Sw. Ojca Pio w Przemyslu, Oddzial Urologiczny z Pododdzialem Urologii Onkologicznej
City
Przemyśl
ZIP/Postal Code
37-700
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafał Walczak, MD
Facility Name
Hospital Universitario de Basurto
City
Bilbao
State/Province
Bizkaia
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ainara Rabade Ferreiro, MD
Facility Name
Vall d'Hebron Barcelona Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Xavier Raventós Busquets, MD
Facility Name
Hospital Clinic Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ribal Caparros, MD
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garcia Rubio Jose Horacio, MD
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Vàzquez Alonso, MD
Facility Name
Centro Integral Oncologico Clara Campal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Guerrero Ramos, MD
Facility Name
Hospital Fundación Jimenez Diaz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Ignacio Monzo Gardiner, MD
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Llorente, MD
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Sáez Barranquero, MD
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose L Dominguez-Escrig, MD

12. IPD Sharing Statement

Learn more about this trial

Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)

We'll reach out to this number within 24 hrs