Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD) (ZACFAST)

August 29, 2016 updated by: Genzyme, a Sanofi Company

Addition of Vandetanib to Standard Therapy (Pegliposomal Doxorubicin) in Patients With Recurrent Ovarian Cancer. A Multicentre Phase I / Randomized Phase II Study

This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study. If the starting criteria for phase II of the study are met at the end of phase I, a total of approximately 20 national centers will participate in phase II of the study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Research Site
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany
        • Research Site
    • Hessen
      • Wiesbaden, Hessen, Germany
        • Research Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany
        • Research Site
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histopathologically documented invasive epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory to platinum-based chemotherapy or with partially platinum sensitive disease.
  • Planned therapy with pegylated liposomal doxorubicin 50 mg/m² for recurrent platinum-refractory ovarian cancer.
  • Patients with a progression-free-interval of 6 to 12 months after platinum-based chemotherapy are only eligible if a further course of platinum-based combination chemotherapy is not possible as judged by the investigator(s).
  • Patients must have received at least one previous platinum- and taxane-based chemotherapy regimen.

Exclusion Criteria:

  • Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
  • Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes or induce CYP3A4 function
  • Treatment with mouse-antibodies in patients with evaluable disease and CA-125 progressive disease in the last 3 months. These patients are only eligible in case of measurable disease according to RECIST or cytological/histological proven relapse
  • More than two prior lines of chemotherapy.
  • Any chemotherapy or other systemic anti-cancer therapy within four weeks prior to randomization.
  • Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Vandetanib added to standard therapy (pegliposomal doxorubicin)
Drug: Vandetanib
100mg doses orally, once daily
Other Names:
  • Zactima

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).
Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3)
From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.
Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).
From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.
Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening)
From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.
Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening).
From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.
Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake)
From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.
Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).
From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).
Time Frame: From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.
Progression Free Survival: Progression is defined using RECIST, as a measurable increase of at least 20% in the sum of longest diameters of target lesions or unequivocal progression of non-target lesions, or the appearance of new lesions, since baseline.
From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.
Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).
Time Frame: From date of registration (Informed Consent Form completed) until the date of death.
Median overall survival (OS)
From date of registration (Informed Consent Form completed) until the date of death.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (ESTIMATE)

March 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 10, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4200C00083
  • 2008-005557-38 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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