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

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Genzyme

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Ovarian Cancer

Treatments

Drug: Vandetanib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00862836
2008-005557-38 (EudraCT Number)
D4200C00083

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

1
Experimental group
Description:
Vandetanib added to standard therapy (pegliposomal doxorubicin)
Treatment:
Drug: Vandetanib

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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