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

NCT00862836 Phase 1/Phase 2 TERMINATED Results posted

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.

Details

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 1/Phase 2
Status	TERMINATED
Enrolment	15
Start date	2009-04
Completion	2010-09

Conditions

• Ovarian Cancer

Interventions

• Vandetanib

Primary outcomes

• Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). — 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)
• Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. — 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).
• 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. — 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)
• 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. — 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).
• 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. — 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)
• 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. — 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).

Countries

Germany