Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD)

NCT00862836 | Terminated Phase 1 Results

• 2 other identifiers: D4200C000832008-005557-38
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Ovarian Cancer

Keywords

ZD6474; Vandetanib; Zactima; Ovarian Cancer; Phase I; Phase II; Randomized; Safety

Outcome Measures

Primary Outcomes (6)

• 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 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.

  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.

  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.

  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.

  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.

  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 Outcomes (2)

• 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).

  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).

  From date of registration (Informed Consent Form completed) until the date of death.

Study Arms (1)

1

EXPERIMENTAL

Vandetanib added to standard therapy (pegliposomal doxorubicin)

Drug: Vandetanib

Interventions

Vandetanib DRUG

100mg doses orally, once daily

Also known as: Zactima

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (5)

Research Site

Ulm, Baden-Wurttemberg, Germany

Location

Research Site

Wiesbaden, Hesse, Germany

Location

Research Site

Essen, North Rhine-Westphalia, Germany

Location

Research Site

Kiel, Schleswig-Holstein, Germany

Location

Research Site

Berlin, Germany

Location

Related Publications (1)

• Harter P, Sehouli J, Kimmig R, Rau J, Hilpert F, Kurzeder C, Elser G, du Bois A. Addition of vandetanib to pegylated liposomal doxorubicin (PLD) in patients with recurrent ovarian cancer. A randomized phase I/II study of the AGO Study Group (AGO-OVAR 2.13). Invest New Drugs. 2013 Dec;31(6):1499-504. doi: 10.1007/s10637-013-0011-3. Epub 2013 Sep 5.

  PMID: 24005613 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 17, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 10, 2016
• Results First Posted: October 11, 2012

Record last verified: 2016-08

Locations

DE (5)