ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial

NCT00752986 | Terminated Phase 2 Results

• 2 other identifiers: D4200L00009EUDRACT 2008-000579-12
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 11

Brief Summary

The primary objective is to assess the event-free survival defined as the time from randomisation to progression, death without progression, loss to follow up, whichever occurred first..

Conditions

Breast Cancer

Keywords

ZD6474; Vandetanib; Zactima; Fulvestrant; Faslodex; Breast Cancer; Advanced, Metastatic; Hormone Receptor Positive; Post-Menopausal Patients; post-menopausal women with hormone receptor positive advanced breast cancer

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

  Success rate (patients without progression and still on treatment at 24 weeks

  Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.

Secondary Outcomes (3)

• Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)

  Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.

• Overall Survival

  Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.

• Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes

  Continuous assessment of safety.

Study Arms (3)

Vandetanib at the dose of 100 mg

EXPERIMENTAL

vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)

Drug: ZD6474 (Vandetanib at the dose of 100 mg); Drug: Fulvestrant; Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)

Vandetanib at the dose of 300 mg

EXPERIMENTAL

vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)

Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg); Drug: Fulvestrant; Drug: ZD6474 (Vandetanib at the dose of 300 mg)

Placebo to match vandetanib 100 mg and 300 mg

PLACEBO COMPARATOR

placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).

Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg); Drug: Fulvestrant; Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)

Interventions

ZD6474 (Vandetanib at the dose of 100 mg) DRUG

100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Also known as: Zactima

Vandetanib at the dose of 100 mg

Placebo to match ZD6474 (Vandetanib at the dose of 100 mg) DRUG

Placebo of 300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Placebo to match vandetanib 100 mg and 300 mg; Vandetanib at the dose of 300 mg

Fulvestrant DRUG

All patients will receive fulvestrant Loading Dose (LD). The Loading Dose regimen is 500mg (2 injections) at day 1, followed by 250mg at day 14, 28 and every 28 days thereafter.

Also known as: Faslodex

Placebo to match vandetanib 100 mg and 300 mg; Vandetanib at the dose of 100 mg; Vandetanib at the dose of 300 mg

ZD6474 (Vandetanib at the dose of 300 mg) DRUG

300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first.

Also known as: Zactima

Vandetanib at the dose of 300 mg

Placebo to match ZD6474 (Vandetanib at the dose of 300 mg) DRUG

Placebo of 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Placebo to match vandetanib 100 mg and 300 mg; Vandetanib at the dose of 100 mg

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post menopausal women with locally advanced or metastatic breast cancer
• Patients may have either measurable or non-measurable disease, as defined by RECIST criteria
• One previous hormone therapy or one previous chemotherapy for advanced disease are allowed (patients who have stable but evident disease after chemotherapy are eligible)
• estrogen receptor positive ER+ and/or progesterone receptor positive PR+ on primary or secondary tumour

You may not qualify if:

• Hormone receptor negative tumours (ER and PR negative)
• Presence of life-threatening metastatic visceral disease
• Significant cardiovascular event (e.g. myocardial infarction, superior vena cava \[SVC\] syndrome, New York Heart Association \[NYHA\] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
• History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (11)

Research Site

Avellino, Italy

Location

Research Site

Benevento, Italy

Location

Research Site

Genova, Italy

Location

Research Site

Milan, Italy

Location

Research Site

Monserrato, Italy

Location

Research Site

Napoli, Italy

Location

Research Site

Palermo, Italy

Location

Research Site

Prato, Italy

Location

Research Site

Roma, Italy

Location

Research Site

Trento, Italy

Location

Research Site

Varese, Italy

Location

Related Publications (1)

• Ciardiello F, Caputo R, Damiano V, Caputo R, Troiani T, Vitagliano D, Carlomagno F, Veneziani BM, Fontanini G, Bianco AR, Tortora G. Antitumor effects of ZD6474, a small molecule vascular endothelial growth factor receptor tyrosine kinase inhibitor, with additional activity against epidermal growth factor receptor tyrosine kinase. Clin Cancer Res. 2003 Apr;9(4):1546-56.

  PMID: 12684431 BACKGROUND

Related Links

• D4200L00009\_Clinical\_Report\_Synopsis

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

vandetanib; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 16, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 5, 2016
• Results First Posted: October 6, 2014

Record last verified: 2016-10

Locations

IT (11)