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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Fulvestrant 250 mg intramuscular injection

Fulvestrant 250mg (Plus 250mg Loading Regimen)

This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.

A clinical trial to compare efficacy and tolerability of Fulvestrant 250mg, 250mg (plus 250mg Loading regimen) and 500mg

Research Site

Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg (plus 250mg Loading regimen) and 500mg in Postmenopausal Women with ER +ve Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy

An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.
Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization

Age Continuous

Gender, Male/Female

Objective Response Rate (ORR)

Time (in days) from randomization until objective disease progression or death (in the absence of objective progression).  RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 19th March 2008.

Time to Progression (TTP)

Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.

Duration of Response (DoR)

A Clinical Benefit (CB) responder is defined as a patient having a best overall response of Complete response (CR), Partial Response (PR) or Stable disease (SD) provided SD (or better) was present = 154 days from randomization (ie SD = 24 weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.

Clinical Benefit Rate (CBR)

The measure of dispersion for mean population clearance is based on the estimated inter-individual variance

Patients who agreed to participate in the PK substudy. The results are based on 148, 122 and 140 plasma-concentration records from patients in the 250 mg, 250 mg + LD and 500 mg treatment arms respectively.

Pharmacokinetic Parameter: Mean population clearance, a measure of the efficiency with which Fulvestrant is eliminated from the body

The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes

Patients who agreed to participate in the PK substudy.

Pharmacokinetic Parameter: Mean volume of distribution at steady state, a measure of the apparent volume in the body into which Fulvestrant distributes

Overall Study

8 of the 151 enrolled patients were not randomized to treatment groups for the following reasons - 8 patients were incorrectly enrolled (ie did not comply with one or more inclusion / exclusion criteria).

Arms	Assigned Interventions
Experimental: 1 Fulvestrant 250 mg intramuscular injection	Drug: Fulvestrant 250 intramuscular injection Other Name: Faslodex Other Name: ZD9238
Experimental: 2 Fulvestrant 250mg (Plus 250mg Loading Regimen)	Drug: Fulvestrant 250 intramuscular injection Other Name: Faslodex Other Name: ZD9238
Experimental: 3 Fulvestrant 500 mg	Drug: Fulvestrant 500 mg intramuscular injection

A clinical trial to compare efficacy and tolerability of Fulvestrant 250mg, 250mg (plus 250mg Loading regimen) and 500mg - FINDER I

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=406&filename=CSR-D6997C00004.pdf

CSR-D6997C00004.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator