ゾメタ® 注射液 ４mg
‐多発性骨髄腫による骨病変及び固形癌骨転移による骨病変‐
CTD 第 2 部
2.1
CTD の目次(第 2 部から第 5 部)
Page 2
CTD 2.1 目次
2
第2部
表
2.1
題
CTD の目次(第２部から第５部)
巻番号
仕切り番号
2
2.1
2.2
緒言
2
2.2
2.3
品質に関する概括資料
2
2.3
該当資料なし
2.4
非臨床試験の概括評価
2
2.4
2.5
臨床に関する概括評価
2
2.5
2.6
非臨床試験の概要文及び概要表
2
2.6
2.6.1 緒言
2
2.6.1
2.6.2/3 薬理試験の概要文/概要表
2
2.6.2/3
2.6.4/5 薬物動態試験の概要文/概要表
2
2.6.4/5
該当資料なし
2.6.6/7 毒性試験の概要文/概要表
2
2.6.6/7
該当資料なし
2.7
3
臨床概要
第3部
【該当資料なし】
2
2.7
Page 3
CTD 2.1 目次
4
第4部
表
題
巻番号 仕切り番号
4.1
目次
3
4.1
4.2
非臨床試験報告書／緒言
3
4.2
3
4.2.1
3
4.2.1.1
3
4.2.1.1 - 1
3
4.2.1.2
4.2.1
薬理試験
4.2.1.1
効力を裏付ける試験
Effects of zoledronic acid on the bone destruction induced
by human prostate cancer, PC-3MM2, cells injected into bone
4.2.1.2
副次的薬理試験
該当資料なし
4.2.1.3
安全性薬理試験
3
4.2.1.3
該当資料なし
4.2.1.4
薬力学的薬物相互作用試験
3
4.2.1.4
該当資料なし
4.2.2
薬物動態試験
3
4.2.2
該当資料なし
4.2.3
毒性試験
3
4.2.3
該当資料なし
4.3
参考文献
Zoledronic acid exhibits inhibitory effects on osteoblastic
and osteolytic metastases of prostate cancer.
Clin Cancer Res, 9: p295-306 (2003)
3
4.3
3
4.3 - 1
Page 4
CTD 2.1 目次
第5部
表
題
巻番号
仕切り番号
5.1
目次
3
5.1
5.2
臨床試験一覧表
3
5.2
5.3
試験報告書及び関連情報
3
5.3
生物薬剤学試験報告書
3
5.3.1
5.3.1
該当資料なし
5.3.2
ヒト生体試料を用いた薬物動態関連の試験報告書
3
5.3.2
該当資料なし
5.3.3
臨床薬物動態(PK)試験報告書
3
5.3.3
「悪性腫瘍による高カルシウム血症」申請時提出済み
5.3.4
臨床薬力学(PD)試験報告書
3
5.3.4
該当資料なし
5.3.5
有効性及び安全性試験報告書
Double-blind, randomized, dose ranging, safety and efficacy
trial of rapid intravenous infusion of zoledronate vs.
Aredia in cancer patients with osteolytic bone metastases
(Study No.007)
3
5.3.5
3
5.3.5-1
4
5.3.5-2
5
5.3.5-3
6
5.3.5-4
Cancer, 91: p1191-1200 (2001)
A randomized, double-blind, multi-center, comparative trial
of i.v. zoledronate (4 or 8mg) versus i.v. Aredia (90mg),
as an adjunct to standard therapies, in the treatment of
multiple myeloma and breast cancer patients with cancerrelated bone lesions (Study No.4244603010)
Cancer J, 7: p377-387 (2001)
A randomized, double-blind, placebo-controlled, multicenter
trial to evaluate the safety and efficacy of zoledronic
acid (4 and 8mg) administered intravenously as an adjuvant
to anticancer therapy to patients with any cancer with bone
metastases other than breast cancer, multiple myeloma or
prostate cancer (Study No.4244603011)
J Clin Oncology, 21: p3150-3157(2003)
A randomized, double-blind, placebo-controlled,
multicenter, comparative, safety and efficacy study of
intravenous zoledronate (4mg and 8mg) in prostate cancer
patients with metastatic bone lesions receiving
antineoplastic therapy (Study No.CGP42446-03-039)
J National Cancer Institute, 94: p1458-1468 (2002)
Page 5
CTD 2.1 目次
表
題
CGP42446 注射剤の乳癌骨転移患者を対象とした二重盲検群間比較
試験‐治験総括報告書‐
Open-label, fixed ascending, dose ranging, safety trial of
rapid intravenous infusion of CGP42446 in cancer patients
with osteolytic bone metastases (Study No.003)
巻番号
仕切り番号
7
5.3.5-5
7
5.3.5-6
8
5.3.5-7
9
5.3.5-8
10
5.3.5-9
11
5.3.6
11
5.3.6-1
11
5.3.6-2
11
5.3.6-3
11
5.3.6-4
11
5.3.6-5
11
5.3.6-6
11
5.3.7
11
5.3.7-1
Clin Cancer Res, 7: p478-485 (2001)
A randomized, double-blind, multi-center, comparative trial
of i.v. zoledronate (4 or 8mg) versus i.v. Aredia (90mg),
as an adjunct to standard therapies, in the treatment of
multiple myeloma and breast cancer patients with cancerrelated bone lesions (Study No.42446-03-010 core and
extension)
Cancer, 98: p1735-1744 (2003)
A randomized, double-blind, placebo-controlled, multicenter
trial to evaluate the safety and efficacy of zoledronic
acid (4 and 8mg) administered intravenously as an adjuvant
to anticancer therapy to patients with any cancer with bone
metastases other than breast cancer, multiple myeloma or
prostate cancer (Study No.42446-03-011 core and extension)
A randomized, double-blind, placebo-controlled,
multicenter, comparative, safety and efficacy study of
intravenous zoledronate (4mg and 8mg) in prostate cancer
patients with metastatic bone lesions receiving
antineoplastic therapy (Study No.CGP42446-03-039 core and
extension)
5.3.6 市販後の使用経験に関する報告書
PERIODIC SAFETY UPDATE REPORT (PSUR 1)
From July 1,1999 to February 28,2001
PERIODIC SAFETY UPDATE REPORT (PSUR 2)
From 01 March 2001 to 31 August 2001
PERIODIC SAFETY UPDATE REPORT (PSUR 3)
From 01 September 2001 to 28 February 2002
PERIODIC SAFETY UPDATE REPORT (PSUR 4)
Period covered by this report: 01-Mar-2002-31-Aug-2002
PERIODIC SAFETY UPDATE REPORT (PSUR 5)
Period covered by this report: 01-Sep-2002-31-Aug-2003
PERIODIC SAFETY UPDATE REPORT (PSUR 7)
Period covered by this report: 01-Sep-2004-31-Aug-2005
5.3.7
患者データ一覧表及び症例記録
国内第Ⅱ相試験 1501（症例一覧表，副作用一覧表，臨床検査値異
常変動症例一覧表，臨床検査値推移図）

1

2.6.4/5 薬物動態試験の概要文／概要表