A Study to Evaluate the Effects of Combining Cabazitaxel With Cisplatin Given Every 3 Weeks in Patients With Advanced Solid Cancer
A Dose-Escalation Study Of The Safety, Tolerability, And Pharmacokinetics Of Cabazitaxel In Combination With Cisplatin Administered Every 3 Weeks In Subjects With Advanced Solid Malignancies
This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment, crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively).
There are 4 parts to the study:
Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based on safety.
Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated Dose (MTD) in an extended cohort of patients.
Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the pharmacokinetic (PK) of Cabazitaxel.
Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic (PK) of Cabazitaxel.
調査の概要
詳細な説明
The total duration on the study per subject will be about 26 weeks broken down as follows:
- A maximum of 21-day screening phase,
- 21-days (+/- 2 weeks) study treatment cycles,
- 30-day follow-up visit after the last dose of study medication.
- Cut-off date for parts 1, 2, 3 and 4: when the last patient has completed 6 cycles (parts 1 and 2) or 2 cycles (parts 3 and 4) of treatment or discontinued study treatment (for disease progression, unacceptable toxicity, withdrawal of consent, or investigator's decision to withdraw), whichever comes first, in the corresponding part.
Patients still receiving treatment at the cut-off date may continue to receive treatment beyond the cut-off date at investigator's discretion if benefiting.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90048
- Investigational Site Number 840008
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San Diego、California、アメリカ、92123
- Investigational Site Number 840003
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Illinois
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Decatur、Illinois、アメリカ、62526
- Investigational Site Number 840010
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Maryland
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Baltimore、Maryland、アメリカ、21201
- Investigational Site Number 840002
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Missouri
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St Louis、Missouri、アメリカ、63110
- Investigational Site Number 840006
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Ohio
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Cincinnati、Ohio、アメリカ、45267-0542
- Investigational Site Number 840007
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Texas
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San Antonio、Texas、アメリカ、78229
- Investigational Site Number 840005
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
- confirmed metastatic or unremovable advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, but for which cisplatin based therapy is appropriate
- signed informed consent
Exclusion criteria
- limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
- inability to follow study requirements and schedule
- treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other cancer therapy
- serious medical illness at same time of study and/or significantly abnormal lab reports
- lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
- Women of childbearing potential not protected by highly effective contraceptive method of birth control OTHER than hormonal contraception (Part 4 only).
- prior significant hearing or kidney problems
- continued toxic effects of prior chemotherapy
- cancers that cannot be physically measured (Part 2 only)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：1
|
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)
時間枠：first cycle (i.e.3 weeks)
|
first cycle (i.e.3 weeks)
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Objective response ratio (Complete response (CR) and partial response (PR)) (part 2)
時間枠：up to 6 cycles, ie 18 weeks
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up to 6 cycles, ie 18 weeks
|
|
Pharmacokinetics (PK) of cabazitaxel (part 3 and 4)
時間枠：up to 6 cycles, ie 18 weeks
|
up to 6 cycles, ie 18 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Time to progression (TTP) (part 1 and 2)
時間枠：up to 6 cycles, ie 18 weeks
|
up to 6 cycles, ie 18 weeks
|
|
Duration of response (DR) (Part 1 and 2)
時間枠：up to 6 cycles, ie 18 weeks
|
up to 6 cycles, ie 18 weeks
|
|
Cabazitaxel pharmacokinetic (part 1 and 2)
時間枠：up to 6 cycles, ie 18 weeks
|
up to 6 cycles, ie 18 weeks
|
協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- TCD10870
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。