Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
Ph IIb Study Evaluating the Safety & Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube, or Peritoneal Carcinoma
調査の概要
詳細な説明
This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study comparing safety and efficacy of two dose levels of TXA127 when administered during 6 cycles of combination gemcitabine and platinum-based chemotherapy. This study intends to investigate the effectiveness of TXA127 for the mitigation of severity and/or incidence of thrombocytopenia, as well as safety when administered as a self-injected, subcutaneous solution.
Females 18 years of age or older with a confirmed diagnosis of ovarian carcinoma who are scheduled to undergo combination chemotherapy with gemcitabine and carboplatin or gemcitabine and cisplatin will be considered for this study. Subjects may be chemotherapy naïve, newly diagnosed, or post a single course of chemotherapy followed by a progression- and treatment-free interval of at least 3 months, or post 2 or more previous courses of chemotherapy after a progression- and treatment-free interval of at least 6 months.
Subjects will be randomized in a 1:1:1 ratio to one of the following three blinded treatment groups: placebo, 100 ug/kg/day TXA127 and 300 ug/kg/day TXA127.
Treatment will be concurrent with up to six consecutive 21-day cycles of one of the following gemcitabine and platin regimens:
Regimen A
- Intravenous cisplatin therapy at a dose of 30-50 mg/m2 given on Day 1 of the cycle
- Intravenous gemcitabine at a dose of 800 mg/m2 given on Day 1 after cisplatin and on Day 8 of the cycle.
Regimen B
- Intravenous gemcitabine at a dose of 1000 mg/m2 given on Days 1 and 8 of the cycle
- Intravenous carboplatin AUC 4 given after gemcitabine on Day 1 of the cycle
TXA127 will be self-administered as a subcutaneous injection by the subject once daily on Days 2-6 and 9-15 during each cycle of chemotherapy. Blood specimens will be drawn for hematologic analysis on Days 1, 8 and 15 of each treatment cycle.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Alabama
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Mobile、Alabama、アメリカ、36604
- University of Southern Alabama Mitchell Cancer Institute
-
-
California
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Los Angeles、California、アメリカ、90033
- USC - LAC Medical Center
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Orange、California、アメリカ、92868
- University of California - Irvine, Chao Family Comprehensive Cancer Center
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Illinois
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Chicago、Illinois、アメリカ、60612
- Rush University Medical Center
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Kansas
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Wichita、Kansas、アメリカ、67208
- Associates in Women's Health
-
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New York
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Brightwaters、New York、アメリカ、11718
- Schwartz Gynecologic Oncology, PLLC
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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:
Females at least 18 years of age with ovarian carcinoma who are one of the following:
- Newly diagnosed with ovarian cancer and chemotherapy naïve, or
- Post a single previous course of chemotherapy, with a 3-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit, or
- Post two or more previous courses of chemotherapy with a 6-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit.
- Must be scheduled for a course of combination chemotherapy consisting of gemcitabine and cisplatin or gemcitabine and carboplatin to be administered in 21-day cycles
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Adequate bone marrow, renal, and hepatic functions as measured by standard chemistry and hematology blood tests
- Adequate blood coagulation parameters as measured by standard blood tests for coagulation
Exclusion Criteria:
- Any clinical or laboratory abnormality greater than Grade 2 toxicity (NCI criteria), with the exception of laboratory parameters specified in the inclusion criteria
- Significant unstable cardiovascular disease
- Uncontrolled high blood pressure
- Current use of an angiotensin converting enzyme (ACE) inhibitor or angiotensin II antagonists
- Evidence of metastatic disease to the bone
- Metastatic disease to the CNS requiring treatment or radiation therapy
- Uncontrolled infection(s)
- Radiation therapy or chemotherapy (except as specified in the inclusion criteria) within the previous 5 years
- Concurrent use of hematopoietic or erythropoietic agents
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:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
プラセボコンパレーター:Placebo
Combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
Once daily subcutaneous injection of placebo
|
実験的:TXA127 100 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
Once daily subcutaneous injection of 100 ug/kg
他の名前:
Once daily subcutaneous injection of 300 ug/kg
他の名前:
|
実験的:TXA127 300 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
Once daily subcutaneous injection of 100 ug/kg
他の名前:
Once daily subcutaneous injection of 300 ug/kg
他の名前:
|
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 |
メジャーの説明 |
時間枠 |
---|---|---|
Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
時間枠:During a maximum of six 3-week chemotherapy cycles
|
Mean percentage of cycles with platelet counts below 50,000/mm3
|
During a maximum of six 3-week chemotherapy cycles
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Subjects With Platelet Counts Below 50,000/mm3
時間枠:During a maximum of six 3-week chemotherapy cycles
|
Number of subjects who experienced a platelet count below 50,000/mm3
|
During a maximum of six 3-week chemotherapy cycles
|
Treatment Cycles With Platelets Counts Below 25,000/mm3
時間枠:During a maximum of six 3-week chemotherapy cycles
|
Mean percentage of treatment cycles where platelets counts were below 25,000/mm3
|
During a maximum of six 3-week chemotherapy cycles
|
Chemotherapy Dose Intensity and Dose Density
時間枠:During a maximum of six 3-week chemotherapy cycles
|
Mean percentage of cycles where projected (target) chemotherapy dose was maintained
|
During a maximum of six 3-week chemotherapy cycles
|
Lymphopenia as Determined by Lymphocyte Count
時間枠:During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of lymphopenia
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During a maximum of six 3-week chemotherapy cycles
|
Neutropenia
時間枠:During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of neutropenia
|
During a maximum of six 3-week chemotherapy cycles
|
Anemia
時間枠:During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of anemia
|
During a maximum of six 3-week chemotherapy cycles
|
Mucositis
時間枠:During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of mucositis
|
During a maximum of six 3-week chemotherapy cycles
|
Alopecia
時間枠:During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of alopecia
|
During a maximum of six 3-week chemotherapy cycles
|
Rescue Treatment for Hematopoiesis and Mucositis
時間枠:During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:
|
During a maximum of six 3-week chemotherapy cycles
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Rodgers KE, Oliver J, diZerega GS. Phase I/II dose escalation study of angiotensin 1-7 [A(1-7)] administered before and after chemotherapy in patients with newly diagnosed breast cancer. Cancer Chemother Pharmacol. 2006 May;57(5):559-68. doi: 10.1007/s00280-005-0078-4. Epub 2005 Aug 12.
- Ellefson DD, diZerega GS, Espinoza T, Roda N, Maldonado S, Rodgers KE. Synergistic effects of co-administration of angiotensin 1-7 and Neupogen on hematopoietic recovery in mice. Cancer Chemother Pharmacol. 2004 Jan;53(1):15-24. doi: 10.1007/s00280-003-0710-0. Epub 2003 Oct 16.
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 (実際)
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
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。
Placeboの臨床試験
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Palacky University完了
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Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
-
Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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University Hospital, Strasbourg, France積極的、募集していない