Phase 2 Study of S-1 as 2nd Line Therapy in Metastatic Pancreatic Cancer
An Open-Label, Non-Randomized, Multicenter, Two-Stage, Phase 2 Study of S-1 as 2nd Line Therapy for Patients With Metastatic Pancreatic Cancer Who Have Previously Received 1st Line Treatment With a Gemcitabine Regimen
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ2
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:
1. Has provided written informed consent. 2. Has histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
3. Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (ie, lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral computed tomography [CT] scan).
4. Is able to take medications orally. 5. Is 18 years of age or older. 6. Has a Karnofsky Performance Status (KPS) ≥ 70% (see Appendix A). 7. Has a life expectancy of ≥ 12 weeks. 8. Has adequate organ function as defined by the following criteria:
- Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times the upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be ≤ 5 times ULN.
- Total serum bilirubin ≤ 3.0 times ULN (if due to underlying liver metastasis, then total bilirubin may be ≤ 5 times ULN).
- Absolute granulocyte count ≥ 1,500/mm3 (ie, ≥ 1.5 x 109/L by International Units [IU]).
- Platelet count ≥ 100,000/mm3 (IU: ≥ 100 x 109/L).
- Hemoglobin value ≥ 9.0 g/dL.
Calculated creatinine clearance ≥ 60 mL/min (based on serum creatinine) (Cockcroft-Gault85 formula) 9. Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
1. Has had treatment with any of the following within the specified time frame prior to study drug administration:
- Any prior anticancer chemotherapy.
- Radiation therapy to a target lesion unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease).
- Any radiotherapy within the previous 3 weeks.
- Any investigational agent received either concurrently or within the last 30 days.
Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study.
2. Major surgery within the previous 3 weeks. 3. Symptomatic brain metastasis not controlled by corticosteroids. 4. Leptomeningeal metastasis. 5. Previous or concurrent malignancy other than pancreatic cancer except adequately treated carcinoma in-situ of the cervix or non-melanoma skin cancer. 6. Uncontrolled ascites requiring drainage at least twice a week. 7. Other serious illness or medical condition(s) including, but not limited to, the following:
- Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class III or IV), angina pectoris, arrhythmias, or hypertension.
- Active infection.
- Known (at time of entry) gastrointestinal disorder, including malabsorption, chronic nausea, vomiting, or diarrhea, present to the extent that it might interfere with oral intake and absorption of study medication.
- Poorly controlled diabetes mellitus.
- Psychiatric disorder that may interfere with consent and/or protocol compliance.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
8. Is receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:
- Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1 activity).
- Allopurinol (may diminish S-1 activity).
- Phenytoin (S-1 may enhance phenytoin activity).
Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 and flucytosine activity).
9. Is a pregnant or lactating female. 10. Has known sensitivity to 5-FU. 11. Is a patient with reproductive potential who refuses to use an adequate means of contraception (including male patients).
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:なし
- 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
All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks.
|
All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks.
The trial will proceed to the second stage only if sufficient efficacy is demonstrated in Stage 1.
|
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 |
---|---|
Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR)
時間枠:Each cycle will last 21 days (14 days treatment, 7 days recovery) for 6 mos. Tumor assessmentswill be obtained at baseline) and at the end of every even cycle.
|
Each cycle will last 21 days (14 days treatment, 7 days recovery) for 6 mos. Tumor assessmentswill be obtained at baseline) and at the end of every even cycle.
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
To evaluate the duration of response (DR), progress-free survival (PFS), and survival rate
時間枠:Each cycle will last 21 days (14 days treatment, 7 days recovery for 6 mos. Pts will be followed for survival status every 2 months following PD for up to 6 mos.
|
Each cycle will last 21 days (14 days treatment, 7 days recovery for 6 mos. Pts will be followed for survival status every 2 months following PD for up to 6 mos.
|
To investigate the effect of S-1 on Karnofsky Performance Status (KPS), weight, and analgesic consumption
時間枠:KPS and wt measured at baseline; w/in 24 hrs pr study drug on Day 1 of each cycle after Cycle 1; end of study treatment. Info on analgesics gathered at least 7 days prior to Day 1 of Cycle 1 and continuing through end of treatment.
|
KPS and wt measured at baseline; w/in 24 hrs pr study drug on Day 1 of each cycle after Cycle 1; end of study treatment. Info on analgesics gathered at least 7 days prior to Day 1 of Cycle 1 and continuing through end of treatment.
|
To evaluate CA19-9 decline
時間枠:Each cycle will last 21 days (14 days treatment, 7 days recovery) for 6 mos. CA19-9 levels will be collected at basleine, Day 1 of each cycle, and at the end of treatment.
|
Each cycle will last 21 days (14 days treatment, 7 days recovery) for 6 mos. CA19-9 levels will be collected at basleine, Day 1 of each cycle, and at the end of treatment.
|
To evaluate the safety profile of S-1
時間枠:AEs will be reported from the time a patient signs informed consent through the period of patient follow-up Blood/urine will be collected at baseline; Days 8&15; w/in 24 hrs of study drug on Day 1 of each cycle after Cycle 1; at end of study treatment.
|
AEs will be reported from the time a patient signs informed consent through the period of patient follow-up Blood/urine will be collected at baseline; Days 8&15; w/in 24 hrs of study drug on Day 1 of each cycle after Cycle 1; at end of study treatment.
|
To investigate the relationship of S-1 plasma levels (components and metabolites) with safety and efficacy parameters
時間枠:Each cycle will last 21 days (14 days treatment, 7 days recovery) for 6 mos. Blood samples to be obtained 1.5 ± 0.5 h, 5 ± 1 h, 7 ± 1 h postdose on Day 1 of Cycle 1 only.
|
Each cycle will last 21 days (14 days treatment, 7 days recovery) for 6 mos. Blood samples to be obtained 1.5 ± 0.5 h, 5 ± 1 h, 7 ± 1 h postdose on Day 1 of Cycle 1 only.
|
協力者と研究者
スポンサー
協力者
捜査官
- スタディディレクター:Fabio Benedetti, MD、Taiho Oncology, Inc.
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
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。
S-1の臨床試験
-
Fudan UniversityThe First Affiliated Hospital of Anhui Medical University; Guangdong Provincial Hospital of... と他の協力者引きこもった
-
Peking University Cancer Hospital & Institute募集
-
Taiho Oncology, Inc.Quintiles, Inc.; United BioSource, LLC完了局所進行性または転移性膵臓がん
-
TTY BiopharmNational Taiwan University Hospital; Chang Gung Memorial Hospital; Taipei Veterans General Hospital... と他の協力者終了しました