A Phase I/II Study of Combination Therapy of CG200745 PPA (Histone Deacetylase Inhibitor) with Gemcitabine and Erlotinib to Determine the Maximum Tolerated Dose and Evaluate the Safety and Efficacy for Locally Advanced Unresectable, or Metastatic Pancreatic Cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0002037
- Lead Sponsor
- CrystalGenomics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
1)Ages : = 20 and = 75 years
2)Subjects who join voluntarily for participation in the study, sign the consent form and are willing to comply the clinical trial procedure
3)Subjects who have diagnosed with unresectable, locally advanced, metastatic, histologically and cytologically confirmed pancreatic adenocarcinoma.
4)ECOG (Eastern Cooperative Oncology Group) performance status : 0-2
5)Estimated life expectancy at the time of enrollment is more than 3 months
6)Adequate hematological, renal and hepatic function
•ANC (Absolute neutorphil count) = 1500/mm3, hemoglobin = 9.0 g/dl (eligible if hemoglobin lab values are adjusted with blood transfusion), platelet = 100,000/mm3
•Within normal range of serum creatinine or CCr = 60 ml/min (using Cockcroft-Gault equation )
•Subjects who have no abnormal serum electrolyte values (including calcium, magnesium, phosphorous and potassium). However, the supplementation therapy is allowed for normalization of serum electrolytes.
? Normal reference range for Calcium: 8.3~10.5 mg/dl, Magnesium: 1.58~3.0 mg/dl, Phosphorous: 2.4~4.5 mg/dl, Potassium: 3.3~5.5 mmol/L
•Serum bilirubin < 2 x ULN, AST/ALT < 2.5 x ULN, ALP < 5 x ULN (If liver metastasis, AST/ALT <5 x ULN)
•PT or PTT = 1.5 x ULN (except for the use of anticoagulant, in this case, PT/PTT stabilization for up to 2 weeks should be confirmed)
7)No prior chemotherapy, radiation or biologics
1)Subject who had experienced a major surgery within 2 weeks prior to the screening visit
2)Subject with an evidence for uncontrolled brain metastasis (except for the patients with radiologically and neurologically stable brain metastasis without corticosteroid therapy for at least two weeks)
3)Subject who cannot be administered oral drug, or have difficulty to absorb the study drugs due to a history of major gastrointestinal surgery or pathological findings.
4)Subjects who have treated antibiotics within last seven days due to an active bacterial infection prior to the enrollment. (Topical antibiotic therapies are excluded)
5)Subjects who had experienced any malignancies within past 5 years, except for basal cell skin cancer, in situ cervical cancer, or papillary thyroid tumor.
6)Pregnancy or Lactating
7)Fertile subjects who do not agree with the effective contraception during the study period and up to 3 months after the completion of the study. The following cases are exceptions: an irreversible and surgical sterility by hysterectomy, bilateral oophorectomy or bilateral salpingoectomy, and menopausal women over 50 years old with no menstruation for at least 12 months and without hormonal therapy. Tubal ligation is not regarded as an effective contraception.
8)Subject who cannot take anti-cancer chemotherapy due to a systemic disease (ex. chronic renal failure)
9)Subjects who have treated with any other investigational drug within 4 weeks prior to the screening visit
10) History of hypersensitivity to study drug
11) Subject with HIV positive
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DCR(Disease control rate) is the proportion of the subjects with CR(Complete response), PR(Partial response), and stable disease (SD) in comparison to the total subjects at the final tumor assessment point (cycle 6) from the baseline.
- Secondary Outcome Measures
Name Time Method ORR (Objective response rate)