Study Of CG200745 PPA In Combination With Gemcitabine And Erlotinib For Advanced Pancreatic Cancer

Study Overview

Study of CG200745 PPA in Combination With Gemcitabine and Erlotinib for Advanced Pancreatic Cancer

The phase I clinical trial is to identify the MTD (Maximum Tolerated Dose) and DLT (Dose Limiting Toxicity) of CG200745 PPA in combination use of Gemcitabine and Erlotinib. Initial dose of CG200745 PPA is 187.5 mg/m^2, and it will be extended to 250 mg/m^2, 312.5 mg/m^2 or it will be reduced to 125 mg/m^2 based on the results of the cohort of 3 subjects per dose level. Based on the 3+3 dose escalation study design, Gemcitabine and Erlotinib are administered as fixed doses, whereas CG200745 PPA is to be administered as in four different cohorts according to the dose level. Each cohort consists of 3 or 6 subjects. In the phase II clinical trial, the subjects will be administered with the dose which is to be identified as a recommended dose based on the results of Phase I study. The whole one cycle is consisted of 28 days, same as the phase I. The entire treatment period is 6 cycles and tumor assessment is evaluated every 2 cycles.

The phase I clinical trial is to identify the MTD and DLT of CG200745 PPA in combination use of Gemcitabine and Erlotinib. Initial dose of CG200745 PPA is 187.5 mg/m^2, and it will be extended to 250 mg/m^2, 312.5 mg/m^2 or it will be reduced to 125 mg/m^2 based on the results of the cohort of 3 subjects per dose level. Based on the 3+3 dose escalation study design, Gemcitabine and Erlotinib are administered as fixed doses, whereas CG200745 PPA is to be administered as in four different cohorts according to the dose level. Each cohort consists of 3 or 6 subjects. * Dose level 0: CG200745 PPA 125 mg/m^2 puls Gemcitabine 1000 mg/m^2) and Erlotinib 100 mg * Dose level 1: CG200745 PPA 187.5 mg/m^2 puls Gemcitabine 1000 mg/m^2) and Erlotinib 100 mg * Dose level 2: CG200745 PPA 250 mg/m^2 puls Gemcitabine 1000 mg/m^2) and Erlotinib 100 mg * Dose level 3: CG200745 PPA 312.5 mg/m^2 puls Gemcitabine 1000 mg/m^2) and Erlotinib 100 mg In the phase II clinical trial, the subjects will be administered with the dose which is to be identified as a recommended dose based on the results of Phase I study. The whole one cycle is consisted of 28 days, same as the phase I. The entire treatment period is 6 cycles and tumor assessment is evaluated every 2 cycles.

Pancreatic Neoplasms

DRUG: CG200745 PPA
DRUG: Gemcitabine
DRUG: Erlotinib

CG200745-2-03

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-03-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-06-13
First Submitted that Met QC Criteria 2016-04-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-06-17
First Posted (ACTUAL) 2016-04-13	Results First Posted N/A	Last Verified 2019-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CG200745 PPA CG200745 PPA plus Gemcitabine and Erlotinib	DRUG: CG200745 PPA CG200745 PPA IV every week three times per cycle (4 weeks) DRUG: Gemcitabine 1000 mg/m^2 intravenously every week three times per cycle (4 weeks) DRUG: Erlotinib 100 mg per oral daily per cycle (4 weeks)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CG200745 PPA

CG200745 PPA plus Gemcitabine and Erlotinib

DRUG: CG200745 PPA

CG200745 PPA IV every week three times per cycle (4 weeks)

DRUG: Gemcitabine

1000 mg/m^2 intravenously every week three times per cycle (4 weeks)

DRUG: Erlotinib

100 mg per oral daily per cycle (4 weeks)

Primary Outcome Measures	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR is the proportion of the subjects with CR and PR in comparison to the total subjects at the final tumor assessment point (cycle 6) from the baseline	up to 6 cycles (each cycle is 28 days)

Secondary Outcome Measures	Measure Description	Time Frame
Disease control rate (DCR)	DCR is the proportion of the subjects with Complete Response (CR), Partial Response (PR), and stable disease (SD) in comparison to the total subjects at the final tumor assessment point (cycle 6) from the baseline	up to 6 cycles (each cycle is 28 days)
Area Under the Curve [AUC]	Pharmacokinetics (PK) parameter	before the administration and up to 1440 mins after completion of the IP (Investigational Product) administration
Maximum Plasma Concentration [Cmax]	Pharmacokinetics (PK) parameter	before the administration and up to 1440 mins after completion of the IP administration
Adverse Events	safety parameter	up to 6 cycles (each cycle is 28 days)
Clinical laboratory tests	safety parameter	up to 6 cycles (each cycle is 28 days)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

Ages: ≥ 20 and ≤ 75 years
Subjects who join voluntarily for participation in the study, sign the consent form and are willing to comply the clinical trial procedure
Subjects who have diagnosed with unresectable, locally advanced, metastatic, histologically and cytologically confirmed pancreatic adenocarcinoma
ECOG (Eastern Cooperative Oncology Group) performance status: 0-2
Estimated life expectancy at the time of enrollment is more than 3 months
Adequate hematological, renal and hepatic function

Absolute neutrophil count (ANC) ≥ 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 creatinine clearance rate (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.

Serum bilirubin < 2 x Upper Limit Normal (ULN), Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) < 2.5 x ULN, Alkaline phosphatase (ALP) < 5 x ULN (If liver metastasis, AST/ALT <5 x ULN)
Prothrombin Time (PT) or Partial thromboplastin time (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)
No prior chemotherapy, radiation or biologics

Subject who had experienced a major surgery within 2 weeks prior to the screening visit
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)
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.
Subjects who have treated antibiotics within last seven days due to an active bacterial infection prior to the enrollment. (Topical antibiotic therapies are excluded)
Subjects who had experienced any malignancies within past 5 years, except for basal cell skin cancer, in situ cervical cancer, or papillary thyroid tumor.
Pregnancy or Lactating
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 salpingectomy, 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
Subject who cannot take anti-cancer chemotherapy due to a systemic disease (ex. chronic renal failure)
Subjects who have treated with any other investigational drug within 4 weeks prior to the screening visit
History of hypersensitivity to study drug
Subject with HIV positive

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Siyoung Song, M.D., PhD., Yonsei University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record