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

Primary Purpose

Pancreatic Neoplasms

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CG200745 PPA

Gemcitabine

Erlotinib

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
  ※ 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 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

Exclusion Criteria:

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

Sites / Locations

Yonsei University Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CG200745 PPA

Arm Description

CG200745 PPA plus Gemcitabine and Erlotinib

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Area Under the Curve [AUC]

Pharmacokinetics (PK) parameter

Maximum Plasma Concentration [Cmax]

Pharmacokinetics (PK) parameter

Adverse Events

safety parameter

Clinical laboratory tests

safety parameter

Full Information

NCT ID

NCT02737228

First Posted

March 22, 2016

Last Updated

June 13, 2019

Sponsor

CrystalGenomics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02737228

Brief Title

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

Official Title

A Phase I/II Study of Combination Therapy of CG200745 PPA With Gemcitabine and Erlotinib to Determine the Maximum Tolerated Dose (MTD) and Evaluate the Safety and Efficacy for Locally Advanced Unresectable, or Metastatic Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

August 2019 (Anticipated)

Study Completion Date

August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CrystalGenomics, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

<Part I - Phase I trial> 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. <Part II - Phase II trial> 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.

Detailed Description

<Part I - Phase I trial> 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 <Part II - Phase II trial> 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CG200745 PPA

Arm Type

Experimental

Arm Description

CG200745 PPA plus Gemcitabine and Erlotinib

Intervention Type

Drug

Intervention Name(s)

CG200745 PPA

Other Intervention Name(s)

CG200745 PPA (phosphoric acid)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

combination therapy 1

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Other Intervention Name(s)

combination therapy 2

Intervention Description

100 mg per oral daily per cycle (4 weeks)

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR)

Description

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

Time Frame

up to 6 cycles (each cycle is 28 days)

Secondary Outcome Measure Information:

Title

Disease control rate (DCR)

Description

Time Frame

up to 6 cycles (each cycle is 28 days)

Title

Area Under the Curve [AUC]

Description

Pharmacokinetics (PK) parameter

Time Frame

before the administration and up to 1440 mins after completion of the IP (Investigational Product) administration

Title

Maximum Plasma Concentration [Cmax]

Description

Pharmacokinetics (PK) parameter

Time Frame

before the administration and up to 1440 mins after completion of the IP administration

Title

Adverse Events

Description

safety parameter

Time Frame

up to 6 cycles (each cycle is 28 days)

Title

Clinical laboratory tests

Description

safety parameter

Time Frame

up to 6 cycles (each cycle is 28 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. ※ 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 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Siyoung Song, M.D., PhD.

Organizational Affiliation

Yonsei University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei University Health System

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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