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Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03579836
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
BeyondBio Inc.

Brief Summary:
This study is a single center, open-label, non-comparative, phase I/II clinical trial to assess the maximum tolerated dose (MTD), safety and efficacy of BEY1107 in monotherapy and in combination with gemcitabine in patient With locally advanced or metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Pancreatic Cancer Drug: BEY1107 Combination Product: Gemcitabine Phase 1 Phase 2

Detailed Description:

The key purpose of the main part of the study is to assess the MTD, safety and efficacy of BEY1107 as monotherapy and combination therapy for locally advanced and/or metastatic pancreatic cancer. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of BEY1107, to determine the MTD.

Patient will receive BEY1107 for 4 weeks in monotherapy for each cohort (administered in a 3-weeks-on / 1-week-off) during Phase I-1 trial.

At next stage, patient will receive BEY1107 with gemcitabine for 4weeks in phase I-2 trial.

Final stage, patient will receive BEY1107 with gemcitabine for 24weeks in phase II trial.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival of fresh biopsy tissue will also be collected for biomarker analysis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Open-label, Non-comparative, Phase I/II Clinical Trial to Assess the MTD, Safety and Efficacy of BEY1107 in Monotherapy and in Combination With Gemcitabine in Patient With Locally Advanced or Metastatic Pancreatic Cancer
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase I-1 (#4 Cohort)
BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
Drug: BEY1107
Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.

Experimental: Phase I-2 (#3 Cohort)
BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)
Drug: BEY1107
Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.

Combination Product: Gemcitabine
Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.

Experimental: Phase II (#1 Cohort)
BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)
Drug: BEY1107
Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.

Combination Product: Gemcitabine
Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.




Primary Outcome Measures :
  1. MTD & Safety assessment (Phase I) [ Time Frame: 0 ]
  2. DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II) [ Time Frame: 0 ]

Secondary Outcome Measures :
  1. AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I) [ Time Frame: 0 ]
  2. Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I) [ Time Frame: 0 ]
  3. DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I) [ Time Frame: 0 ]
  4. ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II) [ Time Frame: 0 ]
  5. Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II) [ Time Frame: 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  1. Histologically or Cytologically confirmed with pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
  2. At lease one measurable lesion according to RECIST v.1.1
  3. Eastern Cooperative Oncology Group (ECOG) 0,1 or 2
  4. Over 12 weeks of Life expectancy
  5. Adequate Bone marrow, Renal and Liver function at screening

Exclusion criteria :

  1. A patient who has treatment history with locally advanced and/or metastatic pancreatic cancer
  2. Major surgery history at screening
  3. Uncontrolled brain metastasis evidence
  4. Active bacterial infection patients
  5. Malignant tumor other than basal cell carcinoma, cervix carcinoma in situ and papillary thyroid cancer
  6. expected Pregnant or breast-feeding patients
  7. HIV, Active hepatitis B or C infection
  8. A patient who has hypersensitivity with BEY1107 or Gemcitabine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579836


Contacts
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Contact: BeyondBio Inc. +82-42-716-0020 clinicaltrials@beyondbio.co.kr

Locations
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Korea, Republic of
Yonsei University Health System Severance Hospital Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
BeyondBio Inc.

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Responsible Party: BeyondBio Inc.
ClinicalTrials.gov Identifier: NCT03579836     History of Changes
Other Study ID Numbers: BEY-2018-01
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeyondBio Inc.:
Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs