- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04643405
APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
An Open Label, Multiple Centers Phase Ib/II Study of APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The ability of tumor cells to evade apoptosis is currently a major problem in anti-tumor therapy. IAPs are an important class of apoptosis-regulating proteins. APG-1387, a potent bivalent SMAC mimetic, small molecule of IAP inhibitor, which could inhibit pancreatic cancer proliferation as monotherapy and in combination with chemotherapy through apoptosis pathway.
It's an open label, multiple centers phase Ib/II Study. Safety and tolerability of APG1387 combined with nab-paclitaxel and gemcitabine will be evaluated in phase Ib in previously-treated, advanced pancreatic adenocarcinoma patients. Efficacy and tolerability will be evaluated in phase II study in first line standard treatment failed metastatic pancreatic adenocarcinoma patients.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Xianjun Yu, MD
- Phone Number: +86-21-64175590
- Email: yuxianjun@fudanpci.org
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Si Shi, PhD
- Phone Number: +86-21-64175590
- Email: shisi@fudanpci.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects must be ≥18 years of age at time of informed consent
- Able to comply with the study protocol, in the investigator's judgment
- Expected survival ≥ 3 months
Histology or cytology confirmed as advanced pancreatic adenocarcinoma, and:
- Standard treatment failed or intolerant to standard treatment(Phase Ib);
- First line standard treatment failed (Phase II).
- ECOG 0-1;
- Adequate organ function.
- Subjects must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment
Exclusion Criteria:
- Has had chemotherapy, radiation, target or other antitumor therapy within 14 days prior to the first dose of study drug.
- Has received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
- Has received a therapy with TNFα within 28 days of the first dose of study drug.
- Known active central nervous system involvement.
- Has received IAP-inhibitor before.
- Has had major surgery within 28 days of dosing of investigational agent, or minor surgery within 14 days.
- Patients with clinically evident Hepatitis B surface antigen (HBs) positive, Hepatitis C virus (HCV) antibody positive, Human Immunodeficiency Virus (HIV) antibody positive.
- Pregnant or breastfeeding (lactating) women.
- Other situations that investigator think not suit for study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: APG1387 in combination with Gemcitabine and Nab-Paclitaxel
|
APG1387 will be administered IV days 1, 8, 15 and 22 of a 28 day cycle.
Gemcitabine 1000 mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.
Nab-Paclitaxel 125mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Limiting Toxicities (DLT) of combination therapy (Applicable for: phase Ib stage ).
Time Frame: 28 days.
|
DLT will be graded according to NCI CTCAE Version 5.0.
DLT will be defined as clinically significant drug-related adverse events during the cycle one.
|
28 days.
|
Overall Response Rate (Applicable for: phase II stage) .
Time Frame: Up to 2 years.
|
Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Up to 2 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: Up to 2 years.
|
From date of treatment start until the date of progression or the date of death due to any cause.
|
Up to 2 years.
|
Duration of Response (DOR)
Time Frame: Up to 2 years.
|
From date of response until the date of progression.
|
Up to 2 years.
|
Overall Survival (OS)
Time Frame: Up to 2 years.
|
From date of treatment start until the date of death due to any cause.
|
Up to 2 years.
|
Maximum plasma concentration (Cmax)
Time Frame: 28 days.
|
Cmax of APG-1387 and Nab-Paclitaxel will be assessed in the patients in this study.
|
28 days.
|
Area under the plasma concentration versus time curve (AUC)
Time Frame: 28 days.
|
AUC of APG-1387 and Nab-Paclitaxel will be assessed in the patients in this study.
|
28 days.
|
Adverse events
Time Frame: Up to 2 years.
|
Adverse events (AE) and serious adverse events (SAE) will be graded according to NCI CTCAE Version 5.0.
|
Up to 2 years.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Yifan Zhai, MD, PhD, Jiangsu Ascentage Pharma Co., Ltd.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Adenocarcinoma
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Gemcitabine
Other Study ID Numbers
- APG1387PC101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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