A Retrospective-Prospective Study of the Efficacy and Safety of Apatinib Monotherapy as First-Line Treatment in Elderly Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer



Sponsors


Source

First Affiliated Hospital Bengbu Medical College

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

The study is to investigate the efficacy and safety of apatinib for the first-fine treatment
in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or
gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free
survival (PFS). Apatinib will be given to patients with an efficacy assessment of stable
disease (SD), partial response (PR), or complete response (CR) every 2 cycles. Patients were
assigned to 500 mg/d apatinib continually until disease progression or intolerable toxicity
or patients withdrawal of consent. The dose of apatinib may be decreased to 250 mg/d
following the occurrence of a clinically significant adverse event (AE). Treatment will be
discontinued if the subject is unable to tolerate a daily dose of 250 mg, and the sample size
is about 30 individuals. Tumor tissue samples will be collected from each enrolled subjects
before the start of treatment, and detected using next generation sequencing (NGS)-based
comprehensive genomic profiling. The potential biomarkers in predicting apatinib efficacy or
safety will be explored.

Overall Status

Recruiting

Start Date

2017-08-01

Completion Date

2020-02-01

Primary Completion Date

2019-08-01

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Progression-free survival (PFS)
1 year

Secondary Outcome

Measure

Time Frame

Overall survival (OS)
2 years
Disease control rate (DCR)
1 year
Objective response rate (ORR)
1 year
Quality of life score (QoL)
1 year
Adverse Events(AEs)
1 year

Enrollment

30

Conditions


Intervention

Intervention Type

Drug

Intervention Name


Description

Apatinib is taken 500 mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death. The dose of the study drug may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg.

Arm Group Label

Apatinib Group


Eligibility

Criteria

Inclusion Criteria:

1. Patients with histologically proven primary locally advanced or metastatic gastric or
gastroesophageal junction adenocarcinoma;

2. Age ≥ 65 years;

3. ECOG Performance Status: 0-2;

4. No previous anti-cancer therapy for the locally advanced or metastatic disease;

5. Unable or unwilling to chemotherapy;

6. At least one measurable lesion as defined by RECIST 1.1;

7. With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;

8. Can take apatinib orally;

9. Life Expectancy: 3 months or more.

Exclusion Criteria:

1. History of other primary malignancy (except basal cell skin cancer or cervical
carcinoma in situ);

2. Patients with un-controlled blood pressure on medication (> 140/90 mmHg);

3. Patients with other nonmeasurable disease such as un-controlled diabetes, severe
cardiovascular and cerebrovascular diseases;

4. Patients with bleeding tendency, receiving thrombolytics or anticoagulants;

5. Patients with massive hydrothorax or ascites;

6. Patients with uncontrolled central nervous system (CNS) metastases;

7. Proteinuria 2+ or 24-hour urinary protein ≥ 1g;

8. History of drug addiction or abuse;

9. Patients cannot take apatinib orally for any reason;

10. Estimated life expectancy ˂ 3 months;

11. Current, recent (within 4 weeks prior to study entry), or planned participation in any
other clinical trials;

12. Inability to understand and agree to informed consent.

Gender

All

Minimum Age

65 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Qiong Wu, M.D.,Ph.D
Principal Investigator
First Affiliated Hospital of Bengbu Medical College

Overall Contact

Last Name

Yan Yang, M.D.,Ph.D

Phone

+86-552-3086178

Email

[email protected]


Location

Facility

Status

Contact

Investigator

Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
Bengbu Anhui 233004 China
Recruiting
Last Name: Yan Yang, M.D., Ph.D.
Phone: +86-552-3086178
Email: [email protected]
Last Name: Qiong Wu, M.D., Ph.D.
Role: Principal Investigator

Location Countries

Country

China


Verification Date

2017-07-01

Lastchanged Date

2017-07-13

Firstreceived Date

2017-07-13

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

First Affiliated Hospital Bengbu Medical College

Investigator Full Name

Qiong Wu

Investigator Title

Principal Investigator


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Arm Group

Arm Group Label

Apatinib Group

Arm Group Type

Experimental

Description

take apatinib orally (500mg/d, once a day, continuously)


Firstreceived Results Date

N/A

Other Outcome

Measure

Tumor biomarkers

Time Frame

Before the start of apatinib treatment

Description

Tumor tissue samples will be applied to next generation sequencing (NGS) detection to reveal any gene variation through comprehensive genomic profiling.


Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Intervention Model Description

Apatinib Monotherapy

Primary Purpose

Treatment

Masking

No masking



ClinicalTrials.gov processed this data on July 17, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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