Metastatic Pancreatic CancerPhase 2OECTAPGAMPCNCT02863367
A One-Arm Exploratory Clinical Trial of Apatinib Plus Gemcitabine in Patients With Advanced Metastatic Pancreatic Cancer
A Phase 2 study testing Apatinib and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
Evaluate the efficacy and safety of Apatinib (500mg/d) with gemcitabine(1000mg/m2) in advanced metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Apatinib and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of patients ranges from 18 to 75 years old.
- Histologically or cytologic confirmed advanced metastatic pancreatic cancer (Exclusion of islet cell tumor ) .
- Must not received radiotherapy, chemotherapy or experimental treatment for advanced metastatic pancreatic cancer. Transfer of postoperative recurrence of patients with advanced pancreatic cancer can also be into the group.
- Karnofsky Performance Status Scale (KPS) ≥70.
- The first confirmed date of advanced metastatic pancreatic cancer not more than 6 weeks before starting treatment.
- No jaundice symptoms. Obviously abdominal water or have symptoms, need a drainage in advance. Don't need to adjust the analgesic therapy.
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- Adequate hematologic functions :Hemoglobin (HGB) ≥ 90g/dL, Platelets (PLT) ≥ 100×10^9/L, the absolute number of Neutrophil (ANC) ≥ 1.5×10^9/L.
- Adequate hepatic, renal, heart functions :Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×the upper limit of normal (ULN).If liver metastases, AST and ALT ≤5.0×the ULN. Total bilirubin within the ULN. Serum Creatinine within the ULN, or creatinine clearance ≥ 60 mL/min.
- Blood coagulation test results: Prothrombin Time (PT) and Partial Thromboplastin Time (PPT) within ±15% of the normal.
- No clinically significant abnormal urine analysis results.
- Women with pregnancy or lactation, or fertility but during treatment and 6 months after treatment of termination unwilling or unable to use effective contraception to avoid pregnancy patients with male or female
- Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- Patient consent and well compliance, scheduled to accept the visits, treatment, laboratory tests and other study procedures
Who cannot join
- Patients with the known brain metastases.
- Patients with locally advanced disease only.
- Decline in serum albumin (ALB) ≥ 20% from the screening visit to cycle 1 day 1 prior to the 72 hours.
- Over the past five years has a history of malignant tumors (including chronic leukemia). Patients with carcinoma in situ or basal cell carcinoma or squamous cell skin cancer can be selected.
- With need of systemic treatment activity, unable to control bacterial, viral or fungal infections
- Known HIV infection, or active hepatitis B or hepatitis C virus (HCV) infection.
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- A major surgery (not include the diagnostic surgery) not more than 4 weeks before starting treatment.
- In the period of 6 months before starting treatment, Patients with myocardial infarction, severe or unstable angina, coronary artery and peripheral artery bypass grafting, New York heart association (NYHA) three - four level cardiac failure, out of control of high blood pressure, Patients with clinical significance of arrhythmia or abnormal electrocardiogram (ECG), cerebrovascular accident, transient ischemic attack, epilepsy, or with clinical significance of arrhythmia or a history of abnormal electrocardiogram (ECG).
- Has any study drug or its accessories history of allergies or allergic reactions, or patients showed this product or controlled drug prescribing information "contraindications or special warnings and precautions" section Outlines of events.
- The history of connective tissue disease (such as lupus, scleroderma, nodular arteritis).
- Has a history of interstitial pneumonia, slowly progressive dyspnea and cough, sarcoidosis, and silicosis, idiopathic pulmonary fibrosis, hypersensitivity pneumonitis, or a variety of allergies.
- Could damage patient safety or the integrity of the data to any situation, including severe medical risk factors, medical events and laboratory abnormalities or mental illness;
- Enter any other clinical study, some involved in drug test, or may interfere with the study in the program evaluation;
- The patient is not willing to or cannot meet research program, or plans for vacation during the research and treatment more than 7 days or seven days;
- The investigator think that the person doesn't fit into the study.
Trial locations and contacts
No sites are listed yet.
About this study
Evaluate the efficacy and safety of Apatinib (500mg/d) with gemcitabine(1000mg/m2) in advanced metastatic pancreatic cancer.
Read the detailed description
This test is a single center, one-armed exploratory clinical research, aimed at the evaluation the efficacy and safety of Apatinib with Gemcitabine in the patients with advanced metastatic pancreatic cancer.
This study plan in Tianjin Medical University Cancer Institute and Hospital.From launched in July 2016, this research intends to recruit the end time about as of December 2017, is expected to the end of the test time is in December 2017.
If do not have the appearance of the following circumstances, such as the subjects out of informed consent, drug toxicity tolerance or the researchers think that do not fit for further test, each subject research and treatment time is expected until imaging of tumor progression.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Apatinib, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called YN968D1
Apatinib：500 mg，po，qd, d1-14, every 3 week
GemcitabineDrug
Gemcitabine：1000mg/m²，vein input 30-40，d1，d8，every 3 week
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Apatinib：500 mg，po，qd, d1-14, every 3 week Gemcitabine：1000mg/m²，vein input 30-40，d1，d8，every 3 week Receives: Drug: Apatinib; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: 1 years
Secondary outcomes (5)
progression-free survival (PFS)
Measured: 1 years
Overall Survival (OS)
Measured: 1 years
Life Quality Score (QoL)
Measured: 1 years
Disease Control Rate (DCR)
Measured: 1 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Ji Hui, PhD, Principal investigator, National Clinical Research Center for Cancer of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863367
- Sponsor's protocol ID
- AHEAD-HBP001
- Acronym
- OECTAPGAMPC
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One-Arm Exploratory Clinical Trial of Apatinib Plus Gemcitabine in Patients With Advanced Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02863367
- Acronym / sponsor ID
- OECTAPGAMPC / AHEAD-HBP001
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety of Apatinib (500mg/d) with gemcitabine(1000mg/m2) in advanced metastatic pancreatic cancer.
Detailed description
This test is a single center, one-armed exploratory clinical research, aimed at the evaluation the efficacy and safety of Apatinib with Gemcitabine in the patients with advanced metastatic pancreatic cancer.
This study plan in Tianjin Medical University Cancer Institute and Hospital.From launched in July 2016, this research intends to recruit the end time about as of December 2017, is expected to the end of the test time is in December 2017.
If do not have the appearance of the following circumstances, such as the subjects out of informed consent, drug toxicity tolerance or the researchers think that do not fit for further test, each subject research and treatment time is expected until imaging of tumor progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Apatinib, Drug: GemcitabineApatinib：500 mg，po，qd, d1-14, every 3 week Gemcitabine：1000mg/m²，vein input 30-40，d1，d8，every 3 week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age of patients ranges from 18 to 75 years old.
- Histologically or cytologic confirmed advanced metastatic pancreatic cancer (Exclusion of islet cell tumor ) .
- Must not received radiotherapy, chemotherapy or experimental treatment for advanced metastatic pancreatic cancer. Transfer of postoperative recurrence of patients with advanced pancreatic cancer can also be into the group.
- Karnofsky Performance Status Scale (KPS) ≥70.
- The first confirmed date of advanced metastatic pancreatic cancer not more than 6 weeks before starting treatment.
Key exclusion criteria (15 listed)
- Patients with the known brain metastases.
- Patients with locally advanced disease only.
- Decline in serum albumin (ALB) ≥ 20% from the screening visit to cycle 1 day 1 prior to the 72 hours.
- Over the past five years has a history of malignant tumors (including chronic leukemia). Patients with carcinoma in situ or basal cell carcinoma or squamous cell skin cancer can be selected.
- With need of systemic treatment activity, unable to control bacterial, viral or fungal infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApatinibAlso: YN968D1Apatinib：500 mg，po，qd, d1-14, every 3 week | Drug | Treatment group |
| GemcitabineGemcitabine：1000mg/m²，vein input 30-40，d1，d8，every 3 week | Drug | Treatment group |
Primary outcome
Objective Response Rate (ORR)
Time frame: 1 years
5 secondary outcomes
progression-free survival (PFS)
Time frame: 1 years
Overall Survival (OS)
Time frame: 1 years
Life Quality Score (QoL)
Time frame: 1 years
Disease Control Rate (DCR)
Time frame: 1 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Ji Hui, PhD principal investigator
National Clinical Research Center for Cancer of China
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Ji Hui, PhD (022-23340123 ext. 3070, renhe@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.