Lung AdenocarcinomaPhase 1NCT02691871
Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Lung Adenocarcinoma Harboring Wild-type EGFR
A Phase 1 study testing Apatinib (250 mg/d) + Docetaxel (60 mg/m2), Apatinib (500 mg/d) + Docetaxel (60 mg/m2) and Apatinib (750 mg/d) + Docetaxel (60 mg/m2) in people with Lung Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
The purpose of this study is to confirm the safety of Apatinib at a dose level up to 750 mg/d with standard therapy of docetaxel (60 mg/m²) in advanced lung adenocarcinoma patients harboring wild-type EGFR after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- Apatinib (250 mg/d) + Docetaxel (60 mg/m2), Apatinib (500 mg/d) + Docetaxel (60 mg/m2) and Apatinib (750 mg/d) + Docetaxel (60 mg/m2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2016
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years to 65 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1;
- Life expectancy of more than 12 weeks;
- At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy =< 3 months;
- Histologically/cytologically confirmed advanced/metastatic lung adenocarcinoma of stage IV with documented wild-type EGFR;
- Patients with one prior platinum-containing chemotherapy. In case of recurrent disease, one additional prior regimen is allowed for adjuvant and/or neoadjuvant therapy.
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- Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 50 mL/min, INR < 1.5 or PT < ULN+4s or APTT < 1.5×ULN, proteinuria < (++) or urinary protein ≤ 1.0 g/24 hrs;
- For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.
- Signed informed consent.
Who cannot join
- Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment;
- Other malignancy within the past five years other than basal cell skin cancer, or carcinoma in situ of the cervix;
- Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction);
- Major injuries and/or surgery =< 4 weeks prior to registration with incomplete wound healing. Patients who have received radiotherapy (except local palliative radiotherapy), chemotherapy, molecular targeted therapy =< 3 weeks, or nitrosoureas/mitomycin chemotherapy =< 6 weeks prior to registration;
- Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
- Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to NYHA criteria or echocardiography check: LVEF<50%;
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- History of clinically significant haemoptysis =< 2 months (more than half of one tea spoon of fresh blood per day) prior to registration. Coagulation disfunction, hemorrhagic tendency or receiving anticoagulant therapy;
- History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood ≥ (++), and vasculitis) =< 3 months prior to randomization;
- Patients who have active brain metastases or leptomeningeal disease. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 3 weeks prior to randomization, or after surgical resection performed at least 3 weeks prior to randomization. No evidence of Grade greater than or equal to 1 CNS hemorrhage based on pretreatment CT or MRI scan;
- Centrally located tumors of local invasion of major blood vessels, or distinct interstitial lung disease by the chest radiographic findings (CT or MRI);
- Treatment with other investigational drugs or other anti-cancer therapy;
- Previous therapy with other VEGFR inhibitors (other than bevacizumab);
- Previous therapy with docetaxel =< 6 months prior to registration;
- Treatment in another investigational trial =< 4 weeks prior to registration;
- Any contraindications for therapy with docetaxel. History of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80). History of hypersensitivity to apatinib and/or the excipients of the trial drugs;
- Active or chronic hepatitis C and/or B infection, or other active uncontrolled infection;
- History of immunodeficiency disease (including HIV positive), concurrent acquired or congenital immunodeficiency syndrome, or history of organ transplantation;
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =< 6 months prior to registration;
- History of arterial or venous thromboembolic events (e.g. CVA, DVT and pulmonary embolism) =< 12 months prior to randomization;
- Administration of strong/potent cytochrome P450 (CYP)3A4 inhibitors within 7 days, or inducers within 12 days;
- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study;
- History of mental diseases;
- Other conditions regimented at investigators' discretion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I, Open-label, Dose-escalation Study of Apatinib in Combination With Docetaxel as 2nd Line Treatment in Patients With Advanced Lung Adenocarcinoma Harboring Wild-type Epidermal Growth Factor Receptor (EGFR)
The purpose of this study is to confirm the safety of Apatinib at a dose level up to 750 mg/d with standard therapy of docetaxel (60 mg/m²) in advanced lung adenocarcinoma patients harboring wild-type EGFR after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.
- Conditions
- Lung Adenocarcinoma
- Being tested
- Apatinib (250 mg/d) + Docetaxel (60 mg/m2), Apatinib (500 mg/d) + Docetaxel (60 mg/m2), Apatinib (750 mg/d) + Docetaxel (60 mg/m2)
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib (250 mg/d) + Docetaxel (60 mg/m2)Drug
Apatinib (500 mg/d) + Docetaxel (60 mg/m2)Drug
Apatinib (750 mg/d) + Docetaxel (60 mg/m2)Drug
| Study group | Role | What they receive |
|---|---|---|
| Apatinib + Docetaxel | Experimental | Low, medium or high dose of Apatinib (days 3-19, q3w) and Docetaxel (60 mg/m2, day 1, q3w) Receives: Drug: Apatinib (250 mg/d) + Docetaxel (60 mg/m2); Drug: Apatinib (500 mg/d) + Docetaxel (60 mg/m2); Drug: Apatinib (750 mg/d) + Docetaxel (60 mg/m2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of Apatinib in combination with Docetaxel (60 mg/m2)
Measured: During the first treatment course, up to 3 weeks
Number of Participants Experienced Dose Limited Toxicity (DLT) in Combination Therapy of Apatinib and Docetaxel
Measured: During the first treatment course, up to 3 weeks
Secondary outcomes (3)
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 for All Courses
Measured: Between the first administration of Docetaxel and 28 days after last administration of Apatinib, up to 1 year
Objective Response Rate (ORR)
Measured: Every 6 weeks from the first treatment course, up to 1 year
Progression-free Survival (PFS)
Measured: Every 6 weeks from the first treatment course, up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Jie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691871
- Sponsor's protocol ID
- Ahead-L301
- Status last verified
- Feb 2016
- First submitted
- 3 Feb 2016
- Last updated
- 25 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose-escalation Study of Apatinib in Combination With Docetaxel as 2nd Line Treatment in Patients With Advanced Lung Adenocarcinoma Harboring Wild-type Epidermal Growth Factor Receptor (EGFR)
- ClinicalTrials.gov ID
- NCT02691871
- Acronym / sponsor ID
- Ahead-L301
- Conditions
- Lung Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Feb 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.
The purpose of this study is to confirm the safety of Apatinib at a dose level up to 750 mg/d with standard therapy of docetaxel (60 mg/m²) in advanced lung adenocarcinoma patients harboring wild-type EGFR after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib + Docetaxel | Experimental | Drug: Apatinib (250 mg/d) + Docetaxel (60 mg/m2), Drug: Apatinib (500 mg/d) + Docetaxel (60 mg/m2), Drug: Apatinib (750 mg/d) + Docetaxel (60 mg/m2)Low, medium or high dose of Apatinib (days 3-19, q3w) and Docetaxel (60 mg/m2, day 1, q3w) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years to 65 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1;
- Life expectancy of more than 12 weeks;
- At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy =< 3 months;
- Histologically/cytologically confirmed advanced/metastatic lung adenocarcinoma of stage IV with documented wild-type EGFR;
Key exclusion criteria (23 listed)
- Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment;
- Other malignancy within the past five years other than basal cell skin cancer, or carcinoma in situ of the cervix;
- Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction);
- Major injuries and/or surgery =< 4 weeks prior to registration with incomplete wound healing. Patients who have received radiotherapy (except local palliative radiotherapy), chemotherapy, molecular targeted therapy =< 3 weeks, or nitrosoureas/mitomycin chemotherapy =< 6 weeks prior to registration;
- Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
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 |
|---|---|---|
| Apatinib (250 mg/d) + Docetaxel (60 mg/m2) | Drug | Apatinib + Docetaxel |
| Apatinib (500 mg/d) + Docetaxel (60 mg/m2) | Drug | Apatinib + Docetaxel |
| Apatinib (750 mg/d) + Docetaxel (60 mg/m2) | Drug | Apatinib + Docetaxel |
Primary outcome
Maximum tolerated dose (MTD) of Apatinib in combination with Docetaxel (60 mg/m2)
Time frame: During the first treatment course, up to 3 weeks
Number of Participants Experienced Dose Limited Toxicity (DLT) in Combination Therapy of Apatinib and Docetaxel
Time frame: During the first treatment course, up to 3 weeks
3 secondary outcomes
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 for All Courses
Time frame: Between the first administration of Docetaxel and 28 days after last administration of Apatinib, up to 1 year
Objective Response Rate (ORR)
Time frame: Every 6 weeks from the first treatment course, up to 1 year
Progression-free Survival (PFS)
Time frame: Every 6 weeks from the first treatment course, up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apatinib (250 mg/d) + Docetaxel (60 mg/m2), Apatinib (500 mg/d) + Docetaxel (60 mg/m2) and Apatinib (750 mg/d) + Docetaxel (60 mg/m2) in people with Lung Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 9 inclusion and 23 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 25 Feb 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jie Wang, MD, PhD (+86 13910704669, jiewang_hr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of Apatinib in combination with Docetaxel (60 mg/m2) (time frame: During the first treatment course, up to 3 weeks). The study lists 2 primary outcomes in all. 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 25 Feb 2016.