Non-Small Cell Lung CancerPhase 1NCT02374645
A Phase I Study of Safety and Pharmacokinetics of Volitinib in Combination With Gefitinib in EGFR(+) NSCLC
A Phase 1 study testing Volitinib and gefitinib in people with Non-Small Cell Lung Cancer, run by Hutchison Medipharma Limited at 1 site in China.
Trial summary
This is a Phase 1b, open-label, multicentre study of AZD6094 in combination with gefitinib in patients with epidermal growth factor receptor (EGFR) mutation positive (m+) and progressed on EGFR Tyrosine kinase inhibitor (TKI) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Volitinib and gefitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to 14 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures. If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study there will be no penalty or loss of benefit to the patient and he or she will not be excluded from other aspects of the study.
- Male or female aged at least 18 years and older.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC patients who are harbouring an EGFR mutation known to be associated with EGFR-TKI sensitivity (including exon 19 deletion, L858R, L861Q, G719X). Local test for EGFR mutation is acceptable. In the expansion phase, patients must have a positive cMet test by a central laboratory. Safety run-in phase: EGFR mutation positive. A local EGFR test result is acceptable Expansion phase: EGFR mutation positive and cMet-positive. cMet test is performed by a central lab.
- Radiological documentation of disease progression while on a previous continuous treatment with EGFR-TKI eg, gefitinib or erlotinib. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study. The patients must have been treated with an EGFR-TKI with objective clinical benefit (CR/PR) or SD for 3 months, and who have subsequently shown radiological progression on treatment. In addition, other lines of therapy may have been given.
- At least 1 lesion, not previously irradiated, not biopsied during the screening period, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
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- Women should agree to use adequate contraceptive measures (as defined in section 5.1), should not be breast feeding, and must have a negative pregnancy test prior to start of dosing or if of child-bearing potential or of non-child- bearing potential must have evidence of this by fulfilling 1 of the following criteria at screening:
- Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- Women under 50 years of age would be considered postmenopausal if they have been amenorrhoeic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in the postmenopausal range for the institution.
- Sexually active male patients should be willing to use barrier contraception; ie, condoms.
- For inclusion in the genetic research, patients must provide informed consent for genetic research.
Who cannot join
- Intervention with any of the following:
- Treatment with an EGFR-TKI within approximately 5x half-life (eg, within 8 days for erlotinib, gefitinib or afatanib, within 10 days for dacomitinib) of the first dose of study treatment
- Any cytotoxic chemotherapy, investigational agents or other anticancer drugs for the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment
- Patients currently receiving (or unable to stop use at least 2 weeks) prior to receiving the first dose of AZD6094, medications known to be strong inhibitors of CYP1A2 (Appendix E)
- Prior or current treatment with AZD6094 or another cMet inhibitor (eg, foretinib, crizotinib, cabozantinib, onartuzumab)
- Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.
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- Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed ≥4 weeks of the first dose of study treatment.
- Major surgical procedure, (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study
- With the exception of alopecia and CTCAE Grade 2, prior chemotherapy-related neuropathy, any unresolved toxicities from prior therapy and/or pre-study biopsies greater than CTCAE Grade 1 at the time of starting study treatment
- Have non-measurable disease at baseline per RECIST v1.1. To ensure that the patient will be able to complete the evaluable period of the study and the assessment of progression can be performed according to the RECIST v1.1 criteria and the relevant treatment decisions applied OR can be summarised for patients with measurable disease at baseline
- Presence of other active cancers, or history of treatment for invasive cancer ≤5 years. Patients with Stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.
- Current leptomeningeal metastases or spinal cord compression. Brain metastases are only permitted if treated, asymptomatic, and stable (not requiring steroids for at least 4 weeks prior to start of study treatment).
- Patients with known tumour thrombus or deep vein thrombosis are eligible if stable on low molecular weight heparin for ≥4 weeks.
- As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, active bleeding diatheses, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol; including evidence of active infection including hepatitis B (HBV) surface antigen, hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- Any serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive IP, such as conditions associated with frequent diarrhoea.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) >470 msec obtained from triplicate ECGs
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG; eg, complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 msec
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval- Inadequately controlled hypertension (ie, systolic blood pressure (BP) >160 mmHg or diastolic BP >100 mmHg (patients with values above these levels must have their BP controlled with medication prior to starting treatment).
- Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest
- Symptomatic heart failure - New York Heart Association (NYHA) Grade II-IV
- Unstable angina pectoris
- Acute myocardial infarction
- Uncontrolled angina (Canadian Cardiovascular Society Grade II-IV despite medical therapy)
- Stroke or transient ischemic attack in the last 6 months
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- Absolute neutrophil count <1.5x109/L
- Platelet count <100x109/L
- Haemoglobin <90 g/L
- Alanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases
- Aspartate aminotransferase (AST) >2.5 times ULN if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases
- Total bilirubin (TBL) >1.5 times ULN, TBL >3 times ULN in patients with documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or in the presence of liver metastases
- Creatinine >1.5 times ULN concurrent with creatinine clearance <50 mL/min (measured or calculated by Cockcroft and Gault equation), confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD6094 or gefitinib
- History of hypersensitivity to active or inactive excipients of AZD6094 or gefitinib or drugs with a similar chemical structure or class to AZD6094 or gefitinib. Unable to undergo an MRI or contrast CT procedures
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. Insufficient lung function dependent on supplemental oxygen (determined by either clinical examination or an arterial oxygen tension (PaO2) of <70 Torr)
- Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
- Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the study site)
- Previous enrolment in the present study
- In addition, the following are considered criteria for exclusion from the exploratory genetic research:
- Previous allogeneic bone marrow transplant
- Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumour Activity of Volitinib in Combination With Gefitinib in Patients With Epidermal Growth Factor Receptor-mutated Non-small Cell Lung Cancer Who Have Progressed on Epidermal Growth Factor Receptor Inhibitor Treatment
This is a Phase 1b, open-label, multicentre study of AZD6094 in combination with gefitinib in patients with epidermal growth factor receptor (EGFR) mutation positive (m+) and progressed on EGFR Tyrosine kinase inhibitor (TKI) treatment.
Read the detailed description
A total of 53 patients will be enrolled in the safety run-in and expansion phases:
- Safety run-in phase - patients with EGFR mutation-positive (EGFRm+), locally advanced or metastatic non-small cell lung cancer (NSCLC), who have progressed on previous EGFT TKI treatment.In the safety run-in phase of the study, the sample size may vary, depending on the number of dose levels evaluated and the number of Dose Limiting Toxicities (DLTs) observed in each cohort.
- Expansion phase - patients who are EGFRm+ and cMet-positive with locally advanced or metastatic NSCLC, who have progressed on previous EGFR-TKI treatment.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Volitinib, gefitinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolitinibDrug
Also called AZD6094, HMPL-504
600mg or 800mg QD: Patients may continue to receive the treatment as long as they are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
gefitinibDrug
Also called Iressa, ZD1839
250mg QD: Patients may continue to receive the treatment as long as they are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| Volitinib (AZD6094) 600mg + gefitinib 250 mg | Experimental | Cohort 1: Volitinib（AZD6094） 600 mg od + gefitinib 250 mg od Receives: Drug: Volitinib; Drug: gefitinib |
| Volitinib (AZD6094) 800mg + gefitinib 250 mg | Experimental | Cohort 2: Volitinib（AZD6094） 800 mg od + gefitinib 250 mg od Receives: Drug: gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events and serious adverse events
the grade of AE event according to CTC AE 4.0
Measured: From ICF signed to within 28 days after the last dose
Secondary outcomes (4)
The Pharmacokinetics (PK) profiles of AZD6094
Peak Plasma Concentration (Cmax)
Measured: Cycle 1 Day1 and Day 15
The Pharmacokinetics (PK) profiles of AZD6094
Area under the plasma concentration versus time curve (AUC)
Measured: Cycle 1 Day1 and Day 15
Progression-free survival (PFS）
6-months PFS, 12 months PFS and 24 month PFS
Measured: from enrolled until progression or death due to any cause, assessed up to 2 year
Disease control rate（DCR)
CR+PR+SD
Measured: 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startApr 2015
- Primary completion18 Feb 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, Prof., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374645
- Sponsor's protocol ID
- D5080C00001
- Status last verified
- Apr 2020
- First submitted
- 12 Feb 2015
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang JJ, Fang J, Shu YQ, Chang JH, Chen GY, He JX, Li W, Liu XQ, Yang N, Zhou C, Huang JA, Frigault MM, Hartmaier R, Ahmed GF, Egile C, Morgan S, Verheijen RB, Mellemgaard A, Yang L, Wu YL. A phase Ib study of the highly selective MET-TKI savolitinib plus gefitinib in patients with EGFR-mutated, MET-amplified advanced non-small-cell lung cancer. Invest New Drugs. 2021 Apr;39(2):477-487. doi: 10.1007/s10637-020-01010-4. Epub 2020 Oct 14.
PubMed 33052556
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumour Activity of Volitinib in Combination With Gefitinib in Patients With Epidermal Growth Factor Receptor-mutated Non-small Cell Lung Cancer Who Have Progressed on Epidermal Growth Factor Receptor Inhibitor Treatment
- ClinicalTrials.gov ID
- NCT02374645
- Acronym / sponsor ID
- D5080C00001
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- Apr 2015 (actual)
- Primary completion
- 18 Feb 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 2 Mar 2015 (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.
This is a Phase 1b, open-label, multicentre study of AZD6094 in combination with gefitinib in patients with epidermal growth factor receptor (EGFR) mutation positive (m+) and progressed on EGFR Tyrosine kinase inhibitor (TKI) treatment.
Detailed description
A total of 53 patients will be enrolled in the safety run-in and expansion phases:
- Safety run-in phase - patients with EGFR mutation-positive (EGFRm+), locally advanced or metastatic non-small cell lung cancer (NSCLC), who have progressed on previous EGFT TKI treatment.In the safety run-in phase of the study, the sample size may vary, depending on the number of dose levels evaluated and the number of Dose Limiting Toxicities (DLTs) observed in each cohort.
- Expansion phase - patients who are EGFRm+ and cMet-positive with locally advanced or metastatic NSCLC, who have progressed on previous EGFR-TKI treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volitinib (AZD6094) 600mg + gefitinib 250 mg | Experimental | Drug: Volitinib, Drug: gefitinibCohort 1: Volitinib（AZD6094） 600 mg od + gefitinib 250 mg od |
| Volitinib (AZD6094) 800mg + gefitinib 250 mg | Experimental | Drug: gefitinibCohort 2: Volitinib（AZD6094） 800 mg od + gefitinib 250 mg od |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of informed consent prior to any study specific procedures. If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study there will be no penalty or loss of benefit to the patient and he or she will not be excluded from other aspects of the study.
- Male or female aged at least 18 years and older.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC patients who are harbouring an EGFR mutation known to be associated with EGFR-TKI sensitivity (including exon 19 deletion, L858R, L861Q, G719X). Local test for EGFR mutation is acceptable. In the expansion phase, patients must have a positive cMet test by a central laboratory. Safety run-in phase: EGFR mutation positive. A local EGFR test result is acceptable Expansion phase: EGFR mutation positive and cMet-positive. cMet test is performed by a central lab.
- Radiological documentation of disease progression while on a previous continuous treatment with EGFR-TKI eg, gefitinib or erlotinib. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study. The patients must have been treated with an EGFR-TKI with objective clinical benefit (CR/PR) or SD for 3 months, and who have subsequently shown radiological progression on treatment. In addition, other lines of therapy may have been given.
- At least 1 lesion, not previously irradiated, not biopsied during the screening period, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements.
Key exclusion criteria (42 listed)
- Intervention with any of the following:
- Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed ≥4 weeks of the first dose of study treatment.
- Major surgical procedure, (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study
- With the exception of alopecia and CTCAE Grade 2, prior chemotherapy-related neuropathy, any unresolved toxicities from prior therapy and/or pre-study biopsies greater than CTCAE Grade 1 at the time of starting study treatment
- Have non-measurable disease at baseline per RECIST v1.1. To ensure that the patient will be able to complete the evaluable period of the study and the assessment of progression can be performed according to the RECIST v1.1 criteria and the relevant treatment decisions applied OR can be summarised for patients with measurable disease at baseline
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 |
|---|---|---|
| VolitinibAlso: AZD6094, HMPL-504600mg or 800mg QD: Patients may continue to receive the treatment as long as they are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. | Drug | Volitinib (AZD6094) 600mg + gefitinib 250 mg |
| gefitinibAlso: Iressa, ZD1839250mg QD: Patients may continue to receive the treatment as long as they are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. | Drug | Volitinib (AZD6094) 600mg + gefitinib 250 mg, Volitinib (AZD6094) 800mg + gefitinib 250 mg |
Primary outcome
Number of adverse events and serious adverse events
Time frame: From ICF signed to within 28 days after the last dose
the grade of AE event according to CTC AE 4.0
4 secondary outcomes
The Pharmacokinetics (PK) profiles of AZD6094
Time frame: Cycle 1 Day1 and Day 15
The Pharmacokinetics (PK) profiles of AZD6094
Time frame: Cycle 1 Day1 and Day 15
Progression-free survival (PFS）
Time frame: from enrolled until progression or death due to any cause, assessed up to 2 year
Disease control rate（DCR)
Time frame: 12 weeks and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 33052556Yang JJ, Fang J, Shu YQ, Chang JH, Chen GY, He JX, Li W, Liu XQ, Yang N, Zhou C, Huang JA, Frigault MM, Hartmaier R, Ahmed GF, Egile C, Morgan S, Verheijen RB, Mellemgaard A, Yang L, Wu YL. A phase Ib study of the highly selective MET-TKI savolitinib plus gefitinib in patients with EGFR-mutated, MET-amplified advanced non-small-cell lung cancer. Invest New Drugs. 2021 Apr;39(2):477-487. doi: 10.1007/s10637-020-01010-4. Epub 2020 Oct 14.
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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.
Yilong Wu, Prof. principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Volitinib and gefitinib in people with Non-Small Cell Lung Cancer, run by Hutchison Medipharma Limited at 1 site in China.
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 12 inclusion and 42 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: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events and serious adverse events (time frame: From ICF signed to within 28 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374645, which also lists 1 linked publication.
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 24 Apr 2020.