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Non-Small Cell Lung CancerPhase 1NCT02914990

Safety, Tolerability and Pharmacokinetic Profile of BPI-15086 in EGFR T790M Mutation-positive NSCLC Patients

A Phase 1 study testing BPI-15086 in people with Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of this study is to evaluate the safety and tolerability of BPI-15086. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
BPI-15086
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
29 Dec 2016to 7 Mar 2019
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

  • Histologically or cytologically confirmed, locally advanced or metastatic NSCLC patients, who is not suitable for surgery or radiotherapy
  • Radiological documentation of disease progression while on a previous continuous EGFR TKI (e.g. icotinib, gefitinib, afatinib, neratinib, dacomitnib, or erlotinib) treatment
  • Patients must fulfil one of the following:
  • Confirmation that the tumour harbours EGFR sensitivity mutation (exon 19 deletion, L858R and L861R, G719X)
  • Must have experienced clinical benefit from EGFR TKIs, according to the Jackman criteria
  • Confirmation of T790M mutation positive after disease progression on EGFR TKIs
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and estimated life expectancy of at least 12 weeks
  • Measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST1.1)
  • Adequate bone marrow, hepatic, and renal function
  • Women: For pre-menopausal women who have a childbearing potential, they must have a pregnancy test within 7 days before starting treatment. The serum or urine pregnancy test must be negative and must be non-lacking; all patients (whether male or female) should be Adequate barrier contraceptive measures during the entire treatment period and 3 months after the end of treatment
  • Have signed Informed Consent Form

Who cannot join

  • Any other malignancy within 5 years of the first dose of study treatment
  • Radiotherapy for target lesion within 4 weeks of the first dose of study treatment.
  • From the treatment of reversible EGFR TKI drugs (e.g. Ectinib, Gefitinib, Erlotinib) to the first use of drugs, the time did not exceed 8 days or 5 half-lives (take the long time)；Irreversible EGFR TKI drugs (e.g. Alfatinib, Neratinib, Dacomitinib) did not last more than 14 days or 5 half-lives (take the long term)
  • Investigational agents or anticancer drugs (Including cytotoxic chemotherapy) from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment
  • Prior treatment with other third generation EGFR TKIs, including osimertinib, rociletinib, EGF816, olmutinib, ASP8273 and avitinib
  • Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment
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  • History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, radiological documentation of idiopathic pulmonary fibrosis at baseline; uncontrolled pleural effusion/pericardial effusion
  • Any evidence of severe or uncontrolled systemic diseases, including CTCAE 2 or higher active infection, uncontrolled hypertension, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease
  • Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
  • History of organ transplant; had surgery or severe injury within 4 weeks
  • 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 >240msec, or QRS> 110 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 in first degree relatives or any concomitant medication known to prolong the QT interval
  • Poorly controlled hyperglycemia(fasting blood glucose level ≥7.0 mmol/L).
  • Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of BPI-15086
  • It is known that the study drug or any of its excipients (microcrystalline cellulose, lactose, crospovidone, hydroxypropyl cellulose, magnesium stearate) are severely allergic
  • CYP3A4 strong inhibitors or inducers or Chinese herbal medicine for anti-tumor indications were used within 1 week before the first dose
  • Abuse of drugs and medical, psychological or social conditions in patients may interfere with participating in the study or assessment of the results of the study
  • Any condition that is unstable or may compromise patient safety and compliance with the study
  • Researchers believe that patients who are not suitable for treatment with this regimen

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: A Phase 1 Study of BPI-15086 in Patients With Epidermal Growth Factor Receptor T790M Mutation-positive Non-Small Cell Lung Cancer Who Have Progressed on Previous EGFR Tyrosine Kinase Inhibitor Therapy

The main objective of this study is to evaluate the safety and tolerability of BPI-15086.

Read the detailed description

The main objective of this study is to evaluate the safety and tolerability of BPI-15086. In addition, the anti-cancer effect of BPI-15086 in EGFR T790M mutation-positive advanced NSCLC patients who have progressed on a previous EGFR tyrosine kinase inhibitor therapy will also be evaluated. Biomarkers related to the efficacy of BPI-15086 will be investigated.

Being tested
BPI-15086
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.

  • BPI-15086Drug

    BPI-15086 is administered once daily with a starting dose of 25 mg in a 21-day cycle. When tolerated, increasing doses of BPI-15086 will be tested in subsequent cohorts, until a maximum tolerated dose is determined.

Study groups in NCT02914990
Study groupRoleWhat they receive
BPI-15086ExperimentalBPI-15086, orally administered daily
Receives: Drug: BPI-15086

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03

    Measured: 18 months

Secondary outcomes (5)

  1. Cmax

    Measured: 4 weeks

  2. Half life

    Measured: 4 weeks

  3. AUC

    Measured: 4 weeks

  4. Objective Response Rate

    Measured: 12 weeks

  5. Progression-Free Survival

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2016 (estimated)
  2. Study start29 Dec 2016
  3. Primary completion7 Mar 2019
  4. Study completion7 Mar 2019

Resources

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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02914990
Sponsor's protocol ID
BTP-26511
Status last verified
Jul 2019
First submitted
20 Sep 2016
Last updated
18 Jul 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BPI-15086 in people with Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. 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 11 inclusion and 20 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 18 Jul 2019. 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?

Adverse events (time frame: 18 months). 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 NCT02914990.

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 18 Jul 2019.

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