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Advanced Solid TumorsPhase 1NCT03117101

Study of the AL3810 in the Treatment of Advanced Solid Tumor

A Phase 1 study testing Lucitanib in people with Advanced Solid Tumors, run by Haihe Biopharma 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

This was a monocentric, open label, non-randomised, non-comparative, dose-finding phase I study Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
Lucitanib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteChina
Study dates
Mar 2014to Sep 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chinese male or female patient aged ≥ 18 years old and ≤ 70 years old.
  • Estimated life expectancy ≥ 12 weeks.
  • Histologically or cytologically confirmed, locally advanced or metastatic solid tumor, refractory to standard therapy or no standard therapy available.
  • Full recovery (to grade ≤ 1) from any prior surgical procedure(s) and from reversible side effects of prior therapy for cancer including radiation therapy, chemotherapy, small molecule therapeutics and immunotherapy.
  • Patients should be evaluable according to RECIST criteria, version 1.1.
  • Adequate haematological, hepatic and renal functions:
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  • Absolute neutrophil count (ANC) ≥ 1.5x 10^9/L Platelet counts ≥ 100 x 10^9/L. Haemoglobin ≥ 9 g/dL. Creatinine clearance > 50 mL/min (assessed with MDRD formula). Proteinuria qualitative test < 1+. If proteinuria qualitative test ≥ 1+, proteinuria over 24 hours should be < 1.0 g/24hrs.
  • INR ≤ 1.5. AST, ALT ≤ 1.5 x Upper Limit of Normal Value (ULN) (≤ 3 x ULN in case of liver metastasis).
  • Bilirubin < 1.5 x ULN.
  • Eastern Co-operative Group (ECOG) performance status ≤ 1.
  • Ability to swallow oral capsules.
  • Negative serum pregnancy test at screening in women of childbearing potential within 7 days prior the study drug intake.
  • Willingness and ability to comply with study procedures.
  • Signed written Informed Consent Form.

Who cannot join

  • Participation in another therapeutic clinical trial at the same time or within 4 weeks prior to first AL3810 intake. In case of involvement in a non-interventional clinical trial (e.g. epidemiological study), inclusion in the present study is possible.
  • Foreseeable poor compliance to the study procedures.
  • Known active central nervous system (CNS) metastases not controlled by prior surgery or radiotherapy and/or low dose steroids.
  • Active second malignancy or history of other malignancy within 2 years, with the exception of non-melanoma skin cancers or carcinoma in situ (CIS) of the breast or cervix or controlled, superficial carcinoma of the bladder.
  • Chemotherapy including biologic/targeted therapy or immunological agents within 4 weeks or 5 half-lives of the agent, whichever the longest, before inclusion.
  • Previous treatment with bevacizumab within 3 months before the first day of AL3810 administration.
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  • Patients who received radiotherapy within 4 weeks of starting study treatment.
  • Major surgery within 4 weeks before first day of study drug administration.
  • History of clinically significant or uncontrolled cardiac disease, including congestive heart failure (New York Heart Association functional classification ≥ 3), angina, myocardial infarction or ventricular arrhythmia.
  • Significant cardiovascular disease or condition, including:
  • Congestive heart failure requiring therapy. Ventricular and/or supra-ventricular arrhythmia requiring therapy. Severe conduction disturbance (including QTc interval prolongation > 450 msec [corrected], history of severe arrhythmia, or history of familial arrhythmia [e.g., Wolff-Parkinson-White syndrome]).
  • Angina pectoris requiring therapy. Left ventricular ejection fraction (LVEF) < 50% evaluated by cardiac ultrasound (ECHO) or Multi Gated Acquisition Scan (MUGA).
  • Myocardial infarction (MI) within 6 months prior to administration of the first dose.
  • Cardiovascular disease > Class I, according to the New York Heart Association's (NYHA) Functional Criteria.
  • Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg with optimized antihypertensive therapy or patients treated with ≥2 antihypertensive agents) or systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg with or without antihypertensive therapy.
  • Patients with thromboembolic events < 12 months prior to treatment start or at high risk of such events.
  • Ongoing treatment with warfarin or other oral anticoagulant.
  • Unavoidable concomitant treatment with any drug known for potential risk of causing Torsades de Pointes.
  • Serum potassium (K+) levels below LLN or 3.0 mmol/L at screening.
  • Patients who received administration of strong inhibitors of CYP2C8 and/or CYP3A4 or strong inducers of CYP3A4 within 7 days before the first dose of AL3810 or have on-going requirements for these medications (appendix 15).
  • Significant gastrointestinal abnormalities, including ulcerative colitis, chronic diarrhoea associated with intestinal malabsorption, Crohn's disease, or decided by investigator.
  • Known pre-existing clinically significant disorder of the hypothalamic-pituitary axis, thyroid and adrenal gland.
  • Serious/active bacterial, viral or fungal infection (including known active human immunodeficiency virus [HIV] infection) requiring systemic treatment.
  • Concomitant uncontrolled severe systemic disease (e.g., uncontrolled diabetes mellitus, etc.).
  • Psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary study procedures.
  • Known organ dysfunction which would either compromise the patient's safety or interfere with the evaluation of AL3810.
  • Men and women of child bearing potential unable or unwilling to employ effective contraception (abstinence, barrier method with spermicide, intrauterine device, or steroidal contraceptive for women and barrier method) during the study and for 6 months thereafter.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: An Open-label, Dose-finding Phase I Study to Determine the Maximum Tolerated Dose, Recommended Dose, Pharmacokinetics, Pharmacodynamics of the Dual -VEGFR-FGFR Tyrosine Kinase Inhibitor, AL3810, Givenorally as Single Agent to Patients With Advanced Solid Tumours

This was a monocentric, open label, non-randomised, non-comparative, dose-finding phase I study

Read the detailed description

Methodology:

This was a monocentric, open label, non-randomised, non-comparative, dose-finding phase I study with a traditional 3+3 design, conducted in Chinese patients with advanced solid tumours without an established therapeutic alternative.This study was performed in strict accordance with Good Clinical Practice including the archiving of essential documents.

Being tested
Lucitanib
Keywords
Tolerability Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LucitanibDrug

    Also called AL3810

Study groups in NCT03117101
Study groupRoleWhat they receive
Dose escalation/ Dose extension of LucitanibExperimentalDose escalation: Dose Level -1: 5 mg.Dose Level 1:.10 mg.Dose Level 2: 15 mg.Dose Level 3: 20 mg. Dose extension: Once the MTD was reached, the MTD-5 mg dose level was to be extended in order to enrol up to 12 patients (number of patients was to be determined regarding safety data) to better assess the toxicity profile, PK profile and antitumor activity.
Receives: Drug: Lucitanib

What is being measured

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

  1. Identify Dose-limiting toxicity (DLT)

    To assess the tolerability of AL3810 in patients with advanced solid tumors

    Measured: 35 days

  2. Identify maximum tolerated dose (MTD)

    To assess the tolerability of AL3810 in patients with advanced solid tumors

    Measured: 35 days

Secondary outcomes (6)

  1. Cmax (maximum plasma concentration)

    Metabolism profiling of AL3810 and its potential metabolites in plasma The potential food interaction on metabolism profile of AL 3810 in plasma

    Measured: Day0,Day8,Day15,Day22,Day29,Day57

  2. Tmax (time to maximum plasma concentration)

    Metabolism profiling of AL3810 and its potential metabolites in plasma The potential food interaction on metabolism profile of AL 3810 in plasma

    Measured: Day0,Day8,Day15,Day22,Day29,Day57

  3. AUC (area under the plasma concentration-time curve)

    Metabolism profiling of AL3810 and its potential metabolites in plasma The potential food interaction on metabolism profile of AL 3810 in plasma

    Measured: Day0,Day8,Day15,Day22,Day29,Day57

  4. Objective response rate (ORR)

    Tumor will be evaluated according to RECIST-1.1. CT or MRI can be used for tumor imaging at the investigator's discretion

    Measured: 8 weeks

  5. progression free survival (PFS)

    Tumor will be evaluated according to RECIST-1.1. CT or MRI can be used for tumor imaging at the investigator's discretion

    Measured: 8 weeks

  6. 10.CBR (clinical benefit rate)

    Tumor will be evaluated according to RECIST-1.1. CT or MRI can be used for tumor imaging at the investigator's discretion

    Measured: 8 weeks

Timeline

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

  1. First posted17 Apr 2017
  2. Study startMar 2014
  3. Primary completionSep 2016
  4. Study completionSep 2016

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03117101
Sponsor's protocol ID
CL1-80881-005
Status last verified
Apr 2017
First submitted
16 Dec 2016
Last updated
17 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lucitanib in people with Advanced Solid Tumors, run by Haihe Biopharma 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 14 inclusion and 27 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 17 Apr 2017. 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?

Identify Dose-limiting toxicity (DLT) (time frame: 35 days). 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?

On the ClinicalTrials.gov record for NCT03117101.

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 17 Apr 2017.

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