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Phase I Study of a Selective ALK Inhibitor PLB1003 in Patients With ALK+ NSCLC.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03130881
Recruitment Status : Unknown
Verified April 2017 by Beijing Pearl Biotechnology Limited Liability Company.
Recruitment status was:  Recruiting
First Posted : April 27, 2017
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Beijing Pearl Biotechnology Limited Liability Company

Brief Summary:
This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1003.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: PLB1003 Phase 1

Detailed Description:

This is a Phase I, open-label study of PB1003 administered orally to patients with ALK-positive (ALK+) advanced NSCLC. The study includes a Dose-escalation Part (part A) and a Dose Expansion Part (part B). The aim of the part A is to estimate the MTD and to identify the dose limited toxicity(DLT) and the recommended phase II dose (RP2D) for PLB1003 single agent as well as to determine the PK/PD profile. Once response has been observed in certain dose level, then followed by the expansion part to further assess the clinical efficacy and safety of PLB1003 single agent. Aprox 40 patients will be enrolled in PART A, while 12-24 patients for expansion cohort .

PLB1003 is a potent selective ALK inhibitor. PLB1003 acts on cancer by blocking abnormal ALK-mediated signaling, leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer (NSCLC) tumours.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open-label, Multicenter Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of PLB1003 in Patients With ALK-positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date : November 8, 2016
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PLB1003
ALK-positive (ALK+) advanced NSCLC
Drug: PLB1003
PLB1003 is a capsule and is administered orally.




Primary Outcome Measures :
  1. Number of Participants With Dose Limiting Toxicities (DLTs) . [ Time Frame: 18 months. ]
    The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment.


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of PLB1003 and its metabolite. [ Time Frame: Day 1-3 PK Run-in period and Day 1-21 Treatment period ]
    In the study of PK Run-in period, full Pharmacokinetics (PK) profiles of PLB1003 will be obtained following administration of a single oral dose of PLB1003 on Day 1 to Day 2. At multiple-dose, Pharmacokinetics (PK) sampling will include a pre-dose and at the 0.5, 2, 3,4, 6, 9, 10, 12 and 24 hour time points on days 1, 22 of dosing in the first 21-Day cycle of Treatment period, and pre-dose on days 16, 17 and 18 of the first 21-Day cycle of Treatment period.

  2. Maximum plasma concentration observed (Cmax) of PLB1003 and its metabolite. [ Time Frame: Day 1-3 PK Run-in period and Day 1-21 Treatment period ]
    In the study of PK Run-in period, full Pharmacokinetics (PK) profiles of PLB1003 will be obtained following administration of a single oral dose of PLB-1003 on Day 1 to Day 2. At multiple-dose, Pharmacokinetics (PK) sampling will include a pre-dose and at the 0.5, 2, 3,4, 6, 9, 10, 12 and 24 hour time points on days 1, 22 of dosing in the first 21-Day cycle of Treatment period, and pre-dose on days 16, 17 and 18 of the first 21-Day cycle of Treatment period.

  3. Time to Cmax (Tmax) of PLB1003 and its metabolite. [ Time Frame: Day 1-3 PK Run-in period and Day 1-21 Treatment period ]
    In the study of PK Run-in period, full Pharmacokinetics (PK) profiles of PLB1003 will be obtained following administration of a single oral dose of PLB-1003 on Day 1 to Day 2. At multiple-dose, Pharmacokinetics (PK) sampling will include a pre-dose and at the 0.5, 2, 3,4, 6, 9, 10, 12 and 24 hour time points on days 1, 22 of dosing in the first 21-Day cycle of Treatment period, and pre-dose on days 16, 17 and 18 of the first 21-Day cycle of Treatment period.

  4. Preliminary antitumor activity of PLB1003. [ Time Frame: 30 months. ]
    Preliminary antitumor activity of PLB1003 assessed using RECIST1.1.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed Consent Form
  • Age≥18 years
  • Diagnosed with a locally advanced or metastatic non-small cell lung cancer that has progressed despite standard therapy.
  • Must have evidence of ALK positivity from the results of molecular pre-screening evaluations
  • At least one measurable lesion as per RECIST v1.1
  • Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1
  • ECOG Performance Status of 0-2

Exclusion Criteria:

  • Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.
  • Clinically significant, uncontrolled heart diseases. Unstable angina. History of documented congestive heart failure (New York Heart Association functional classification III-IV) .
  • Active peptic ulcer disease or gastritis
  • Major surgery within 4 weeks prior to starting PLB1003
  • Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1003..
  • Pregnant or nursing women
  • Involved in other clinical trials < 30 days prior to Day 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130881


Contacts
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Contact: Peilong Zhang, Ph.D +86-10-64392756 zhangpeilong@pearlbio.cn

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Baohui Han, MD    +86-21-22200000    xkyyhan@gmail.com   
Contact: Tianqing Chu, MD    +86-21-22200000    ctqxkyy@163.com   
Principal Investigator: Baohui Han, MD         
Sub-Investigator: Tianqing Chu, MD         
Sponsors and Collaborators
Beijing Pearl Biotechnology Limited Liability Company
Investigators
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Principal Investigator: Baohui Han, MD Shanghai Chest Hospital
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Responsible Party: Beijing Pearl Biotechnology Limited Liability Company
ClinicalTrials.gov Identifier: NCT03130881    
Other Study ID Numbers: HMO-PLB1003-20160828
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms