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A Safety, Tolerability and Preliminary Efficacy Evaluation of CC-90011 Given in Combination With Cisplatin and Etoposide in Subjects With First Line, Extensive Stage Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03850067
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

CC-90011-SCLC-001 is a multicenter, Phase 1b, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently and sequentially to standard of care platinum-based, cisplatin and etoposide, to subjects with first line ES SCLC.

The dose finding part of the study will explore escalating oral doses of CC-90011 in combination with cisplatin and etoposide (chemotherapy), to determine the maximum tolerated dose of CC- 90011 in combination with cisplatin and etoposide to subjects with first line ES SCLC.

The dose finding part of the study will explore escalating oral doses of CC-90011 in combination with cisplatin and etoposide (chemotherapy), to determine the maximum tolerated dose of CC- 90011 in combination with cisplatin and etoposideCC-90011-SCLC-001 is a multicenter, Phase 1b, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently and sequentially to standard of care platinum-based, cisplatin and etoposide, to subjects.


Condition or disease Intervention/treatment Phase
Small Cell Lung Carcinoma Drug: CC-90011 Drug: Cisplatin Drug: Etoposide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Multicenter, Open-label, Dose Finding Study to Assess the Safety, Tolerability, and Preliminary Efficacy of CC-90011 Given in Combination With Cisplatin and Etoposide in First -Line, Extensive Stage Subjects With Small Cell Lung Cancer
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : December 2, 2019
Estimated Study Completion Date : March 20, 2022


Arm Intervention/treatment
Experimental: CC-90011 in combination with Cisplatin and Etoposide
During the Chemotherapy Treatment Period, the dose escalation is designed to explore three dose levels of CC-90011, for example 20, 40, and 60 mg or as determined by Bayesian design, administered orally Days 1 and 8, in combination with cisplatin intravenous (IV) 75 mg/m2, Day 1, and etoposide iv 100 mg/m2 on Days 1, 2, and 3, for 4 cycles of 21 days each. Subjects completing the chemotherapy and being responders as per RECIST 1.1 will enter the Maintenance Treatment Period. Subjects completing 6 cycles of maintenance treatment and continuing on CC-90011 are only required to have clinic visits/assessments performed on Day 1 (± 3 days) of each subsequent cycle (Cycles 6 and higher) unless more frequent visits are clinically indicated.
Drug: CC-90011
CC-90011

Drug: Cisplatin
Cisplatin

Drug: Etoposide
Etoposide




Primary Outcome Measures :
  1. Dose‐Limiting Toxicity (DLT) [ Time Frame: Up to approximately 28 days ]
    Number of participants with DLT

  2. Maximum Tolerated Dose (MTD) [ Time Frame: Up to approximately 28 days ]
    Number of participants with MTD

  3. Adverse Events (AEs) [ Time Frame: Up to approximately 2 years ]
    Number of participants with adverse events


Secondary Outcome Measures :
  1. Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 2 years ]
    Is defined as tumor responses (as assessed by the Investigators) of complete response (CR), partial response (PR) and durable stable disease (SD) (SD of ≥ 4 months duration).

  2. Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]
    Is defined as the percent of subjects whose best response is complete response (CR) or partial response (PR).

  3. Progression-free Survival (PFS) [ Time Frame: Up to approximately 2 years ]
    Is defined as the time from the first dose of study drug to the first occurrence of disease progression or death from any cause.

  4. Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
    Is measured as the time from the first dose of CC-90011 to death due to any cause.

  5. Pharmacokinetics- Cmax [ Time Frame: Up to approximately 2 years ]
    Maximum observed plasma concentration

  6. Pharmacokinetics- AUC [ Time Frame: Up to approximately 2 years ]
    Area under the plasma concentration time-curve

  7. Pharmacokinetics- Tmax [ Time Frame: Up to approximately 2 years ]
    Time to maximum plasma concentration

  8. Pharmacokinetics- t1/2 [ Time Frame: Up to approximately 2 years ]
    Terminal half-life

  9. Pharmacokinetics- CL/F [ Time Frame: Up to approximately 2 years ]
    Apparent clearance

  10. Pharmacokinetics- VzF [ Time Frame: Up to approximately 2 years ]
    Apparent volume of distribution



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subject is 18 to 75 years of age at the time of signing the informed consent form (ICF).
  2. Subject with histological or cytological confirmation of extensive stage SCLC according to 2015 WHO classification (Travis, 2015).
  3. Subject must be able to provide fresh or archival tumor tissues
  4. Subject is found suitable for at least 4 cycles of platinum-based standard chemotherapy.
  5. Subject has at least 1 site of measurable disease per RECIST 1.1.

Exclusion Criteria:

  1. Subject has received anticancer therapy (either approved or investigational, including radiation with curative intent) for SCLC prior to study entry.
  2. Subject has undergone major surgery ≤ 4 weeks or minor surgery ≤ 2 weeks prior to Cycle 1 Day 1 or who has not recovered from surgery.
  3. Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management), or any other significant gastrointestinal (GI) disorder that could affect the absorption of CC- 90011.
  4. Subject with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.
  5. Subject with any hemorrhage/bleeding event > CTCAE Grade 2 or hemoptysis > 1 teaspoon within 4 weeks prior to the first dose.
  6. Subject with symptomatic and untreated or unstable central nervous system (CNS) metastases.
  7. Subject has impaired cardiac function or clinically significant cardiac diseases, including any of the following:

    • Left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO).
    • Complete left bundle branch or bifascicular block.
    • Congenital long QT syndrome.
    • Persistent or clinically meaningful ventricular arrhythmias or atrial fibrillation.
    • QTcF ≥ 480 msec on Screening ECG (mean of triplicate recordings).
  8. Subject has other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mm Hg).
  9. Subject is a pregnant or nursing female.
  10. Subject has known human immunodeficiency virus (HIV) infection.
  11. Subject has known chronic active hepatitis B or C virus (HBV, HCV) infection.
  12. Subject with ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors, thrombin antagonist).
  13. Subject has a history of concurrent second cancers requiring active, ongoing systemic treatment.
  14. Subject has Grade 2 peripheral sensory neuropathy.
  15. Subject with poor bone marrow reserve as assessed by Investigator.
  16. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  17. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  18. Subject has any condition that confounds the ability to interpret data from the study.

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): NCT03850067


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
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France
Hospital Le Timone Recruiting
Marseille Cedex 5, France, 13385
CHU Nantes Hopital Nord Laennec Recruiting
Nantes CEDEX 1, France, 44093
Institut Gustave Roussy Recruiting
Villejuif CEDEX, France, 94805
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I, G.M. Lancisi, G. Salesi" Recruiting
Ancona, Italy, 60126
Polyclinic S. Orsola-Malpighi Recruiting
Bologna, Italy, 40138
Istituto Clinico Humanitas Recruiting
Rozzano (MI), Italy, 20089
Spain
Hospital Universitario Germans Trias i Pujol Recruiting
Barcelona, Spain, 08916
Hospital Doce de Octubre Recruiting
Madrid, Spain, 28041
Hospital Universitario La Fe Recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Zariana Nikolova, MD, PHD Celgene Corporation
Principal Investigator: Oscar Juan Vidal, MD, PhD Hospital Universitario La Fe
Principal Investigator: Stefania Salvagni, MD Azienda Ospedaliero Universitarua, Policlinico S. Orsola Malpighi
Principal Investigator: Rossana Berardi, MD Ospedali Riuniti di Ancona
Principal Investigator: Armando Santoro, MD IRCCS Instituto Clinic Humanitas
Principal Investigator: Benjamin Besse, MD, PhD Gustave Roussy, Ditep

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03850067     History of Changes
Other Study ID Numbers: CC-90011-SCLC-001
U1111-1228-2067 ( Registry Identifier: WHO )
2018-002799-42 ( EudraCT Number )
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Safety
CC-90011
Extensive stage small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action