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A Safety and Efficacy Study of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas

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ClinicalTrials.gov Identifier: NCT02875223
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with relapsed and/or refractory solid tumors (including neuroendocrine carcinomas (NEC)) and Non-Hodgkin's lymphomas (NHLs). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Neoplasms Drug: CC-90011 Phase 1

Detailed Description:

Parts A and B will consist of 3 periods: Screening, Treatment and Follow-up. Screening Period The Screening Period starts 28 days (± 3 days) prior to first dose of CC-90011. The informed consent document (ICD) must be signed and dated by the subject and the administering staff prior to the start of any other study procedures. All screening tests and procedures must be completed within the 28 days (±3 days) prior to the first dose of CC-90011.

Treatment Period During the Treatment Period, CC-90011 will initially be administered orally in each 4-week (28 day) Cycle.

Follow-up Period In the Follow-up Period, subjects will be followed for 28 days (± 3 days) after the last dose of CC-90011 for safety.

After the Safety Follow-up visit, all subjects will be followed every subsequent 3 months (± 2 weeks) for survival follow-up for up until 2 years or until death, lost to follow-up, or the End of Trial, whichever occurs first.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of CC-90011 in Subjects With Advanced Solid Tumors and Non-Hodgkin Lymphomas
Actual Study Start Date : August 31, 2016
Estimated Primary Completion Date : March 24, 2021
Estimated Study Completion Date : June 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CC-90011 Administration
CC-90011 will be administered once weekly in the morning on an empty stomach (ie, ≥ 1 hour before breakfast) with at least 240 mL of water after an overnight fast lasting ≥ 4 hours in both Parts A and B.
Drug: CC-90011



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

  2. Adverse Events (AEs) [ Time Frame: Up to 6 years ]
    Number of participants with adverse events


Secondary Outcome Measures :
  1. Clinical Benefit Rate (CBR) [ Time Frame: Up to 6 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 6 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 6 years ]
    Is defined as the time from the first dose of CC-90011 to the first occurrence of disease progression or death from any cause.

  4. Overall Survival (OS) [ Time Frame: Up to 6 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 6 years ]
    Maximum observed plasma concentration

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

  7. Pharmacokinetics ‐Tmax [ Time Frame: Up to 6 years ]
    Time to maximum plasma concentration

  8. Pharmacokinetics ‐t1/2 [ Time Frame: Up to 6 years ]
    Terminal half-life

  9. Pharmacokinetics ‐CL/F [ Time Frame: Up to 6 years ]
    Apparent total body clearance

  10. Pharmacokinetics ‐Vz/F [ Time Frame: Up to 6 years ]
    Apparent volume of distribution



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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:

Subjects must satisfy the following criteria to be enrolled in the study:

1. ≥ 18 years of age 2. Part A:

  • Subjects with histological or cytological confirmation of advanced unresectable solid tumors (including Grade 2 neuroendocrine neoplasms (NENs)/ neuroendocrine tumors (NETs), small cell lung cancer (SCLC), and other neuroendocrine carcinomas (NECs)) or advanced Non-Hodgkin's lymphomas (NHL) (diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL) or marginal cell lymphoma MZL).) 3. Part B:
  • Enrichment for bronchial and prostate NENs will be targeted. Subjects with histological or cytological confirmation of advanced unresectable solid tumors (including G2 NENs/NETs, SCLC, and other NECs) which fall under one of the following categories (G1 NETs are excluded from this study):
  • NECs and G2 NENs/NETs must have:

    1. Appropriate pathological features according to WHO classification
    2. Expression of neuroendocrine markers
    3. Mitotic count ≥ 2 per 10 HPF or ≥ 2 per 2mm2 and/or ≥ 3% Ki67 index

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  1. low grade (G1) neuroendocrine tumors (<2 per high power fields (HPF) or < 2 per mm2 and/or ≤ 2% Ki67 index) such as carcinoid are excluded.
  2. Subject has received anti-cancer therapy (either approved or investigational) ≤ 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1..

    - < 42 days for prior nitrosureas or mitomycin C

  3. Toxicities resulting from prior systemic cancer therapies must have resolved to ≤National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to starting CC-90011 treatment (with exception of grade 2 peripheral neuropathy and alopecia).
  4. Prior autologous stem cell transplant ≤ 3 months before first dose or those who have not recovered.
  5. Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning.
  6. Subject has undergone major surgery ≤ 4 weeks or minor surgery ≤ 2 weeks prior to Cycle 1 Day 1 or who have not recovered from surgery.
  7. Subject has completed any radiation treatment < 4 weeks prior to Cycle 1 Day 1 or < 2 weeks for palliative bone radiotherapy (single fraction). Subjects with > 25% of myelopoetic BM radiation are not allowed to be enrolled on this study.
  8. 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 GI disorder that could affect the absorption of CC-90011.
  9. Subject with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.
  10. Subject with any hemorrhage/bleeding event > CTCAE Grade 2 or haemoptysis > 1 teaspoon within 4 weeks prior to the first dose
  11. Symptomatic and untreated or unstable central nervous system (CNS) metastases as per protocol.
  12. Subject with SCLC that has history of interstitial lung disease (ILD) OR a history of pneumonitis that has required oral or Intra Venous (IV) steroids
  13. Subject has known symptomatic acute or chronic pancreatitis.
  14. Subject has impaired cardiac function or clinically significant cardiac diseases, as per protocol.
  15. Subject has other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mm Hg).
  16. Subject is a pregnant or nursing female.
  17. Subject has known Human immunodeficiency virus (HIV) infection.
  18. Subject has known chronic active hepatitis B or C virus (HBV, HCV) infection.
  19. Subject with ongoing treatment with chronic, therapeutic dosing of anti-coagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors, thrombin antagonist). Low dose low molecular weight heparin for catheter maintenance and for short-term prophylaxis for subjects with prior PE and DVT are permitted under careful consideration by the Investigator.
  20. Subject has a history of concurrent second cancers requiring active, ongoing systemic treatment.
  21. Subject has any significant medical condition (eg, active or uncontrolled infection or renal disease), laboratory abnormality, or psychiatric illness that would prevent the subject from participating (or compromise compliance) in the study or would place the subject at unacceptable risk if he/she were to participate in the study.
  22. 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): NCT02875223


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

Locations
France
Centre Georges Francois Leclerc Recruiting
Dijon, France, 21079
Institut Paoli Calmettes Recruiting
Marseille Cedex 9, France, 13273
Institut Gustave Roussy Recruiting
Villejuif Cedex, France, 94805
Italy
Bologna University Not yet recruiting
Bologna, Italy, 40123
Istituto Nazionale Dei Tumori Not yet recruiting
Milano, Italy, 20133
Istituto Europeo di Oncologia Not yet recruiting
Milano, Italy, 20141
Spain
Hospital Universitario Vall D hebron Recruiting
Barcelona, Spain, 08035
Fundacion Jimenez Daaz Recruiting
Madrid, Spain, 28040
Hospital Universitario Marques de Valdecilla Recruiting
Santander, Spain, 39008
United Kingdom
Royal Marsden Hospital Recruiting
London, United Kingdom, SW3 6JJ
Freeman Hospital Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Celgene
Investigators
Study Director: Zariana Nikolova, MD, PhD Celgene Corporation
Principal Investigator: Johann De Bono, MD, PhD Royal Marsden NHS Foundation Trust
Principal Investigator: Antoine Hollebecque, MD Gustave Roussy

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02875223     History of Changes
Other Study ID Numbers: CC-90011-ST-001
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Keywords provided by Celgene:
Safety
CC-90011
Relapsed and/or Refractory Solid Tumors
Non-Hodgkin's Lymphomas

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases