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Trial record 1 of 1 for:    NCT02536469
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HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid Tumors

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ClinicalTrials.gov Identifier: NCT02536469
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
This trial was conducted previously by Cormorant
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE August 23, 2015
First Posted Date  ICMJE August 31, 2015
Last Update Posted Date February 3, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
Proportion of patients who experience DLTs (Dose Limiting Toxicity) 28 days following the first dose of HuMax-IL8, as well as all DLTs occurring during the study thereafter. [ Time Frame: From cycle 1 day 1 up to 28 days ]
The primary endpoint of this study is the proportion of patients who experience DLTs. The MTD (Maximum Tolerated Dose) will be determined based on the dose escalation cohorts. The evaluation period for DLTs will be 28 days following the first dose of HuMax-IL8
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02536469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
Pharmacokinetic properties of HuMax-IL8 in patients including AUC (Area Under the Curve) [ Time Frame: From baseline up to 72 hours after infusion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid Tumors
Official Title  ICMJE A Phase Ib, Dose Escalation, Multiple Dose Trial With HuMax-IL8 in Patients With Metastatic or Unresectable, Locally Advanced Malignant Solid Tumors
Brief Summary A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic or unresectable, locally advanced malignant solid tumors.
Detailed Description All human subjects with a diagnosis of incurable solid tumors are eligible for the dose-escalation phase of this study. This study consists of two phases, the dose-escalation phase and the expansion phase. Subjects will be treated with the study treatment until any off-treatment criteria are met. The safety and efficacy will be assessed until the end of treatment or for a maximum of 52 weeks. In addition, a separate visit will be performed at the time of disease progression if the patient has a progression between end of treatment and 52 weeks. The patients will be followed up for overall survival until the study closure. The study will be closed when all enrolled patients have been followed up for at least 52 weeks or have died.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: HuMax-IL8
HuMax-IL8 drug product intended for intravenous infusion. Subjects will be treated every 2 weeks. Every 2 doses (4 weeks) will be considered 1 cycle
Other Name: BMS-968253
Study Arms  ICMJE Experimental: HuMax-IL8
HuMax-IL8 drug product intended for intravenous infusion. Subjects will be treated every 2 weeks. Every 2 doses (4 weeks) will be considered 1 cycle
Intervention: Drug: HuMax-IL8
Publications * Bilusic M, Heery CR, Collins JM, Donahue RN, Palena C, Madan RA, Karzai F, Marté JL, Strauss J, Gatti-Mays ME, Schlom J, Gulley JL. Phase I trial of HuMax-IL8 (BMS-986253), an anti-IL-8 monoclonal antibody, in patients with metastatic or unresectable solid tumors. J Immunother Cancer. 2019 Sep 5;7(1):240. doi: 10.1186/s40425-019-0706-x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2016)
15
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2015)
44
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have metastatic or unresectable locally advanced malignant solid tumor.
  • Patients may have measurable or non-measurable but evaluable disease.
  • Patients with surgically resected metastatic disease at high risk of relapse are also eligible.
  • Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease.
  • Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy
  • Age ≥ 18 years. .
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1 (Karnofsky ≥ 70%).
  • Patients must have normal organ and hematologic function therapy
  • Patients must have baseline pulse oximetry > 90% on room air

Exclusion Criteria:

  • Pregnant women or women presently breast-feeding
  • Concurrent treatment for cancer
  • Chronic hepatitis B or C infection.
  • Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
  • Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • Active autoimmune diseases requiring treatment or a history of autoimmune disease.
  • Concurrent use of systemic steroids
  • Patients who are receiving any other investigational agents
  • Patients with untreated central nervous system metastases or local treatment of brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agent used in study.
  • Serious or uncontrolled intercurrent illness
  • HIV-positive patients are ineligible
  • Patients unwilling to use adequate contraception

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02536469
Other Study ID Numbers  ICMJE COR01CD101
CA027-001 ( Other Identifier: BMS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE This trial was conducted previously by Cormorant
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP