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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

Brief Summary:
A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic or unresectable, locally advanced malignant solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: HuMax-IL8 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Dose Escalation, Multiple Dose Trial With HuMax-IL8 in Patients With Metastatic or Unresectable, Locally Advanced Malignant Solid Tumors
Study Start Date : August 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pharmacokinetic properties of HuMax-IL8 in patients including AUC (Area Under the Curve) [ Time Frame: From baseline up to 72 hours after infusion ]


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:

  • 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


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): NCT02536469


Locations
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United States, Maryland
National Cancer Institute
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Bristol-Myers Squibb
This trial was conducted previously by Cormorant
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02536469     History of Changes
Other Study ID Numbers: COR01CD101
CA027-001 ( Other Identifier: BMS )
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Neoplasms