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Addition of X4P-001 to Nivolumab Treatment in Participants With Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02923531
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
X4 Pharmaceuticals

Brief Summary:
The purpose of this study is to determine if the combination of X4P-001 plus nivolumab is safe and tolerable. Secondly, the study will investigate if adding X4P-001 to nivolumab treatment has an effect on the body and the cancer tumor, in participants receiving nivolumab but not exhibiting a radiological response.

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Drug: X4P-001 Drug: Nivolumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1B/2A Trial Adding X4P-001 in Patients Receiving Nivolumab for Treatment of Advanced Clear Cell Renal Cell Carcinoma
Actual Study Start Date : December 7, 2016
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : August 8, 2018


Arm Intervention/treatment
Experimental: X4P-001 Plus Nivolumab
Participants will receive X4P-001 400 milligrams (mg) (as 4 capsules of 100 mg each) orally once daily in combination with nivolumab 240 mg intravenous (IV) infusion (over 60 minutes) every 2 weeks. Study treatment will be administered in 28-day cycles and will continue until treatment-limiting toxicity or disease progression.
Drug: X4P-001
X4P-001 will be administered as per the dose and schedule specified in the arm.

Drug: Nivolumab
Nivolumab will be administered as per the dose and schedule specified in the arm.
Other Name: Opdivo




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]

Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: Up to 8 hrs post-dose ]
  2. Area Under the Curve (AUC) [ Time Frame: Up to 8 hrs post-dose ]
  3. Minimum Plasma Concentration (Cmin) [ Time Frame: Up to 8 weeks ]
  4. Objective Response Rate [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
  5. Duration of Objective Response [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
  6. Time to Objective Response [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
  7. Disease Control Rate [ Time Frame: 16 weeks and 24 weeks ]
  8. Progression Free Survival [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
  9. Time to Progression [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]


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:

  • Histologically confirmed diagnosis of Renal Cell Carcinoma with a documented clear cell component (ccRCC).
  • Currently receiving nivolumab and considered by Investigator to have the potential to derive clinical benefit from continuing treatment with nivolumab.
  • Based on RECIST v1.1 criteria on current nivolumab treatment (prior to initiation of this study), has a best response of confirmed stable disease (SD) or confirmed progressive disease (PD). Confirmed SD or confirmed PD refers to a response that is confirmed by a second scan which is at least 4 weeks apart from the previous scan.
  • At least one extra-renal measurable target lesion meeting the criteria of RECIST version 1.1.
  • Agree to use contraception from screening, through the study, and for at least 5 months after the last dose of nivolumab as follows: for women of childbearing potential agree to use highly-effective contraceptive methods; for males, agree to use a condom with sexual partner.

Exclusion Criteria:

  • Pregnant or nursing.
  • Life expectancy of less than 3 months.
  • Performance status greater than or equal to (≥) 2 (Eastern Cooperative Oncology Group [ECOG] criteria).
  • New York Heart Association (NYHA) Class III or IV, uncontrolled hypertension, or clinically significant arrhythmia.
  • Previously received X4P-001.
  • Has a second malignancy. Except: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type.
  • Has active central nervous system (CNS) metastases (including evidence of cerebral edema by Magnetic Resonance Imaging [MRI], or progression from prior imaging study, or any requirement for steroids, or clinical symptoms of/from CNS metastases) within 28 days prior to study treatment. Subjects with known CNS metastases must have a baseline MRI scan within 28 days of study treatment.
  • Ongoing clinical adverse events National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade greater than (>) 2 resulting from prior cancer therapies.
  • Known history of Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS); or positive test for hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg).
  • History of clinically significant or uncontrolled cardiac, hepatic, or pulmonary disease.
  • Has had within the past 6 months the occurrence of one or more of the following events: myocardial infarction, cerebrovascular accident, deep vein thrombosis, pulmonary embolism, hemorrhage (NCI CTCAE Grade 3 or 4), chronic liver disease (meeting criteria for Child-Pugh Class B or C), or organ transplantation.
  • Inadequate hematologic, hepatic, or renal function.

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): NCT02923531


Locations
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United States, District of Columbia
Washington, District of Columbia, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
Sponsors and Collaborators
X4 Pharmaceuticals
Investigators
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Study Director: Chief Medical Officer X4 Pharmaceuticals, Inc.

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Responsible Party: X4 Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02923531     History of Changes
Other Study ID Numbers: X4P-001-RCCB
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents