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Trial record 1 of 1 for:    NCT02765165
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Phase 1/2 Study of USL311 Alone and in Combination With Lomustine in Subjects With Advanced Solid Tumors and Relapsed/Recurrent Glioblastoma Multiforme (GBM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Upsher-Smith Laboratories
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT02765165
First received: April 19, 2016
Last updated: February 2, 2017
Last verified: February 2017
  Purpose
This is a multicenter, open-label, Phase 1/2, dose-escalation and dose expansion study of a CXCR4 inhibitor, USL311, alone and in combination with lomustine in subjects with advanced solid tumors (Phase 1) and subjects with relapsed/recurrent GBM (Phase 2). The study is designed to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of USL311 alone and in combination with lomustine.

Condition Intervention Phase
Solid Tumors (Phase 1)
Relapsed/Recurrent GBM (Phase 2)
Drug: USL311
Drug: Lomustine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1/2 Dose-escalation of USL311 as Single Agent and in Combination With Lomustine (CCNU) in Subjects With Advanced Solid Tumors, With Subsequent Single Agent and Combination Phase 2 Cohorts for Subjects With Relapsed/Recurrent Glioblastoma Multiforme (GBM)

Resource links provided by NLM:


Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • Phase 1: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) [ Time Frame: Approximately 26 weeks ]
    USL311 as a single agent in subjects with advanced solid tumors and USL311 in combination with lomustine in subjects with advanced solid tumors

  • Phase 2: Percentage progression free survival (PFS) at 6 months (PFS-6m) [ Time Frame: Approximately 52 weeks ]
    USL311 as a single agent in subjects with relapsed/recurrent GBM and USL311 in combination with lomustine in subjects with relapsed/recurrent GBM


Secondary Outcome Measures:
  • Phase 1 and Phase 2: Treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Approximately 26 or 52 weeks ]
    USL311 as a single agent and in combination with lomustine

  • Phase 1 and Phase 2: Overall survival (OS) [ Time Frame: Approximately 26 or 52 weeks ]
    USL311 as a single agent and in combination with lomustine

  • Phase 1 and Phase 2: Progression free survival (PFS) [ Time Frame: Approximately 26 or 52 weeks ]
    USL311 as a single agent and in combination with lomustine

  • Phase 1 and Phase 2: Objective response rate (ORR%) [ Time Frame: Approximately 26 or 52 weeks ]
    USL311 as a single agent and in combination with lomustine

  • Phase 1 and Phase 2: Peak concentration (Cmax) [ Time Frame: Approximately 26 or 52 weeks ]
    USL311 in plasma and whole blood and lomustine in plasma

  • Phase 1 and Phase 2: Time to peak concentration (Tmax) [ Time Frame: Approximately 26 or 52 weeks ]
    USL311 in plasma and whole blood and lomustine in plasma

  • Phase 1 and Phase 2: Area under the concentration vs time curve (AUC) [ Time Frame: Approximately 26 or 52 weeks ]
    USL311 in plasma and whole blood and lomustine in plasma


Estimated Enrollment: 120
Study Start Date: April 2016
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose-Escalation USL311 Drug: USL311
Administered once weekly in a 21-day cycle
Experimental: Dose-Escalation USL311 plus lomustine Drug: USL311
Administered once weekly in a 42-day cycle
Drug: Lomustine
Administered once every 6 weeks in a 42-day cycle
Experimental: Dose-Expansion USL311 Drug: USL311
Administered once weekly in a 21-day cycle
Experimental: Dose-Expansion USL311 plus lomustine Drug: USL311
Administered once weekly in a 42-day cycle
Drug: Lomustine
Administered once every 6 weeks in a 42-day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All Subjects:

  1. Provide signed and dated informed consent prior to study-specific screening procedures
  2. ≥ 18 years old
  3. Karnofsky performance status (KPS) ≥ 70
  4. Must have adequate bone marrow and renal/hepatic function within protocol specified limits
  5. Disease-free period of > 2 years from any other previous malignancies, excluding curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. Subjects with prostate cancer Stage 1 that do not require treatment may also be included
  6. Women and men must use protocol approved methods of contraception
  7. Must be able and willing to comply with the study visit schedule and study procedures
  8. Must have available archived tumor tissue and willing and able to provide consent for study access to such tissue

    For Phase 1 Subjects Only:

  9. Histologically or cytologically documented diagnosis of solid tumor for which no standard therapy is recognized or have failed or intolerant to the standard-of-care treatment
  10. Inoperable metastatic or locally advanced, unresectable disease
  11. Subjects may have either evaluable or measurable disease
  12. Subjects with treated (surgically excised or irradiated) and stable brain metastases are eligible as long as the subject has adequately recovered from treatment and the treatment was ≥ 28 days prior to initiation of study drug(s) and baseline brain computed tomography (CT) with contrast or magnetic resonance imaging (MRI) ≤ 14 days of initiation of study drug is negative for new brain metastases

    For Phase 2 Subjects Only:

  13. Histologically confirmed diagnosis of GBM
  14. Subjects must have documented recurrence after first-line treatment
  15. Prior first-line treatment must have included radiation and temozolomide
  16. Subject is suitable for re-resection, per Investigator discretion, as a component of their clinical care
  17. No more than one prior resection (Note: biopsy does not count as prior resection)

Exclusion Criteria:

All Subjects

  1. Subjects who have had recent systemic anticancer therapies, interventional device treatment and/or radiotherapy either within 14 days prior to first dose of study drug(s) or have not recovered (to grade ≤ 1) from all clinically significant toxicities related to prior therapies
  2. Subjects who have had any major surgery (not including re-resection surgery required in Phase 2) within 28 days prior to first dose of study drug(s), or minor surgery within 14 days prior to first day of study drug(s)
  3. Subjects taking any protocol prohibited medications within 14 days prior to initiating study drug(s) treatment
  4. Subjects who have been treated with an investigational agent or investigational interventional device within 21 days prior to the first dose of study drug(s)
  5. History of significant cardiac disease
  6. Pregnant or breastfeeding
  7. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation

    For Phase 1 Subjects Only:

  8. Subjects with lymphoma as primary cancer

    For Phase 2 Subjects Only:

  9. Subjects unable or unwilling to consent to the provision of resected tissue after surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02765165

Contacts
Contact: Cindy Moe 1-800-654-2299 cynthia.moe@upsher-smith.com

Locations
United States, Oklahoma
University of Oklahoma Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States
United States, Texas
University of Texas/MD Anderson Cancer Center Recruiting
Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START) Recruiting
San Antonio, Texas, United States
Spain
South Texas Accelerated Research Therapeutics (START) - CIOCC Recruiting
Madrid, Spain
South Texas Accelerated Research Therapeutics (START) FJD Recruiting
Madrid, Spain
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT02765165     History of Changes
Other Study ID Numbers: P311-201 
Study First Received: April 19, 2016
Last Updated: February 2, 2017

Keywords provided by Upsher-Smith Laboratories:
Phase 1
Phase 2
Glioblastoma Multiforme
Glioblastoma
GBM
Brain Tumor
Brain Cancer
Tumor
Solid Tumor
Tumour
Lomustine
CCNU
CXCR4
Phase 1 Clinical Trial
Phase 2 Clinical Trial

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Lomustine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 20, 2017