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Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319276
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Christopher Chitambar, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE March 20, 2020
First Posted Date  ICMJE March 24, 2020
Last Update Posted Date March 25, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2020)
Maximum-tolerated dose. [ Time Frame: Each 28-day cohort ]
This will be determined from the incidence of dose limiting toxicities at each dosage.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2020)
  • Progression-free survival [ Time Frame: 6 months ]
    This measure is the number of months participants remain free from evidence of disease. Imaging will be done every eight weeks and reported at six months.
  • Overall survival [ Time Frame: 6 months ]
    Overall survival is determined as the average number of months subjects survived following enrollment.
  • Dose-limiting toxicity [ Time Frame: 28 days for each cohort ]
    Number of participants experiencing a dose limiting toxicity.
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 Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Official Title  ICMJE A Phase 1 Clinical Trial of Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Brief Summary This is a phase 1 investigational study to assess the safety and preliminary efficacy of oral gallium maltolate (GaM) in participants with relapsed glioblastoma (GBM).
Detailed Description This is a prospective, single-center, single-arm, open-label phase 1 study to determine the antineoplastic activity, safety and tolerance of GaM in participants with relapsed, treatment-refractory GBM. Although GaM has been studied in previous phase 1 clinical trials in normal individuals and in participants with a variety of different solid tumors, it has never been evaluated in this population of participants. Dosages in this study have been defined to have limited side effects in other phase 1 trials. The maximum number of participants to enroll in the dose escalation part will not exceed 24. The trial will follow a 3 + 3 phase I dose escalation design.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Drug: Gallium maltolate
    This is a 3+3 design. The doses are as follows level -1: 250 mg daily; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily.
    Other Name: CAS 108560-70-9
  • Drug: Gallium maltolate (recommended phase 2 dose)
    The maximum-tolerated dose (recommended phase 2 dose).
    Other Name: CAS 108560-70-9
Study Arms  ICMJE
  • Experimental: Dose-escalation Phase
    This is a 3 + 3 design. Participants will be entered sequentially. If 0 of 3 participants has a dose-limiting toxicity (DLT), new participants may be entered at the next higher dose level. If 1 of 3 participants has a DLT, up to 3 more participants are to be treated at that same dose level. If 0 of the additional 3 participants at that dose level has a DLT, new participants may be entered at the next higher dose level. If 1 or more of the additional 3 participants experience a DLT, 0 participants are to be started at that dose level and the preceding dose is the maximum-tolerated dose (MTD). If 2 of 3 of the dosed participants has a DLT on the first dose level, the drug will be administered at a lower dose. If 0 of 3 participants has a DLT at the highest dose level, an additional 3 participants will be enrolled to ensure that 6 participants are treated at the MTD. The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a DLT.
    Intervention: Drug: Gallium maltolate
  • Experimental: Dose-expansion Phase
    A minimum of six participants will be enrolled in the dose expansion phase for a total of 12 subjects at the recommended phase 2 dose.
    Intervention: Drug: Gallium maltolate (recommended phase 2 dose)
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Voluntary written consent must be obtained before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  2. All participants must have a prior histological diagnosis of GBM (WHO Grade IV).
  3. Participants have previously undergone standard treatment with radiation and/or chemotherapy and/or surgical resection. These treatments must be completed at least two weeks prior to GaM administration. There is no maximum limit to the amount of chemotherapy or radiation participants have received.
  4. Participants must have measurable disease that can be assessed for response to treatment as defined by the Response Assessment in Neuro-Oncology (RANO) criteria which incorporates MRI assessment and clinical factors.
  5. Male or female subjects ≥18 years to ≤ 75 years.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  7. Participants must have adequate hepatic and renal function based on the following laboratory tests:

    1. Alanine Aminotransferase (ALT) ≤ 2 x upper limit of normal (ULN)
    2. Aspartate Aminotransferase (AST) ≤ 2 x ULN
    3. Alkaline phosphatase ≤ 2 x ULN
    4. Total bilirubin ≤ 2 x ULN
    5. Creatinine < 1.5 mg/dL or Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease Study (MDRD) > 45
  8. Female participants must meet one of the following:

    • Postmenopausal for at least one year before enrollment, OR
    • Surgically sterile (i.e., undergone a hysterectomy or bilateral oophorectomy), OR
    • If participant is of childbearing potential (defined as not satisfying either of the above two criteria), agree to practice two acceptable methods of contraception (combination methods require use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive) from the time of signing of the informed consent form through 21 days after the last dose of study agent, OR
    • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable contraception methods.) 9. Male participants, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
    • Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR
    • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)

Exclusion Criteria:

  1. Presence of other active malignant disease diagnosed within 12 months, with the exception of adequately treated non-melanoma skin cancer, adequately treated melanoma grade 2 or less, or cervical intraepithelial neoplasia. Active malignancy is malignancy receiving treatment.
  2. Prior chemotherapy or radiotherapy within 14 days of study entry.
  3. Known hypersensitivity to or intolerance to gallium-based medications.
  4. Concurrent use of cytotoxic chemotherapy is not permitted.
  5. Unstable or severe concurrent medical conditions such as severe heart (New York Heart Association Class 3 or 4) or known lung (FEV <50%) disease, uncontrolled diabetes mellitus.
  6. Participants who have not completed all standard-of-care treatments including surgical procedures and radiation therapy.
  7. Inability to tolerate an oral medication or keep pills down.
  8. Participants who are pregnant or nursing.
  9. Participants with any condition which, in the investigator's opinion, makes the participant unsuitable for study participation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 414-805-8900 cccto@mcw.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04319276
Other Study ID Numbers  ICMJE IIT-Chitambar-Gallium
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christopher Chitambar, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Chitambar, MD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date March 2020

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