An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring

Study Identifier:
PLATFORMPACAN1001
CT.gov Identifier:
NCT06788509
EudraCT Identifier:
202452000000
EU Trial (CTIS) Number:
2024-515457-21-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mCRPC).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Leukemia
  • Myeloid
  • Lymphocytic
  • Lymphoma
  • Myelodysplastic Syndrome
  • Neoplasms
  • Solid Tumor
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Have participated in a parent study, with a linked intervention specific appendix (ISA) within this platform study, in which they initially received study treatment(s) prior to rolling over to this platform study
    • * Satisfy all ISA specific inclusion criteria
    • * Sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the platform study with details per the relevant ISA
    • * Be willing and able to adhere to the lifestyle restrictions specified in the relevant ISA
    Exclusion criteria
    • * Have any condition or situation which, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
    • * Have unacceptable toxicities or overt disease progression observed at time of rollover to the respective ISA
    • * Meets any exclusion criteria within the pertinent ISA

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruitment on Hold
    Condition(s) Treated at Site
    Leukemia
    Myeloid
    Lymphocytic
    Lymphoma
    Myelodysplastic Syndrome
    Neoplasms
    Solid Tumor
    Prostate