Effect of Sapanisertib (MLN0128) on the QTc Interval in Participants With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: Sapanisertib
Intervention description: Sapanisertib capsules.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to characterize the effect of a single dose of 40 mg
      sapanisertib (MLN0128) on the electrocardiographic QT/QTc interval in participants with
      advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria

          -  Men or women participants 18 years or older.

          -  Must have a radiographically or clinically evaluable solid tumor Eastern Cooperative
             Oncology Group (ECOG) performance status of 0 or 1.

          -  Female participants who are postmenopausal for at least 1 year before the screening
             visit, OR are surgically sterile, OR if they are of childbearing potential, agree to
             practice 2 effective methods of contraception, at the same time, from the time of
             signing the informed consent through 3 months after the last dose of study drug, 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.)

          -  Male participants, even if surgically sterilized (i.e., status post vasectomy), who
             agree to practice effective barrier contraception during the entire study treatment
             period and through 3 months after the last dose of study drug, 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 for the female partner] and withdrawal are not acceptable methods of
             contraception.)

          -  Voluntary written consent must be given before performance of any study-related
             procedure not part of standard medical care, with the understanding that consent may
             be withdrawn by the participant at any time without prejudice to future medical care.

          -  Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and
             suitable venous access for the study-required blood sampling.

        Exclusion Criteria

          -  Female participants who are lactating and breastfeeding or have a positive serum
             pregnancy test during the screening period.

          -  Any serious medical or psychiatric illness that could, in the investigator's opinion,
             potentially interfere with the completion of treatment according to this protocol.

          -  Treatment with any investigational products within 14 days before the first dose of
             study drug and systemic anticancer therapy within 28 days before the first dose of
             study drug.

          -  Untreated brain metastasis or history of leptomeningeal disease or spinal cord
             compression.

          -  Tumors with involvement of the mediastinum.

          -  Failure to recover from the reversible effects of prior anticancer therapies with the
             exception of alopecia, and after-effects associated with prior tyrosine kinase
             inhibitor therapy such as hair depigmentation, hypothyroidism, and/or splinter
             hemorrhage.

          -  Systemic corticosteroid (inhalers are allowed) within 7 days before the first dose of
             study drug.

          -  Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI
             disease, or for an unknown or other reason that may alter the absorption of
             Sapanisertib.

          -  Diagnosis of diabetes mellitus; participants with a history of transient glucose
             intolerance due to corticosteroid administration may be enrolled if all other
             inclusion/exclusion criteria are met.

          -  Significant active cardiovascular or pulmonary disease at study entry

          -  History of arrhythmia requiring an implantable cardiac defibrillator

          -  Clinically significant comorbidities such as uncontrolled pulmonary disease, active
             central nervous system disease, active infection, serious infection within 14 days
             before the first dose of study drug, or any other condition that could compromise
             study participation by the participant.