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A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
Overall Recruitment Status: Active, currently enrolling
 
Official Title
MyTACTIC: An Open-Label Phase II Study Evaluating Targeted Therapies in Patients Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
 
Region Sponsors
Northwest
Genentech
 
Acronym KP IRB No.
(MyTACTIC) 1724381
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
(Adult, Older Adult) Male and Female with Advanced Unresectable or Metastatic Solid Malignancy
 
Purpose
This is a Phase II, multicenter, non-randomized, open-label, multi-arm study designed to evaluate the safety and efficacy of targeted therapies as single agents or in rational, specified combinations in participants with advanced unresectable or metastatic solid tumors determined to harbor specific biomarkers. Patients will be enrolled based on local testing performed at a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory. The multi-arm structure of the MyTACTIC study allows patients with solid tumors to be treated with a drug or drug regimen tailored to their biomarker identified at screening.
 
Detailed Description
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a Clinical Laboratory Improvement
  • Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory and availability of a full report of the testing results. This may be from a tissue or blood sample
  • Evaluable or measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Life expectancy >8 weeks
  • Adequate hematologic and end-organ function, as defined in the protocol, obtained within 14 days prior to initiation of study treatment
  • Agrees to take measures to prevent pregnancy in the patient or partner
  • In addition to the general inclusion criteria above, there are treatment-specific inclusion criteria that apply for each respective treatment arm (as detailed in the protocol)
 
Exclusion Criteria
  • Current participation or enrollment in another therapeutic clinical trial
  • Symptomatic or actively progressing CNS metastases (asymptomatic patients with treated or untreated CNS metastases may be eligible, provided all protocol-defined criteria are met)
  • History of leptomeningeal disease, unless noted otherwise for a specific treatment arm of the study
  • Wide field radiotherapy within 14 days prior to start of study treatment Stereotactic radiosurgery within 7 days prior to start of study treatment
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact patient safety
  • Receipt of any anticancer drug/biologic or investigational treatment 21 days prior to Cycle 1, Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1, Day 1 (androgen blockage may be continued for male patients with prostate cancer)
  • Known HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV) infection with status outside of study-allowed criteria
  • Please contact study team for additional exclusion criteria

 
Keywords and/or Specific Medical Conditions
  • Ado-trastuzumab emtansine
  • Mitosis Modulators
  • Antimitotic Agents
  • Molecular Mechanisms of Pharmacological Action
  • Antineoplastic Agents
  • Neoplasms
  • Antineoplastic Agents, Immunological
  • Paclitaxel
  • Antineoplastic Agents, Phytogenic
  • Pertuzumab
  • Atezolizumab
  • Protein Kinase Inhibitors
  • Entrectinib
  • Trastuzumab
  • Enzyme Inhibitors
  • Tubulin Modulators
  • Maytansine
  • Oncology (Adult)
 
KP Clinical Facility
  • Central Interstate Medical Office
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Sandeep Mashru, MD
Contact Information:
- Susan J Granat
-Susan.J.Granat@kpchr.org
-Central Interstate Medical Office


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