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MOLECULARY TARGETED: PIK3CA Multiple Mutant Tumors (TAPISTRY ARM H)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort H: Inavolisib (GDC-0077) in patients with PIK3CA multiple mutant-positive tumors

Title
ROCHE BO41932: TAPISTRY ARM H
Study Title

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort H: Inavolisib (GDC-0077) in patients with PIK3CA multiple mutant-positive tumors

Site Link
Malignancy
Solid Tumors
Stage
Disease Setting
metastatic or advanced
Line Of Therapy
any
Investigational Agent
Inavolisib (GDC-0077)
Drug Class
PI3K-p110α (PIK3CA) inhibitor
PI
Daniel Vaena, MD
Sponsor
Hoffmann-La Roche
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details

Inclusion Criteria:

  • Patients with at metastatic or advanced solid tumors with at least 2 PIK3CA mutations
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
Objective

Overall Response Rate

Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X