A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Phase 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Measured over: From the signing of the informed consent form (ICF) through 90 days after the last dose (Up to approximately 16 months)

• Phase 1: Number of Participants with TEAEs Based on Severity

  Measured over: From the signing of the ICF through 90 days after the last dose (Up to approximately 16 months)

• Phase 1: Number of Participants with Dose- limiting Toxicities (DLTs)

  Measured over: Up to Cycle 1 (21 days)

• Phase 1: Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)

  Measured over: From the signing of the ICF through 90 days after the last dose (Up to approximately 16 months)

• Phase 1: Number of Participants with Treatment-emergent Adverse Events Leading to Dose Modifications and Treatment Discontinuations

  Measured over: From the signing of the ICF through 90 days after the last dose (Up to approximately 16 months)

• Phase 1b Backfill and Phase 2 Dose Expansion and Optimization: Overall Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  Measured over: Up to 24 months

• Phase 1b Backfill and Phase 2 Dose Expansion and Optimization: Disease Control Rate (DCR)

  Measured over: Up to 24 months

• Phase 1b Backfill and Phase 2 Dose Expansion and Optimization: Duration of Response (DOR)

  Measured over: Up to 24 months

Changes Tremor has spotted