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Protocol # 20-211

Status

Active, not recruiting

Description

The study consists of 2 parts. Part 1 is dose escalation and will first administer SY-5609 alone to participants with select advanced solid tumors and then in combination with fulvestrant to participants with HR positive, HER2-negative breast cancer. Part 2 is a dose expansion and will first administer SY-5609 in combination with gemcitabine and then SY-5609 in combination with gemcitabine and nab-paclitaxel in participants with pancreatic ductal adenocarcinoma (PDAC) .

Condition

  • Advanced Solid Tumor
  • Breast Cancer
  • Small-cell Lung Cancer
  • Pancreatic Cancer

Interventions

  • SY-5609
  • Fulvestrant
  • Gemcitabine
  • Nab-paclitaxel

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Groups 1 and 2: Dose-Limiting Toxicity of SY-5609
  • Groups 1 and 2: Number of Participants With Treatment Emergent Adverse Events
  • Groups 3 and 4 (Safety Lead-ins): Number of Participants With Dose-Limiting Toxicity
  • Groups 3 and 4 (Safety Lead-ins): Number of Participants With TEAEs
  • Groups 3 and 4 (Expansions): Progression Free Survival

Secondary Outcome:

  • Groups 1 and 2: Area Under The Concentration Versus Time Curve of SY-6509
  • Groups 1 and 2: Apparent Clearance of SY-5609
  • Groups 1 and 2: Apparent Volume of Distribution of SY-5609
  • Groups 1 and 2: Elimination Half-Life of SY-5609
  • Groups 1 and 2: Maximum Plasma Concentration (Cmax) of SY-5609
  • Groups 1 and 2: Time of Maximum Plasma Concentration (Tmax) of SY-5609
  • Groups 1 and 2: Minimum or Trough Plasma Concentration (Cmin) of SY-5609
  • Groups 1 and 2: Time of Minimum or Trough Plasma Concentration (Tmin) of SY-5609
  • Groups 3 and 4 (Safety Lead-ins): Progression Free Survival
  • Groups 3 and 4 (Safety Lead-ins): Objective Response Rate (ORR)
  • Groups 3 and 4 (Safety Lead-ins): Complete Response/Remission (CR) Rate
  • Groups 3 and 4 (Safety Lead-ins): Disease Control Rate
  • Groups 3 and 4 (Safety Lead-ins): Time to Response
  • Groups 3 and 4 (Safety Lead-ins): Duration of Response
  • Groups 3 and 4 (Expansions): Objective Response Rate
  • Groups 3 and 4 (Expansions): Complete Response Rate
  • Groups 3 and 4 (Expansions): Disease Control Rate
  • Groups 3 and 4 (Expansions): Time to Response
  • Groups 3 and 4 (Expansions): Duration of Response

Enrollment

160

Study Start Date

January 23, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Syros Pharmaceuticals

Source

Syros Pharmaceuticals

Official title

A Phase 1 Study of SY 5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors

Clinicaltrials.gov Identifier

NCT04247126

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.