Oral repotrectinib (TPX-0005) for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lymphoma+3 MoreOral repotrectinib (TPX-0005) - Drug
Eligibility
No minimum age - 25
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for safety and effectiveness in treating pediatric and young adult cancer patients.

Eligible Conditions
  • Locally Advanced Solid Tumors
  • Solid Metastatic Tumor
  • Lymphoma
  • Primary Central Nervous System Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: Approximately three years

Approximately three years
Central Nervous System Progression-Free Survival (CNS-PFS) (Phase 2)
Clinical Benefit Rate (CBR) (Phase 1 and Phase 2)
Duration of response (DOR) (Phase 1 and Phase 2)
Intracranial objective response rate (IC-ORR) (Phase 1 and Phase 2)
Overall Response Rate (ORR) (Phase 1)
Overall survival (OS) (Phase 2)
Progression-free survival (PFS) (Phase 2)
Time to response (TTR) (Phase 1 and Phase 2)
Day 28
Area under the concentration versus time curve of repotrectinib in plasma (AUC)
Maximum concentration of repotrectinib in plasma (Cmax)
Two to three years after first dose of repotrectinib
Overall Response Rate (ORR) (Phase 2)
Day 28
Dose limiting toxicities (DLTs) (Phase 1)
Day 28
Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Repotrectinib (TPX-0005)
1 of 1

Experimental Treatment

75 Total Participants · 1 Treatment Group

Primary Treatment: Oral repotrectinib (TPX-0005) · No Placebo Group · Phase 1 & 2

Repotrectinib (TPX-0005)
Drug
Experimental Group · 1 Intervention: Oral repotrectinib (TPX-0005) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately three years

Who is running the clinical trial?

Turning Point Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
1,236 Total Patients Enrolled
Turning Point Therapeutics, MDStudy DirectorTurning Point Therapeutics
3 Previous Clinical Trials
482 Total Patients Enrolled
Zachary Zimmerman, M.D.Study DirectorTurning Point Therapeutics

Eligibility Criteria

Age No minimum age - 25 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be tested for ALK, ROS1, or NTRK1-3 alteration (point mutation, fusion, amplification) in a CLIA laboratory in the US or equivalently accredited diagnostic lab outside the US.
Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 14 days prior to enrollment.
Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to NCI CTCAE Version 4.03 Grade less than or equal to 1.
You must have measurable disease by RECIST v1.1 or RANO criteria at time of enrollment.
Subjects must have a Lansky or Karnofsky score of at least 50.
You have hematologic, renal and hepatic function.