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Paclitaxel and TAK-228 in Urothelial Carcinoma

NCT03745911 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-11-19

No results posted yet for this study

Summary

Phase II Multicentre, single arm, open label study of Paclitaxel and TAK-228 in metastatic urothelial carcinoma (UC) and the impact of PI3K-mTOR pathway genomic alterations

Conditions

  • Metastatic Urothelial Cancer

Interventions

COMBINATION_PRODUCT

Paclitaxel and TAK-228

Treatment with TAK-228 oral (D2, 3 and 4 of each week) and paclitaxel (D1 of each week) on Days 1, 8 and 15 for each 28-days cycle until disease progression or unacceptable toxicity. If paclitaxel is stopped, TAK-228 may be continued

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Pivotal S.L.

    collaborator INDUSTRY

  • Associació per a la Recerca Oncologica, Spain

    lead OTHER

Principal Investigators

  • Joaquín Bellmunt, MD/PhD · Hospital del Mar

  • Alejo Rodríguez-Vida, MD/PhD · Hospital del Mar

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-04
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745911 on ClinicalTrials.gov