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Evaluation of TRANSKRIP ® Plus Chemotherapy in Recurrent-Persistent Cervical Cancer

NCT02446652 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-05-29

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety the combination of TRANSKRIP ® vs placebo plus Carboplatin/Paclitaxel as first line treatment in patients with recurrent-persistent cervical cancer.

Conditions

Interventions

DRUG

Hydralazine/Magnesium

(Hydralazine: 1 oral tablet every 24 hours, 182 mg for rapid acetylators, and 83 mg for low acetylators and Magnesium valproate: orally 30 mg/K weight every 8 hours) starting 1 week prior the first day of the QT

DRUG

Placebo

Placebo (orally) starting 1 week before the first day of the QT

DRUG

Carboplatin

5 AUC 1 hour/day 1 for every 21 days for 6 cycles

DRUG

Paclitaxel

175mg/m2/SC 3hour/day 1 for every 21 days for 6 cycles.

Sponsors & Collaborators

  • Psicofarma S.A. de C.V.

    collaborator OTHER

  • National Institute of Cancerología

    lead OTHER_GOV

Principal Investigators

  • Cetina Lucely, MSc · Instituto Nacional de Cancerologia de Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2018-07-31
Completion
2018-08-31

Countries

  • Mexico

Study Locations

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Entities

Drugs
Diseases

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 NCT02446652 on ClinicalTrials.gov