Trial record 4 of 4 for:    nilotinib AND GIST | Open Studies

A Global Imatinib and Nilotinib Pregnancy Exposure Registry

This study is currently recruiting participants.
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01289054
First received: January 31, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

This is a voluntary, international, primarily prospective, observational, exposure-registry and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six months prior to pregnancy.


Condition Intervention
All Indications for Glivec/Gleevec and Tasigna
Drug: Tasigna, Gleevec

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Global Imatinib and Nilotinib Pregnancy Exposure Registry A Post-Authorisation Safety Study (PASS)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects [ Time Frame: During pregnancy or within 6 months prior to conception ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess impact on maternal CML disease when treatment is interrupted [ Time Frame: During pregnancy or within 6 months prior to conception ] [ Designated as safety issue: Yes ]
  • Assess post 12 month post-delivery data on maternal and infant status [ Time Frame: 12 months after birth ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: April 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort 1 - Pregnancy/Fetal Exposure Drug: Tasigna, Gleevec
Other Name: AMN107, STI571
Cohort 2 - Interrupted TKI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women exposed to any dose of Gleevec/Glivec or Tasigna during pregnancy or within 6 months prior to conception

Criteria

Inclusion Criteria:

  • Provide sufficient evidence to confirm that exposure occurred during pregnancy or within 6 months prior to exposure.
  • Be at least 18 years of age
  • Reside in a country supported by the Registry

Exclusion Criteria:

  • Cases that do not meet the eligibility criteria are deemed ineligible, including paternal exposures

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289054

Contacts
Contact: Novartis Pharmaceuticals 800-340-6843

Locations
United States, North Carolina
Kendle, a subsidiary of INC Research, LLC Recruiting
Wilmington, North Carolina, United States, 28405
Contact: Susan Goodlow    877-513-6684      
Denmark
Novartis Investiative Site Recruiting
Copenhagen, Denmark
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01289054     History of Changes
Other Study ID Numbers: CSTI571A2403
Study First Received: January 31, 2011
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Denmark: The Danish National Committee on Biomedical Research Ethics
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Novartis:
GIST
Tasigna
Female
Pregnancy
Hematologic Pregnancy
Complications
Registry
Pregnant Registry
CML
Gleevec
Glivec
Pregnancy Exposure

Additional relevant MeSH terms:
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014