Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON47685
NL-OMON47685
Completed
Phase 2

A phase II study exploring the safety and efficacy of nintedanib (BIBF1120) as second line therapy for patients with eitherc differentiated and medullary thyroid carcinoma progressing after first line therapy. - EORTC protocol 1209-EnTF

European Organisation for Research in Treatment of Cancer (EORTC)0 sites15 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionsthyroid cancerthyroid carcinoma10043739

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
thyroid cancer
Sponsor
European Organisation for Research in Treatment of Cancer (EORTC)
Enrollment
15
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
European Organisation for Research in Treatment of Cancer (EORTC)

Eligibility Criteria

Inclusion Criteria

  • •\* Histologically confirmed differentiated or medullary thyroid cancer by
  • •local pathologist.
  • •\* Available tumor tissue at the time of initial diagnosis for histology
  • •\* Locally advanced or metastatic disease deemed incurable by surgery,
  • •radiotherapy and/or radioactive iodine (RAI).
  • •\* Patients must have measurable lesion with documented progression
  • •during the 12 months prior to randomization.
  • •\* Patients must have received one or 2 prior line of treatment (but no more than two) and must be off treatment for at least 4 weeks prior to randomization. Patients with an MTC must have received one or 2 prior line of treatment (but no more than two) and must be off treatment for at least 4 weeks prior to randomization. If it is available and reimbursed in the respective country one of the prior lines of treatment needs to be with Vandetanib as long as there is no contraindication or the patient refuses the treatment with Vandetanib.
  • •\* Age \*18 years.
  • •\* Performance status (PS) 0\-1 (WHO, Appendix C).

Exclusion Criteria

  • •\* Current symptomatic brain metastases or if previously present, must
  • •have been treated at least two months before randomization.
  • •\* History of other malignancy within the last 5 years, except for
  • •adequately treated carcinoma in situ of the cervix or basal cell or
  • •spinocellular carcinoma of the skin.
  • •\* Ongoing treatment related toxicity due to prior treatment \> grade I
  • •(except alopecia).
  • •\* History of significant cardiac disease
  • •\* Current uncontrolled hypertension
  • •\* Evidence of active bleeding or bleeding diathesis.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
A phase II study of second line therapy on safety and efficacy of nintedanib for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.Histologically confirmed differentiated or medullary thyroid cancer by local pathologist.MedDRA version: 17.0Level: PTClassification code 10027105Term: Medullary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10066474Term: Thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10033701Term: Papillary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2012-004295-19-FREuropean Organisation for Research and Treatment of Cancer. EORTC102
Active, not recruiting
Phase 1
A phase II study of second line therapy on safety and efficacy of nintedanib for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.
EUCTR2012-004295-19-BEEuropean Organisation for Research and Treatment of Cancer (EORTC)102
Active, not recruiting
Phase 1
A phase II study of second line therapy on safety and efficacy of nintedanib for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.
EUCTR2012-004295-19-DKEuropean Organisation for Research and Treatment of Cancer (EORTC)142
Active, not recruiting
Phase 1
A phase II study of second line therapy on safety and efficacy of nintedanib for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.Histologically confirmed differentiated or medullary thyroid cancer by local pathologist.MedDRA version: 21.1Level: PTClassification code 10027105Term: Medullary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10066474Term: Thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10033701Term: Papillary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2012-004295-19-GBEuropean Organisation for Research and Treatment of Cancer (EORTC)102
Active, not recruiting
Phase 1
A phase II study of second line therapy on safety and efficacy of nintedanib for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.
EUCTR2012-004295-19-ESEuropean Organisation for Research and Treatment of Cancer. EORTC102