Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies the side effects and how well nintedanib works in treating patients with endometrial cancer that has come back. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To estimate the proportion of patients with persistent or recurrent endometrial cancer, who survive progression-free without going on a subsequent therapy against the disease for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with BIBF 1120 (nintedanib).

II. To determine the nature and degree of toxicity of BIBF 1120 in this cohort of patients.

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with BIBF 1120.

OUTLINE:

Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01225887
Study type Interventional
Source Gynecologic Oncology Group
Contact
Status Completed
Phase Phase 2
Start date October 2011
Completion date January 2016

See also
  Status Clinical Trial Phase
Completed NCT01935973 - Trametinib With or Without GSK2141795 in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 1
Active, not recruiting NCT03660826 - Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone Phase 2
Active, not recruiting NCT04106414 - Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment Phase 2
Completed NCT01642082 - Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT01208467 - Prognostic Biomarkers in Patients With Endometrial Cancer N/A
Completed NCT01011933 - Selumetinib in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT00025467 - Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT01440998 - Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer Phase 1
Completed NCT00006089 - Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Phase 2
Active, not recruiting NCT00977574 - Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Phase 2
Recruiting NCT05001282 - A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±) Phase 1/Phase 2
Completed NCT01968317 - Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma Phase 2
Completed NCT01005329 - Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer Phase 2
Active, not recruiting NCT02208375 - mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Phase 1/Phase 2
Completed NCT03716414 - Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
Withdrawn NCT03836157 - Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer Phase 2
Not yet recruiting NCT06399757 - A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT00095979 - Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT00072176 - Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer Phase 2
Active, not recruiting NCT03460483 - Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care N/A