deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT01267253

Brivanib Alaninate in Treating Patients With Persistent or Recurrent Cervical Cancer

A Phase II Evaluation of Brivanib (BMS582664) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix (BMS Study CA182-048)

Sponsor: Gynecologic Oncology Group

Updated 11 times since 2017 Last updated: Mar 8, 2019 Started: Apr 4, 2011 Primary completion: Feb 28, 2014 Completion: Feb 28, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01267253, this PHASE2 trial focuses on Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma and remains completed. Sponsored by Gynecologic Oncology Group, it has been updated 11 times since 2011, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

PRIMARY OBJECTIVES: I. To estimate the proportion of patients with persistent or recurrent cervical cancer, who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with brivanib (brivanib alaninate). II. To determine the nature and degree of toxicity of brivanib 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 cervical cancer treated with brivanib. TERTIARY OBJECTIVES: I. To obtain the serum expression levels of surrogate markers of brivanib effects including angiogenic factors (vascular endothelial growth factor \[VEGF\] and basic fibroblast growth factor \[bFGF\]) and markers of endothelial damage (E-selectin, vascular cell adhesion molecule 1 \[VCAM-1\], and (intercellular adhesion molecule 1 \[ICAM-1\]). (exploratory) II. To determine whether these marker expression levels alone or in combination are associated with response, PFS, or overall survival. (exploratory) OUTLINE: Patients receive brivanib alaninate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

PRIMARY OBJECTIVES:

I. To estimate the proportion of patients with persistent or recurrent cervical cancer, who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with brivanib (brivanib alaninate).

II. To determine the nature and degree of toxicity of brivanib 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 cervical cancer treated with brivanib.

TERTIARY OBJECTIVES:

I. To obtain the serum expression levels of surrogate markers of brivanib effects including angiogenic factors (vascular endothelial growth factor \[VEGF\] and basic fibroblast growth factor \[bFGF\]) and markers of endothelial damage (E-selectin, vascular cell adhesion molecule 1 \[VCAM-1\], and (intercellular adhesion molecule 1 \[ICAM-1\]). (exploratory) II. To determine whether these marker expression levels alone or in combination are associated with response, PFS, or overall survival. (exploratory)

OUTLINE:

Patients receive brivanib alaninate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~May 2017 · 3 months · monthly snapshotCompleted~May 2017 – ~Oct 2017 · 5 months · monthly snapshotCompleted~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshotActive Not Recruiting~Apr 2019 – ~Jan 2021 · 21 months · monthly snapshotCompleted~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshotCompleted~Feb 2021 – ~Jul 2024 · 41 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Feb 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jan 2021 — Feb 2021 [monthly]

    Completed PHASE2

Show 6 earlier versions
  1. Apr 2019 — Jan 2021 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  2. Jun 2018 — Apr 2019 [monthly]

    Active Not Recruiting PHASE2

  3. Oct 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

    Status: CompletedActive Not Recruiting

  4. May 2017 — Oct 2017 [monthly]

    Completed PHASE2

  5. Feb 2017 — May 2017 [monthly]

    Completed PHASE2

  6. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Apr 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Gynecologic Oncology Group
  • National Cancer Institute (NCI)
Data source: GOG Foundation

For direct contact, visit the study record on ClinicalTrials.gov .