NCT01485874

Brief Summary

The purpose of this trial is to determine whether BIBF 1120 can be safely combined with pegylated liposomal doxorubicin (phase I), and to determine the clinical activity of the combination in patients with platinum-resistant ovarian cancer (phase II).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 ovarian-cancer

Timeline
Completed

Started Nov 2011

Typical duration for phase_1 ovarian-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

4.1 years

First QC Date

December 2, 2011

Last Update Submit

February 14, 2022

Conditions

Ovarian Cancer

Keywords

BIBF 1120

Outcome Measures

Primary Outcomes (2)

  • Phase I: Safety and Toxicity of Treatment Regimen

    To find the maximum tolerated dose (MTD) to be used during the Phase II trial and evaluate the safety and toxicity of the combination BIBF 1120 plus PLD in patients with recurrent or resistant epithelial ovarian or endometrial cancer.

    3 months

  • Phase II: Objective Response Rate

    To assess response rate (objective response) in patients with recurrent or resistant epithelial ovarian cancer treated with BIBF 1120 plus PLD.

    12 months

Secondary Outcomes (2)

  • Phase I and II: Progression-Free Survival

    12 months

  • Phase I and II: Clinical Benefit

    12 months

Study Arms (1)

Doxil + BIBF 1120

EXPERIMENTAL
Drug: Doxil (Pegylated Liposomal Doxorubicin)Drug: BIBF 1120

Interventions

Doxil (Pegylated Liposomal Doxorubicin)DRUG

Phases I and II: 40 mg/m2 IV over 60 min (+/- 15 min) on day 1 of 28-day cycle

Doxil + BIBF 1120
BIBF 1120DRUG

Phase I: Escalating cohorts days -2 through +2, orally 100mg bid, 150mg bid, 200mg bid Phase II: MTD orally, bid, day 2 of 28-day cycle

Doxil + BIBF 1120

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Platinum-resistant (recurrence within 6 months of a platinum-containing regimen) or platinum refractory (progression while on platinum) disease.
  • Measurable disease as defined by RECIST v1.1 criteria on screening testing
  • Be ≥18 years of age at the time of providing written informed consent for participation.
  • Give written, informed consent for participation in the protocol.
  • Must consent to correlative blood sample collections.
  • Be at least 4 weeks from last treatment to allow recovery from prior toxicity to a Grade 1 or less.
  • The following exceptions are allowed: hormonal therapy - 1 week wash-out; radiation therapy - 3 week wash-out; weekly chemotherapy - 3 week wash-out
  • Patients coming off experimental therapy with biological agents with long half lives (e.g., antibodies) not expected to cause myelotoxicity should be off treatment for at least 4 weeks.
  • Negative serum pregnancy test within 14 days prior to the study entry and be practicing an effective form of contraception if hysterectomy and/or oophorectomy was not part of the prior treatment

You may not qualify if:

  • Prior therapy with pegylated liposomal doxorubicin or doxorubicin.
  • Prior therapy with BIBF 1120.
  • Prior anti-angiogenic therapy with tyrosine kinase inhibitors (e.g. sorafenib, sunitinib, others). Note: Prior therapy with bevacizumab is allowed, provided that at least 3 months have elapsed since the last dose of bevacizumab.
  • Grade 2 or greater neuropathy, at time of registration.
  • Active cancer within the last 5 years, with the exception of superficial skin cancer (basal cell or squamous cell skin carcinoma), carcinoma in situ of the cervix, Stage I endometrial cancer with less than 50% invasion of the myometrium, or other adequately treated Stage I or II cancer in complete remission.
  • Presence of active infection requiring antibiotic treatment, at time of registration.
  • Presence of uncontrolled serious medical condition or psychiatric illness as determined by the treating physician, at time of registration.
  • Known history of immune deficiency and be receiving combination anti-retroviral therapy
  • Known or clinically manifest brain metastases, as progressive neurologic dysfunction may develop, that would confound the evaluation of neurologic and other adverse events.
  • Presence of gastrointestinal disorders or abnormalities that would influence the absorption of the study drug.
  • Presence of uncontrolled hypertension, arrhythmia, congestive heart failure or angina, at time of registration. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.
  • Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infection disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
  • Major injuries within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period.
  • History of clinically significant hemorrhagic or thromboembolic event in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

  • Maria Creselda deLeon, Alesha Arnold, Emma Caroline Rossi, Jamie Case, Cynthia Johnson, Yan Zeng, Daniela Matei. Phase I trial of pegylated liposomal doxorubicin in combination with BIBF 1120 (nintedanib) in platinum-resistant ovarian cancer: Hoosier Oncology Group GYN10-149. J Clin Oncol 32:5s, 2014 (suppl; abstr 5541^)

    BACKGROUND

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

liposomal doxorubicinnintedanib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Daniela Matei, M.D.

    Hoosier Cancer Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 6, 2011

Study Start

November 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 15, 2022

Record last verified: 2022-02

Locations

US(2)