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Ovarian CancerPhase 1NCT01485874

Doxorubicin + BIBF 1120 in Patients for Ovarian Cancer

A Phase 1 study testing Doxil (Pegylated Liposomal Doxorubicin) and BIBF 1120 in people with Ovarian Cancer, run by Hoosier Cancer Research Network at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Doxil (Pegylated Liposomal Doxorubicin) and BIBF 1120
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesUnited States
Study dates
Nov 2011to Dec 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of Wisconsin

    Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: A Phase I-II Clinical Trial of Pegylated Liposomal Doxorubicin (Doxil®) in Combination With BIBF 1120 in Patients With Ovarian Cancer: Hoosier Oncology Group GYN10-149

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).

Read the detailed description

OUTLINE: This is a phase I/II multi-center study.

Phase I:

All patients will receive a fixed dose of pegylated liposomal doxorubicin (Doxil) of 40 mg/m2 administered IV every 28 days. The dose of BIBF 1120 will be escalated in successive cohorts of patients. A maximum of 12 cycles of combined therapy will be administered corresponding to maximum cumulative dose of PLD of 480 mg/m2. Continuation therapy with single agent BIBF 1120 may continue for selected patients.

The escalation phase will follow the standard 3+3 design. Patients will be accrued to each dose level in cohorts of up to 3-6 evaluable patients. Escalation will continue until a DLT is observed, the highest dose level is reached, or medical judgment indicates. An expansion cohort of 3 to 6 patients will be treated at the MTD (or highest dose level if the MTD is not reached), in order to ensure tolerability of the regimen prior to initiating the Phase II component of the study.

Phase II:

Patients will receive a fixed dose of pegylated liposomal doxorubicin (Doxil) of 40 mg/m2 administered IV every 28 days. Patients will be treated at either dose Level +2 or the MTD dose level of BIBF 1120 as defined by the Phase I cohort. Each cycle will be 28 days. Patients will continue treatment with the combination therapy for a total of up to 12 cycles.

ECOG Performance Status 0-1

Life Expectancy: Not specified

Hematopoietic:

  • Absolute neutrophil count ≥ 1500 cells/mm3
  • White cell blood count ≥ 3000 cells/mm3
  • Hemoglobin ≥ 9.0 g/dL (can be post-transfusion)
  • Platelets ≥ 100,000/mm3 (can not be post-transfusion)

Hepatic:

  • Aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 times upper limit of normal (ULN)
  • Total serum bilirubin ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal:

  • Creatinine levels ≤ 1.5 times ULN

Cardiovascular:

  • Baseline left ventricular ejection fraction greater than 50%
  • International Normalized ratio(INR) ≤ 1.5 times ULN, except patients on stable doses of coumadin or low molecular weight heparin NOTE: Patients on stable doses of coumadin or low molecular weight heparin are eligible if anticoagulant doses have been stable and no bleeding complications were recorded.
  • Partial thromboplastin time (PTT) ≤1.5 times ULN

This study was terminated due to drug availability and Phase II never opened.

Conditions
Ovarian Cancer
Being tested
Doxil (Pegylated Liposomal Doxorubicin), BIBF 1120
Keywords
BIBF 1120
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

Study groups in NCT01485874
Study groupRoleWhat they receive
Doxil + BIBF 1120ExperimentalNot described
Receives: Drug: Doxil (Pegylated Liposomal Doxorubicin); Drug: BIBF 1120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 12 months

Secondary outcomes (2)

  1. Phase I and II: Progression-Free Survival

    To determine the progression-free survival of Phase I and II patients with recurrent or resistant epithelial ovarian cancer treated with BIBF 1120 plus PLD.

    Measured: 12 months

  2. Phase I and II: Clinical Benefit

    To determine the rate of clinical benefit for Phase I and II defined as:

    • the number of patients experiencing an objective response or
    • a CA125 response, in the absence of disease progression by clinical or radiographic criteria
    • sustained stable disease ≥ 3 months by clinical and radiographic criteria

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionDec 2015
  4. Study completionDec 2015

Why it stopped: Funding withdrawn due to drug unavailability

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01485874
Sponsor's protocol ID
GYN10-149
Status last verified
Feb 2022
First submitted
2 Dec 2011
Last updated
15 Feb 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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^)

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Doxil (Pegylated Liposomal Doxorubicin) and BIBF 1120 in people with Ovarian Cancer, run by Hoosier Cancer Research Network at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Funding withdrawn due to drug unavailability). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Safety and Toxicity of Treatment Regimen (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01485874, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.

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