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Carcinoma, Non-Small-Cell LungPhase 1NCT00826878

An Open-Label Study of QD Oral Administration of Tivozanib (AV-951) in Subjects With Non-Small Cell Lung Cancer (NSCLC)

A Phase 1 study testing Tivozanib (AV-951) in people with Carcinoma, Non-Small-Cell Lung, run by AVEO Pharmaceuticals, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a standard Phase 1b and 2a, multi-center, study design that will examine the safety, tolerability, and maximum tolerated dose of tivozanib (AV-951) with this dosing schedule, as well as overall response rate of tivozanib (AV-951) administration in NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Tivozanib (AV-951)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesUnited States
Study dates
Jan 2009to May 2011
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older, of either sex and of any race.
  • Histologically or cytologically confirmed NSCL.
  • Stage IIIB (with malignant pleural effusion) or stage IV or recurrent disease.
  • Subjects that have recurred or progressed following standard therapy or failed standard therapy; or subjects that are not candidates for or unwilling to undergo standard therapy.
  • Disease that is currently not amenable to curative surgical intervention, due to either non-resectability of the tumor or medical contraindications.
  • Prior VEGF directed therapy
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  • Prior chemotherapy
  • At least 4 weeks since prior immunotherapy (eg, IL-2, IFN, etc.) or biological therapy (eg, MABs) prior to the first dose of study drug.
  • At least 1 week since prior treatment with warfarin, acenocoumarol, fenprocoumon, or similar agents.
  • At least 4 weeks since prior systemic hormonal therapy.
  • At least 2 weeks since prior use of herbal preparations/supplements.
  • At least 2 weeks since prior treatment with CYP3A4 inducers or inhibitors.
  • At least 2 weeks since prior radiotherapy to ≤25% of bone marrow, or at least 4 weeks since prior radiotherapy to > 25% of bone marrow.
  • Measurable or evaluable disease; subjects enrolled in the Phase 2a study must have measurable disease by RECIST criteria.
  • ECOG performance 0-1 and life expectancy ≥ 3 months.
  • Ability to give written informed consent.

Who cannot join

  • Subjects with central lung lesions involving major blood vessels.
  • Primary CNS malignancies or symptomatic CNS metastases; subjects with previously treated brain metastasis will be allowed if the brain metastasis have been stable without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
  • Hematologic malignancies (including leukemia in any form, lymphoma, and multiple myeloma).
  • Hematologic abnormalities:
  • Serum chemistry abnormalities:
  • Significant cardiovascular disease
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  • Subjects with delayed healing of wounds, active gastric ulcers, or unhealed bone fractures.
  • Serious/active infection or infection requiring parenteral antibiotics.
  • Inadequate recovery from any prior surgical procedure or major surgical procedure within 6 weeks prior to administration of first dose of study drug.
  • Inability to comply with protocol requirements.
  • History of ≥ Grade 2 hemoptysis within 6 months prior to administration of first dose of study drug; ongoing bleeding (hemoptysis, hematemesis, hematochezia or melena) or history of clinically significant bleeding within 6 months prior to administration of first dose of study drug.
  • Cerebrovascular accident within 12 months prior to administration of first dose of study drug, or peripheral vascular disease with claudication on walking less than 1 block.
  • Deep venous thrombosis or pulmonary embolus within 6 months prior to administration of first dose of study drug.
  • Subjects with a "currently active" second primary malignancy other than non-melanoma skin cancers or nonmetastatic prostate cancer. Subjects are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy and have been disease free for >2 years.
  • If female, pregnant or lactating.
  • No childbearing potential or the use of effective contraception by all fertile male and female subjects during the study and for 30 days after the last dose of study drug. All subjects must agree to use a highly effective method of contraception (including their partner).
  • Known concomitant genetic or acquired immune suppression disease such as HIV.
  • Inadequate recovery from prior antineoplastic therapy.
  • Life-threatening illness or organ system dysfunction compromising safety evaluation.
  • Psychiatric disorder, altered mental status precluding informed consent or necessary testing.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Memorial Sloan-Kettering

    New York, New York, 10021

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase 1b/2a Open-Label Study to Evaluate the Safety and Activity of Once Daily Oral Administration of Tivozanib (AV-951) in Subjects With Non-Small Cell Lung Cancer

This is a standard Phase 1b and 2a, multi-center, study design that will examine the safety, tolerability, and maximum tolerated dose of tivozanib (AV-951) with this dosing schedule, as well as overall response rate of tivozanib (AV-951) administration in NSCLC.

Read the detailed description

The Phase 2a portion of the study was not conducted

Being tested
Tivozanib (AV-951)
Keywords
tivozanib, AV-951
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Tivozanib (AV-951)Drug

    Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) once daily continuously beginning on Day 1 for 4 weeks. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicity.

    Minimum of 8 weeks (2 consecutive dosing cycles), if tolerated.

Study groups in NCT00826878
Study groupRoleWhat they receive
Tivozanib (AV-951)ExperimentalNot described
Receives: Drug: Tivozanib (AV-951)

What is being measured

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

  1. Ph1b: To determine the safety, tolerability, and MTD of tivozanib (AV-951) administered orally QD in subjects with NSCLC

    Measured: 4 weeks (1 cycle)

  2. Ph2a: To determine the ORR of tivozanib (AV-951) administered orally once daily in subjects with NSCLC with no prior anti-angiogenic therapy

    Measured: 8 weeks (2 cycles)

Secondary outcomes (4)

  1. Ph1b: To evaluate the PK of tivozanib (AV-951) administered orally QD

    Measured: 8 weeks (2 cycles)

  2. Ph1b: To evaluate the preliminary antineoplastic activity of tivozanib (AV-951) administered orally QD

    Measured: 8 weeks (2 cycles)

  3. Ph2a: To determine the duration of complete and partial responses and time to disease progression (TTP) for subjects treated with tivozanib (AV-951)

    Measured: 8 weeks (2 cycles)

  4. Ph2a: To determine the safety and tolerability of tivozanib (AV-951) administered orally once a day

    Measured: 4 weeks (1 cycle)

Timeline

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

  1. First posted22 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionMar 2011
  4. Study completionMay 2011

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00826878
Sponsor's protocol ID
AV-951-08-105
Status last verified
Jun 2012
First submitted
21 Jan 2009
Last updated
28 Jun 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tivozanib (AV-951) in people with Carcinoma, Non-Small-Cell Lung, run by AVEO Pharmaceuticals, Inc. at 3 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 16 inclusion and 20 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: finished, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Ph1b: To determine the safety, tolerability, and MTD of tivozanib (AV-951) administered orally QD in subjects with NSCLC (time frame: 4 weeks (1 cycle)). 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 NCT00826878.

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 28 Jun 2012.

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