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Solid TumorsPhase 1NCT01553656

Dose-Finding Study of Cabozantinib (XL184) in Japanese Subjects With Advanced Cancer

A Phase 1 study testing cabozantinib capsules and cabozantinib tablets in people with Solid Tumors and Cancer, run by Exelixis at 2 sites in Japan.

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

The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics, pharmacogenomic (PGX) and preliminary efficacy following daily oral doses of cabozantinib (XL184) in Japanese patients with advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Solid Tumors, Cancer, NSCLC
What is being tested?
cabozantinib capsules and cabozantinib tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
2 sitesJapan
Study dates
Feb 2011to Jul 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Select Inclusion Criteria:

  • Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate.
  • NSCLC expansion cohort subjects must have confirmed NSCLC (Stage IIIb or IV) and documented activating mutations.
  • At least 4 weeks must have elapsed from the last anti-cancer therapy. At least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin.
  • Have adequate bone marrow function, adequate liver function, and adequate renal function.
  • Sexually active subjects (men and women of child-bearing potential (WOCBP)) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening.

Select Exclusion Criteria:

  • Symptomatic central nervous system (CNS) metastasis, or active CNS metastasis requiring medication.
  • WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period and for 4 months after the last dose of investigational product.
  • Women who are pregnant or breastfeeding.
  • Sexually active fertile men not using effective birth control for the entire study period and for 4 months after the last dose of investigational product if their partners are WOCBP.
  • Subjects who have uncontrolled intercurrent illness including, but not limited to, infection requiring systemic therapy, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled angina pectoris, uncontrolled peptic ulcer, cardiac arrhythmia requiring medication.
  • Subjects who are HIV antibody positive, HBs antigen positive, and/or HCV antibody positive.
  • Subjects with body cavity fluid retention which requires drainage.
  • Subjects with any major surgery within 8 weeks prior to study enrollment.
  • Subjects with major unhealed wounds or fracture.
  • Subjects with a history or concurrent diagnosis of gastrointestinal perforation.
  • Subjects with evidence of bleeding tendency or coagulopathy.
  • Subjects with a history of thromboembolism.
  • Subjects with a history of or concurrent pancreatitis.
  • Exposure to any investigational drug within 30 days of enrollment.
  • Subjects receiving radiation therapy or treatment with radionuclides within 6 to 2 weeks before first dose of XL184.
  • NSCLC expansion cohorts: subjects must not be diagnosed with another malignancy within 2 years before first dose of XL184.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • The Cancer Institute Hospital of the Japanese Foundation for Cancer Research (JFCR)

    Ariake, Koto, 135-8550

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

Other trials in Japan

About this study

Official title: Phase 1 Multiple Ascending Dose Study of XL184 Monotherapy in Japanese Subjects With Advanced or Metastatic Solid Tumors

The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics, pharmacogenomic (PGX) and preliminary efficacy following daily oral doses of cabozantinib (XL184) in Japanese patients with advanced or metastatic solid tumors. Also, the effect of XL184 in the treatment of non-small cell lung cancer (NSCLC) patients with various activating mutations will be evaluated at the recommended Phase 2 dose.

Being tested
cabozantinib capsules, cabozantinib tablets
Keywords
Advanced cancer, Metastatic, NSCLC
Medical subject headings
Neoplasms, Neoplasm Metastasis

What participants receive

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

  • cabozantinib capsulesDrug

    Also called XL184

    cabozantinib capsules administered as 25-mg and 100-mg strengths once-daily until disease progression

  • cabozantinib tabletsDrug

    Also called XL184

    cabozantinib tablets administered as 20-mg and 60-mg strengths once-daily until disease progression

Study groups in NCT01553656
Study groupRoleWhat they receive
Cabozantinib capsules and tabletsExperimentalSubjects will be enrolled in cohorts at different dose levels in order to determine the maximum tolerated dose of cabozantinib. Initially, subjects enrolled will receive the capsule formulation; other subjects will receive the tablet formulation.
Receives: Drug: cabozantinib capsules; Drug: cabozantinib tablets

What is being measured

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

  1. Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose

    To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of XL184 when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.

    Measured: Assessed in the clinic on Days 1 through 29

Secondary outcomes (3)

  1. Safety and tolerability of XL184

    Safety and tolerability of multiple doses of XL184 administered orally on a daily basis. Assessed from informed consent until at least 30 days after discontinuation.

    Measured: From study start to October 2014

  2. Plasma Pharmacokinetics

    Assess plasma pharmacokinetics of daily oral administration of XL184 from Treatment Day 1 to Day 29.

    Measured: Assessed in the clinic from Day 1 through Day 29

  3. Tumor response (preliminary anti-tumor activity)

    Assess tumor response after repeated administration of XL184 from screening until discontinuation. Assessed as best overall response by cohort by radiological response defined by RECIST criteria.

    Measured: Study start to October 2014

Timeline

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

  1. First posted14 Mar 2012 (estimated)
  2. Study startFeb 2011
  3. Primary completionMay 2015
  4. Study completionJul 2015

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
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01553656
Sponsor's protocol ID
XL184-014
Status last verified
Aug 2015
First submitted
9 Mar 2012
Last updated
20 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Nokihara H, Nishio M, Yamamoto N, Fujiwara Y, Horinouchi H, Kanda S, Horiike A, Ohyanagi F, Yanagitani N, Nguyen L, Yaron Y, Borgman A, Tamura T. Phase 1 Study of Cabozantinib in Japanese Patients With Expansion Cohorts in Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2019 May;20(3):e317-e328. doi: 10.1016/j.cllc.2018.12.018. Epub 2018 Dec 31.

    PubMed 30718102

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cabozantinib capsules and cabozantinib tablets in people with Solid Tumors and Cancer, run by Exelixis at 2 sites in Japan.

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

Who may be eligible to take part?

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 20 Aug 2015. 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 Japan. 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?

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (time frame: Assessed in the clinic on Days 1 through 29). 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 NCT01553656, 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 20 Aug 2015.

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Clinical Trial NCT01553656 | AzTrials