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Carcinoma, Renal CellPhase 2NCT00569946

Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)

A Phase 2 study testing AG-013736 in people with Carcinoma, Renal Cell, run by Pfizer at 18 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

To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC) Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
AG-013736
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
18 sitesJapan
Study dates
12 Dec 2007to 30 Oct 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Patients histologically diagnosed as metastatic renal cell cancer with a component of clear cell cancer.
  • Patients who are refractory to cytokine therapy as 1st line.
  • Patients who experienced nephrectomy.
  • Patients with at least 1 target lesion, as defined by RECIST.
  • Patients with no uncontrolled hypertension.

Who cannot join

  • Gastrointestinal abnormalities
  • Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2/3A4 inducers.
  • Active seizure disorder or evidence of brain metastases.
  • Patients with hemoptysis.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Japan18 sites

  • Akita University Hospital

    Akita, 010-8543

  • Tokyo Women's Medical University Medical Center East

    Arakawa-ku, Tokyo, 116-8567

  • National Cancer Center

    Chuo-ku, Tokyo, 104-8503

  • National Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kyushu University Hospital, Department of Urology

    Fukuoka, 812-8582

  • Hamamatsu University School of Medicine University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • National Cancer Center East Hospital

    Kashiwa, Chiba, 277-8577

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Iwate Medical University

    Morioka, Iwate, 020-8505

  • Kochi Medical School Hospital

    Nankoku-shi, Kochi, 783-8505

  • Osaka University Hospital

    Osaka, 565-0871

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Kinki University Hospital

    Sayama, Osaka, 589-8511

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610

  • Tokushima University Hospotal

    Tokushima, 770-8503

  • Tsukuba University Hospital

    Tsukuba, Ibaraki, 305-8576

  • Yamagata University Hospital

    Yamagata, 990-9585

Other trials in Japan

About this study

Official title: PHASE 2 STUDY OF AG-013736 AS SECOND-LINE TREATMENT IN PATIENTS WITH METASTATIC RENAL CELL CANCER

To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)

Being tested
AG-013736
Keywords
AG-013736, RCC, Phase 2
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • AG-013736Drug

    AG-013736 5 mg BID will be administered orally on continuous schedule. Cycle length is 28 days. If the drug is well tolerated at 5 mg BID, the dose of AG-013736 may be titrated to 7 mg BID and then to a maximum of 10 mg BID.

    Number of cycles: until progression or unacceptable toxicity develops.

Study groups in NCT00569946
Study groupRoleWhat they receive
AG-013736ExperimentalNot described
Receives: Drug: AG-013736

What is being measured

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

  1. Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment

    Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.

    Measured: Up to 765 days of treatment at the data cut-off date

  2. Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment

    Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.

    Measured: Up to 765 days of treatment at the data cut-off date

Secondary outcomes (11)

  1. Progression-Free Survival (PFS)

    Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).

    Measured: Up to 1709 days of treatment

  2. Time to Tumor Progression (TTP)

    Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).

    Measured: Up to 1709 days of treatment

  3. Duration of Response

    Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

    Measured: Start of first confirmed CR or PR to the date of the first event (PD or death) or the last tumor assessment, whichever came first, assessed up to 1709 days.

  4. Overall Survival (OS)

    OS was defined as the time from date of first dose of AG-013736 to date of death due to any cause.

    Subjects in whom death is not reported will have their event time censored on the last date the subject is known to be alive.

    Measured: Up to 2002 days (maximum duration of treatment plus follow-up observation)

  5. Number of Participants Analyzed for Population Pharmacokinetics of AG-013736

    Population pharmacokinetic analysis of AG-013736 is conducted by combining current study data with other AG-013736 studies.

    Measured: Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose

  6. Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1)

    Measured: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)

  7. Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2)

    Measured: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)

  8. Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3)

    Measured: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)

  9. Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT)

    Measured: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)

  10. Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)

    Measured: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)

  11. Number of Participants With Adverse Events

    Number of participants with any adverse events, adverse events graded as Common Terminology Criteria (CTCAE) for Adverse Events Version 3.0 Grade 3 or higher , serious adverse events, or adverse events resulted in discontinuation.

    Measured: Up to 1709 days of treatment plus 28-days follow-up

Timeline

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

  1. First posted10 Dec 2007 (estimated)
  2. Study start12 Dec 2007
  3. Primary completion26 Feb 2010
  4. Study completion30 Oct 2012

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 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00569946
Sponsor's protocol ID
A4061035
Status last verified
May 2019
First submitted
7 Dec 2007
Last updated
5 Jun 2019
Data monitoring committee
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Schindler E, Amantea MA, Karlsson MO, Friberg LE. A Pharmacometric Framework for Axitinib Exposure, Efficacy, and Safety in Metastatic Renal Cell Carcinoma Patients. CPT Pharmacometrics Syst Pharmacol. 2017 Jun;6(6):373-382. doi: 10.1002/psp4.12193. Epub 2017 May 26.

    PubMed 28378918

  • Eto M, Uemura H, Tomita Y, Kanayama H, Shinohara N, Kamei Y, Fujii Y, Umeyama Y, Ozono S, Naito S, Akaza H; Japan Axitinib Phase II Study Group. Overall survival and final efficacy and safety results from a Japanese phase II study of axitinib in cytokine-refractory metastatic renal cell carcinoma. Cancer Sci. 2014 Dec;105(12):1576-83. doi: 10.1111/cas.12546. Epub 2014 Nov 25.

    PubMed 25283266

  • Tomita Y, Uemura H, Fujimoto H, Kanayama HO, Shinohara N, Nakazawa H, Imai K, Umeyama Y, Ozono S, Naito S, Akaza H; Japan Axitinib Phase II Study Group. Key predictive factors of axitinib (AG-013736)-induced proteinuria and efficacy: a phase II study in Japanese patients with cytokine-refractory metastatic renal cell Carcinoma. Eur J Cancer. 2011 Nov;47(17):2592-602. doi: 10.1016/j.ejca.2011.07.014. Epub 2011 Aug 31.

    PubMed 21889330

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AG-013736 in people with Carcinoma, Renal Cell, run by Pfizer at 18 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?

The sponsor lists 5 inclusion and 4 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 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment (time frame: Up to 765 days of treatment at the data cut-off date). 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 NCT00569946, which also lists 3 linked publications.

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 5 Jun 2019.

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