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Metastatic Cancer (Different Solid Tumour Types)Phase 1VOTRAGENCT01642017

Phase I Clinical and Pharmacokinetic Study of Pazopanib in a Population of Frail Elderly Patients According SIOG Criteria

A Phase 1 study testing Pazopanib in people with Metastatic Cancer (Different Solid Tumour Types), run by Institut Claudius Regaud at 4 sites in France.

Terminated

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

Official record
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Trial summary

This is an open-label, multicenter, non-randomized, phase 1 dose escalation clinical trial to determine the MTD (Maximal Tolerated Dose) of Pazopanib in a population of frail elderly patients, selected according to the International Society of Geriatric Oncology (SIOG)classification (Group 2). Read more about this study

Who is it for?
Ages 75 years and older
What is being tested?
Pazopanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesFrance
Study dates
22 Nov 2012to Mar 2018
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up.
  • Age ≥ to 75 years old
  • Patient with metastatic cancer among renal cell carcinoma, non small cell lung cancer, pancreatic neuroendocrine cancer, sarcoma , ovarian cancer , thyroid cancer, bladder cancer or breast cancers, who cannot receive any treatment with curative intent.
  • WHO PS ≤ 2,
  • Life expectancy ≥ 3 months,
  • Group 2 (vulnerable) according to SIOG classification,
  • Adequate organ system function as defined in provided Table

Who cannot join

  • Patient with a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with PSA <1.0; or who has undergone potentially curative therapy with no evidence of that disease for five years, and who is deemed at low risk for recurrence by his/her treating physician,
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug.
  • Criteria of group 3 according to SIOG classification,
  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
  • •Active peptic ulcer disease
  • •Known intraluminal metastatic lesion/s with risk of bleeding
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  • •Inflammatory bowel disease (e.g. ulcerative colitis, crohn's disease), or other gastrointestinal conditions with increased risk of perforation
  • •History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
  • •Malabsorption syndrome
  • •Major resection of the stomach or small bowel.
  • Presence of uncontrolled infection.
  • Corrected QT interval (QTc) > 480 msecs using Bazett's formula
  • Anti-coagulants treatment (preventive or curative)
  • History of any one or more of the following cardiovascular conditions within the past 6 months:
  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • Coronary artery bypass graft surgery
  • Symptomatic peripheral vascular disease
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  • Poorly controlled hypertension
  • History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer
  • Evidence of active bleeding or bleeding diathesis.
  • 14 Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
  • 15. Hemoptysis in excess of 2.5 mL (or one half teaspoon) within 8 weeks of first dose of study drug.
  • 16. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
  • 17. Unable or unwilling to discontinue use of prohibited medications list in Appendix 7 for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
  • 18. Treatment with any of the following anti-cancer therapies:
  • radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
  • chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
  • 19. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
  • 20. Patient not affiliated with social system in France.
  • 21. Patient deprived of liberty or under guardianship

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Hôpital Saint André

    Bordeaux, 33075

  • Centre François BACLESSE

    Caen, 14076

  • Centre Léon BERARD

    Lyon, 69008

  • Institut Claudius REGAUD

    Toulouse, 31052

Other trials in France

About this study

This is an open-label, multicenter, non-randomized, phase 1 dose escalation clinical trial to determine the MTD (Maximal Tolerated Dose) of Pazopanib in a population of frail elderly patients, selected according to the International Society of Geriatric Oncology (SIOG)classification (Group 2).

It is expected that a total number of 30 patients maximum will be enrolled in the study on 30 months : 18 months accrual - 12 months follow up.

Read more

Eligible patients will be enrolled into a standard 3+3 design with a starting dose of Pazopanib administered orally at 400 mg per day, in 28-day cycles. Then, further dose levels will be explored.

Toxicity of the schedule will be assessed during the first cycle. Patients will receive study medication until disease progression. After treatment discontinuation, patients will be followed during one year.

Being tested
Pazopanib
Keywords
Phase I, Pazopanib, Frail elderly patients, Pharmacokinetics
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • PazopanibDrug

    Pazopanib will be administered orally at the starting dose of 400 mg/day in 28-days cycles ; barring limiting toxicities the dose of pazopanib will escalate in several steps (a maximum of 3 dose levels are defined : 400, 600 and 800 mg/day). The pazopanib will be administered at the same dosa until disease progression.

Study groups in NCT01642017
Study groupRoleWhat they receive
PazopanibExperimentalPazopanib : 3 dose levels are defined : 400, 600 and 800 mg per day.
Receives: Drug: Pazopanib

What is being measured

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

  1. Dose limiting toxicity (DLT) incidence (according DLT definition) during the first treatment cycle with pazopanib (28 days)

    The MTD (Maximum Tolerated Dose) is defined as the highest dose level for which 6 patients were treated with a maximum of 1 patient presenting a DLT during the first cycle of treatment

    Measured: 7.5 years

Secondary outcomes (4)

  1. Safety and tolerability assessments using the descriptions and grading scales found in the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0 NCI

    Measured: 7.5 years

  2. Measure of Pazopanib plasma concentration during treatment period (objective : assessment of pharmacokinetics of Pazopanib in this population)

    Plasma concentrations of pazopanib will be determined using a validated LC-MS-MS method -

    Measured: .8 time points (cycle 1 Day 1), 3 time points (cycle 1 D15) and 1 pre dose time point each day 1 of the following cycles (over a period of 7.5 years for measures in all patients)

  3. Geriatric criteria measured by comprehensive geriatric assessment which evaluate medical, functional and psychosocial aspects of elderly patients

    The impact of treatment on the geriatric assessment will be done using :

    • G8 : screening test
    • ADL: Activities Daily Living
    • IADL: Instrumental Activities Daily Living
    • MMSE: Mini-mental State Examination
    • SPPB: Short Physical Performance Battery
    • MNA: Mini-nutritional Assessment
    • CAM: Confusion Assessment Method
    • GDS-15: Geriatric Depression Scale
    • CIRS-G: Cumulative Illness Rating Scale for Geriatrics,

    Measured: 7.5 years

  4. Rate of objective response according to RECIST criteria

    Tumor assessment will be performed at screening visit, every 2 cycles and at the end of study visit and anytime if clinically indicated

    Measured: 7.5 years

Timeline

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

  1. First posted17 Jul 2012 (estimated)
  2. Study start22 Nov 2012
  3. Primary completionSep 2017
  4. Study completionMar 2018

Why it stopped: Slow recruitment rate

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01642017
Sponsor's protocol ID
11GENE06
Acronym
VOTRAGE
Status last verified
Apr 2026
First submitted
13 Jul 2012
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No

Publications

  • Mourey L, Le Louedec F, Ravaud A, Paludetto MN, Digue L, Gomez-Roca CA, Valentin T, Balardy L, Olivier P, Cabarrou B, Filleron T, Chatelut E. VOTRAGE study: Phase I dose-escalation study of pazopanib in unfit older patients. J Geriatr Oncol. 2021 Jun;12(5):759-764. doi: 10.1016/j.jgo.2021.02.006. Epub 2021 Mar 11.

    PubMed 33715996

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pazopanib in people with Metastatic Cancer (Different Solid Tumour Types), run by Institut Claudius Regaud at 4 sites in France.

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 7 inclusion and 35 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. 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: Slow recruitment rate). 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?

Dose limiting toxicity (DLT) incidence (according DLT definition) during the first treatment cycle with pazopanib (28 days) (time frame: 7.5 years). 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 NCT01642017, 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 14 Apr 2026.

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