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Advanced Solid TumorPhase 1NCT01755390

A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors

A Phase 1 study testing Cabazitaxel (XRP6258) in people with Advanced Solid Tumor, run by Sanofi at 2 sites in 2 countries.

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

Primary Objective: To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of XRP6258 when given as a weekly 1-hour intravenous (i.v.) infusion for the first 4 consecutive weeks of each 5-week treatment cycle (Day 1, Day 8, Day 15, Day 22 of each 5-week treatment cycle). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Cabazitaxel (XRP6258)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
2 sitesin 2 countries
Study dates
Oct 1999to Oct 2002
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent prior to beginning protocol specific procedures
  • Histologically proven cancer at the first diagnosis. At study entry, it was desirable but not required to have histological or cytological proof of metastasis in the case of a 1 single metastatic target lesion.
  • Advanced neoplastic disease that was refractory to conventional treatment or for which no standard therapy existed
  • Progressive disease
  • Age 18-70 years
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
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  • Off previous anticancer (radio- or chemo-) therapy for at least 4 weeks and 6 weeks if prior nitrosoureas, mitomycin C; recovery from the toxic effects of prior treatment (Grade ≤1, except alopecia any grade)
  • Off previous immunotherapy for at least 1 week provided that patients did not have any residual signs of any toxicity
  • Adequate organ function including: neutrophils ≥2.0 × 109/L; platelets ≥100 × 109/L, creatinine <120 μmol/L (if borderline creatinine values, the creatinine clearance had to be ≥60 mL/min); total bilirubin within normal limit; alanine aminotransferase (ALT)/aspartate aminotransferase (AST)/alkaline phosphatase (ALP) ≤2.5-fold the upper normal limits of the institutional norms (ALP ≤2.5 UNL)
  • Patients registered in this trial had to be treated and followed at the participating centers
  • Patients who had received previous treatment with paclitaxel or docetaxel could be included provided that they did not have any residual signs of taxane toxicity (except alopecia any grade and peripheral neuropathy Grade 1)

Who cannot join

  • Hematological malignancies
  • Pregnant or lactating women or women of childbearing potential (eg, not using adequate contraception)
  • Symptomatic brain metastases
  • Previous extensive radiotherapy (>20% of bone marrow area)
  • Current peripheral neuropathy of any origin including significant residual symptoms due to the use of eg, vinca-alkaloids or platinum ≥Grade 2 according to the National Cancer Institute common terminology criteria for adverse events.
  • Other serious illness or medical conditions:
Show all 19Show fewer
  • Congestive heart failure or angina pectoris even if medically controlled, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias
  • Existence of significant neurological or psychiatric disorders including dementia or seizures
  • Active infection
  • Uncontrolled peptic ulcer, unstable diabetes mellitus, or other contraindications for the use of corticosteroids
  • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to patient registration
  • Concurrent treatment with any other anticancer therapy
  • Concomitant radiotherapy
  • Concomitant treatment with corticosteroids. However, patients receiving chronic treatment with corticosteroids (≤20 mg of methylprednisolone or ≤4 mg of dexamethasone or equivalent dose of other corticosteroids), for whatever reason, were eligible.
  • More than 2 prior chemotherapy regimens containing mitomycin C or nitrosoureas
  • More than 2 prior chemotherapy regimens for advanced disease
  • Prior history of severe allergic reaction to docetaxel or paclitaxel
  • Prior intensive chemotherapy with autologous stem cell rescue
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

France1 site

  • Sanofi

    Paris

Other trials in France

Spain1 site

  • Sanofi

    Barcelona

Other trials in Spain

About this study

Official title: A Phase I Dose Finding Study of XRP6258 Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumors

Primary Objective:

  • To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of XRP6258 when given as a weekly 1-hour intravenous (i.v.) infusion for the first 4 consecutive weeks of each 5-week treatment cycle (Day 1, Day 8, Day 15, Day 22 of each 5-week treatment cycle).

Secondary Objectives :

  • To define the safety profile of the drug
  • To establish the recommended dose and time interval for future Phase II trials
  • To determine the pharmacokinetic (PK) profile of XRP6258 in man
  • To assess the absolute oral bioavailability of XRP6258 at the i.v. recommended dose (following Protocol Amendment No. 2)
  • To look for evidence of antitumor activity
Read the detailed description

The duration of the study will include the following periods:

  • Pretreatment: 28 to 7 days before first infusion
  • Treatment: Weekly for the first four consecutive weeks during 5-week treatment cycle
  • Post-treatment: 3 - 4 weeks after last infusion.

Treatment may be continued until disease progression or unacceptable toxicity or patient refusal.

Being tested
Cabazitaxel (XRP6258)

What participants receive

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

  • Cabazitaxel (XRP6258)Drug

    Also called Jevtana

    Pharmaceutical form: infusion solution Route of administration: Intravenous

Study groups in NCT01755390
Study groupRoleWhat they receive
CabazitaxelExperimentalIV escalation part: XRP6258 administered as a 1-hour IV infusion on Days 1, 8, 15 and 22 of each 5-week cycle until evidence of disease progression, unacceptable toxicity or patient's withdrawal. Oral bioavailability part: XRP6258 administered at the dose of 8.4 mg/m² as an oral administration on Day 1 Cycle 1 and as a weekly 1-hour i.v. infusion at the subsequent weeks of treatment. Patients receiving oral administration at Day 1, Cycle 1 are to fast for 12 hours before and 4 hours after administration.
Receives: Drug: Cabazitaxel (XRP6258)

What is being measured

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

  1. Dose-limiting toxicity

    Measured: Up to 35 months

  2. Maximum tolerated dose

    Measured: Up to 35 months

Secondary outcomes (3)

  1. Number of patients with adverse events

    Measured: Up to 35 months

  2. Antitumor activity

    Measured by X-ray, ultrasound and/or scans

    Measured: Up to 35 months

  3. Pharmacokinetic parameters including Cmax, AUC(0-t), AUC, t, t1/2λz (h), Vss, CL, accumulation ratio, Tmax metabolite ratio and F (bioavailability)

    Measured: Up to 35 months

Timeline

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

  1. First posted24 Dec 2012 (estimated)
  2. Study startOct 1999
  3. Primary completionAug 2002
  4. Study completionOct 2002

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
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01755390
Sponsor's protocol ID
TED6189
Status last verified
Dec 2012
First submitted
17 Dec 2012
Last updated
24 Dec 2012
Results posted
No
Data monitoring committee
No

Publications

  • Fumoleau P, Trigo JM, Isambert N, Semiond D, Gupta S, Campone M. Phase I dose-finding study of cabazitaxel administered weekly in patients with advanced solid tumours. BMC Cancer. 2013 Oct 7;13:460. doi: 10.1186/1471-2407-13-460.

    PubMed 24099585

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cabazitaxel (XRP6258) in people with Advanced Solid Tumor, run by Sanofi at 2 sites in 2 countries.

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 11 inclusion and 19 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 24 Dec 2012. 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 France, Spain. 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?

Dose-limiting toxicity (time frame: Up to 35 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 NCT01755390, 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 24 Dec 2012.

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