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Advanced Solid TumorsPhase 1NCT01293630

A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors

A Phase 1 study testing Ombrabulin (AVE8062), Paclitaxel and Carboplatin in people with Advanced Solid Tumors, run by Sanofi 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 primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
Ombrabulin (AVE8062), Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesJapan
Study dates
Jan 2011to Oct 2013
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with advanced solid tumor for which the combination paclitaxel and carboplatin is potentially effective such as lung cancer, epithelial ovarian cancer.
  • Patients who have signed and dated an Institutional Review Board (IRB)-approved patient informed consent form prior to study enrollment or performance of any study-specific procedures.

Who cannot join

  • Less than 20 or above 75 years of age ECOG performance status ≥2.
  • Patients with more than 1 line of previous chemotherapy for advanced or metastatic disease (adjuvant/neoadjuvant and targeted agents [eg gefitinib] excluded)
  • Concurrent treatment with any other anticancer therapy (except palliative radiotherapy),
  • Women of childbearing potential who does not agree with contraception.
  • Washout period of less than 28 days from prior anticancer therapies
  • Symptomatic brain metastases and carcinomatous leptomeningitis.
Show all 14Show fewer
  • Other serious illness or medical conditions
  • Current peripheral neuropathy ≥grade 2 and ototoxicity,
  • Absolute neutrophils counts<1.5 x 10E9/L. - Platelets count<100 x 10E9/L. - hemoglobin <9.0 g/dL (without red blood cell transfusion within 28 days before the test). - Creatinine Clearance<55 mL/min. - Total bilirubin >upper normal limits of the institutional norms. - ALT/AST >1.5 times the upper normal limits of the institutional norms. - AP>2.5 times the upper normal limits of the institutional norms.
  • Medical history of myocardial infarction, angina pectoris, congestive heart failure, coronary artery bypass graft , arrhythmia , stroke or history of arterial or venous thrombo-embolism within the past 180 days requiring anticoagulants.
  • Patient with a LVEF <50% by echocardiography.
  • Patient with uncontrolled hypertension and patient with organ damage related to hypertension such as left ventricular hypertrophy or grade 2 ocular fundoscopic changes or kidney impairment.
  • Hypertension defined as systolic BP >140 mmHg or diastolic BP >90 mmHg on two repeated measurements at 30 minutes interval.
  • 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 1 country.

Japan2 sites

  • Investigational Site Number 392002

    Akashi-Shi

  • Investigational Site Number 392001

    Hidaka-Shi

Other trials in Japan

About this study

Official title: An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Paclitaxel and Carboplatin Every 3 Weeks in Patients With Advanced Solid Tumors

The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors.

Secondary Objectives:

  • To assess the overall safety profiles of the combination therapy
  • To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, paclitaxel, and carboplatin when used in combination
  • To document the objective tumor response
Read the detailed description

The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period.

Being tested
Ombrabulin (AVE8062), Paclitaxel, Carboplatin

What participants receive

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

  • Ombrabulin (AVE8062)Drug

    Pharmaceutical form:solution

    Route of administration: intravenous

  • PaclitaxelDrug

    Pharmaceutical form:solution

    Route of administration: intravenous

  • CarboplatinDrug

    Pharmaceutical form:solution

    Route of administration: intravenous

Study groups in NCT01293630
Study groupRoleWhat they receive
Cohort - 1 through 5ExperimentalAVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks
Receives: Drug: Ombrabulin (AVE8062); Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1

    Measured: 3 weeks

Secondary outcomes (24)

  1. The number of treatment emergent adverse events

    Measured: 30 days after the last injection

  2. The number of serious adverse events

    Measured: 30 days after the last injection

  3. The number of laboratory abnormalities

    Measured: 30 days after the last injection

  4. Pharmacokinetic parameter of ombrabulin: Cmax

    Measured: Day 1-2 at Cycle 1

  5. Pharmacokinetic parameter of RPR258063: tmax

    Measured: Day 1-2 at Cycle 1

  6. Pharmacokinetic parameter of paclitaxel: Cmax

    Measured: Day 1-3 at Cycle 1

  7. Pharmacokinetic parameter of carboplatin (free and total platinum): Cmax

    Measured: Day 1-3 at Cycle 1

  8. Investigator determination of response

    Measured: 30 days after the last injection

  9. Pharmacokinetic parameter of ombrabulin: AUC

    Measured: Day 1-2 at Cycle 1

  10. Pharmacokinetic parameter of ombrabulin: CL

    Measured: Day 1-2 at Cycle 1

  11. Pharmacokinetic parameter of ombrabulin: Vss

    Measured: Day 1-2 at Cycle 1

  12. Pharmacokinetic parameter of ombrabulin: t 1/2

    Measured: Day 1-2 at Cycle 1

  13. Pharmacokinetic parameter of RPR258063: Cmax

    Measured: Day 1-2 at Cycle 1

  14. Pharmacokinetic parameter of RPR258063: AUC

    Measured: Day 1-2 at Cycle 1

  15. Pharmacokinetic parameter of RPR258063: t 1/2

    Measured: Day 1-2 at Cycle 1

  16. Pharmacokinetic parameter of RPR258063: Metabolic Ratio

    Measured: Day 1-2 at Cycle 1

  17. Pharmacokinetic parameter of paclitaxel: AUC

    Measured: Day 1-3 at Cycle 1

  18. Pharmacokinetic parameter of paclitaxel: CL

    Measured: Day 1-3 at Cycle 1

  19. Pharmacokinetic parameter of paclitaxel: Vss

    Measured: Day 1-3 at Cycle 1

  20. Pharmacokinetic parameter of paclitaxel: t 1/2

    Measured: Day 1-3 at Cycle 1

  21. Pharmacokinetic parameter of carboplatin (free and total platinum): AUC

    Measured: Day 1-3 at Cycle 1

  22. Pharmacokinetic parameter of carboplatin (free and total platinum): CL

    Measured: Day 1-3 at Cycle 1

  23. Pharmacokinetic parameter of carboplatin (free and total platinum): Vss

    Measured: Day 1-3 at Cycle 1

  24. Pharmacokinetic parameter of carboplatin (free and total platinum): t 1/2

    Measured: Day 1-3 at Cycle 1

Timeline

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

  1. First posted10 Feb 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionOct 2013
  4. Study completionOct 2013

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01293630
Sponsor's protocol ID
TCD11270
Other IDs
U1111-1115-2568
Status last verified
Oct 2015
First submitted
8 Feb 2011
Last updated
30 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Matsumoto K, Sunaga Y, Ecstein-Fraisse E, Fujiwara K. Phase I study of ombrabulin in combination with paclitaxel and carboplatin in Japanese patients with advanced solid tumors. Int J Gynecol Cancer. 2024 Apr 1;34(4):586-593. doi: 10.1136/ijgc-2022-003880.

    PubMed 37989482

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ombrabulin (AVE8062), Paclitaxel and Carboplatin in people with Advanced Solid Tumors, run by Sanofi 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?

The sponsor lists 2 inclusion and 14 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 30 Oct 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?

The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1 (time frame: 3 weeks). 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 NCT01293630, 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 30 Oct 2015.

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