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Metastatic Breast CancerPhase 1NCT00349934

IMP321 Plus First-line Paclitaxel in Metastatic Breast Carcinoma

A Phase 1 study testing IMP321 in people with Metastatic Breast Cancer, run by Immutep S.A.S. at 3 sites in France.

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

Open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting in patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of weekly paclitaxel (80 mg/m² at D1, D8 and D15 of a 4-week cycle). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
IMP321
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
3 sitesFrance
Study dates
Jul 2006to Jan 2010
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with stage IV breast adenocarcinoma, histologically proven by biopsy of the primary tumor and/or a metastasis.
  • Female not pregnant (or with negative pregnancy test) or male.
  • Fertile patients must use effective contraception during and for 3 months after drug administration.
  • 18 years or above.
  • ECOG performance status 0-1.
  • Expected survival longer than three months.
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  • Resolution of toxicity of prior therapy to grade < 2 (except alopecia).
  • With or without prior adjuvant or neoadjuvant chemotherapy (authorized).
  • With or without hormone therapy in adjuvant and/or the advanced setting (authorized).
  • Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
  • Biphosphonate therapy must have started at least 4 weeks prior to first dosing of the study drug.
  • Asthma or chronic obstructive pulmonary disease allowed provided daily systemic corticosteroid therapy is not required.
  • Total white cell count ≥ 3.109/L.
  • Platelet count ≥ 100.109/L.
  • Hemoglobin > 9 g/dL or > 5.58 mmol/L.
  • Serum creatinine < 160 µmol/L.
  • Total bilirubin < 20 mmol/L, except for familial cholemia (Gilbert's disease).
  • Serum ASAT and ALAT < 3 times the upper limit of normal or < 5 times upper limit of normal if liver metastases are present.
  • Able to give written informed consent and to comply with the protocol.

Who cannot join

  • Prior chemotherapy for metastatic breast adenocarcinoma.
  • Disease-free interval < 12 months from last dose of adjuvant chemotherapy.
  • Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
  • Inflammatory carcinoma.
  • Systemic chemotherapy, hormone or endocrine therapy given as breast cancer therapy within 30 days prior to first dosing of the study drug.
  • Any investigational drug within 30 days prior to first dosing of the study drug.
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  • Candidate for treatment with trastuzumab or administration of trastuzumab within 30 days prior to first dosing of the study drug.
  • Known cerebral or leptomeningeal metastases.
  • Pregnancy or breast feeding.
  • Serious intercurrent infection within the 30 days prior to first dosing of the study drug.
  • Motor or sensory peripheral neuropathy ≥ 2 according to the National Cancer Institute criteria.
  • Congestive heart failure.
  • Active acute or chronic infection.
  • Active autoimmune disease requiring immunosuppressive therapy.
  • Known HIV positivity.
  • Life threatening illness unrelated to cancer.
  • Previous malignancies within the last two years other than breast carcinoma, successfully treated squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy.
  • Previous history of major psychiatric disorder requiring hospitalization or any current psychiatric disorder that would impede the patient's ability to provide informed consent or to comply with the protocol.
  • Corticosteroids unless used as substitutive therapy or before each injection of paclitaxel.
  • Past history of severe allergic episodes and/or Quincke edema.
  • Past or present history of any organic disorder likely to modify absorption, distribution or elimination of the study drug.
  • Alcohol or substance abuse disorder.
  • Radiotherapy within the 30 days prior to first dosing of the study drug.

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Hôpital Européen Georges Pompidou

    Paris, 75908

  • Hôpital Tenon

    Paris

  • Centre René Huguenin

    Saint-Cloud, 92210

Other trials in France

About this study

Official title: IMP321 Phase I Study in Metastatic Breast Carcinoma Patients Receiving First-line Paclitaxel

Open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting in patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of weekly paclitaxel (80 mg/m² at D1, D8 and D15 of a 4-week cycle). Three IMP321 doses (0.25, 1.25 and 6.25 mg) will be tested and given at D2 and D16 of this 4-week cycle, for 6 courses.

Read the detailed description

This study is an open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting with patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week cycle). Twenty mg i.v. dexamethasone will be given in the first cycle before each paclitaxel infusion. Corticosteroids will not be administered after the first chemotherapy cycle if the first 3 i.v. infusions of paclitaxel have been well tolerated.

Three IMP321 dose levels (0.25, 1.25 and 6.25 mg) will be evaluated in three cohorts of at lesat 8 patients. At any given dose level the patients will be administered one dose every two weeks for a total of 24 weeks (12 injections in total), separated by 13-day intervals free of IMP321 administration.

The study drug will be given by subcutaneous injection:

  • Cohort A: 0.25 mg s.c.
  • Cohort B: 1.25 mg s.c.
  • Cohort C: 6.25 mg s.c.

The repeated single doses will be administered on D2 and D16 of the 4-week cycles, on the day which follows chemotherapy.

After a screening performed between Week -2 and Day 1, patients will enter the main study period. Upon having completed the 6 cycles of IMP321 treatment at Week 23, they will have an ambulatory 'post-study' examination (at Week 25).

Cohort B will be undertaken once the safety and tolerability results of Cohort A have been satisfactory; the investigator will take his decision for involving the last 8 patients of the study after the 6th administration (Week 13 assessment) of the fifth patient of Cohort A. All cohorts will follow the same schedule

Standard clinical and laboratory safety examinations, CT scan and pharmacodynamic (PD) blood tests will be performed. A complete examination will be carried out at Week 13 (after the 6th drug dosing) and Week 25.

Being tested
IMP321
Keywords
Metastatic breast cancer, IMP321, hLAG-3Ig, LAG-3, CD223, Chemotherapy, Paclitaxel, Combination therapy
Medical subject headings
Breast Neoplasms

What participants receive

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

  • IMP321Biological

    Also called LAG-3, hLAG-3Ig, CD223

    This study is an open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting with patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week cycle).

    Three IMP321 dose levels (250 µg, 1,250 µg and 6,250 µg) will be evaluated in three cohorts of 8 patients. At any given dose level the patients will be administered one dose every two weeks for a total of 24 weeks (12 s.c. injections in total), separated by 13-day intervals free of IMP321 administration.

    The repeated single doses will be administered on D2 and D16 of the 4-week cycles, on the day which follows chemotherapy.

Study groups in NCT00349934
Study groupRoleWhat they receive
AExperimentalIMP321
Receives: Biological: IMP321

What is being measured

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

  1. Evaluate clinical and laboratory safety and tolerability profiles

    Measured: 6 months

  2. Determine pharmacodynamic parameters

    Measured: 6 months

Secondary outcomes (1)

  1. Objective response rate (OR) using RECIST criteria

    Measured: 6 months

Timeline

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

  1. First posted10 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionNov 2009
  4. Study completionJan 2010

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
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00349934
Sponsor's protocol ID
P005
Other IDs
Umanis-CRO0425
Status last verified
Jan 2010
First submitted
7 Jul 2006
Last updated
7 Jan 2010
Results posted
No
Data monitoring committee
No

Publications

  • Brignone C, Gutierrez M, Mefti F, Brain E, Jarcau R, Cvitkovic F, Bousetta N, Medioni J, Gligorov J, Grygar C, Marcu M, Triebel F. First-line chemoimmunotherapy in metastatic breast carcinoma: combination of paclitaxel and IMP321 (LAG-3Ig) enhances immune responses and antitumor activity. J Transl Med. 2010 Jul 23;8:71. doi: 10.1186/1479-5876-8-71.

    PubMed 20653948

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMP321 in people with Metastatic Breast Cancer, run by Immutep S.A.S. at 3 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 19 inclusion and 23 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 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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?

Evaluate clinical and laboratory safety and tolerability profiles (time frame: 6 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 NCT00349934, 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 7 Jan 2010.

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