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IMP321 Plus First-line Paclitaxel in Metastatic Breast Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00349934
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : January 7, 2010
Sponsor:
Collaborator:
Umanis
Information provided by:
Immutep S.A.S.

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Biological: IMP321 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IMP321 Phase I Study in Metastatic Breast Carcinoma Patients Receiving First-line Paclitaxel
Study Start Date : July 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: A
IMP321
Biological: IMP321

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.

Other Names:
  • LAG-3
  • hLAG-3Ig
  • CD223




Primary Outcome Measures :
  1. Evaluate clinical and laboratory safety and tolerability profiles [ Time Frame: 6 months ]
  2. Determine pharmacodynamic parameters [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Objective response rate (OR) using RECIST criteria [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349934


Locations
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France
Hôpital Européen Georges Pompidou
Paris, France, 75908
Hôpital Tenon
Paris, France
Centre René Huguenin
Saint-Cloud, France, 92210
Sponsors and Collaborators
Immutep S.A.S.
Umanis
Investigators
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Principal Investigator: Maya Gutierrez, M.D Centre René Huguenin
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: F. Triebel, Chief Medical Officer, Immutep S.A.
ClinicalTrials.gov Identifier: NCT00349934    
Other Study ID Numbers: P005
Umanis-CRO0425
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: January 2010
Keywords provided by Immutep S.A.S.:
Metastatic breast cancer
IMP321
hLAG-3Ig
LAG-3
CD223
Chemotherapy
Paclitaxel
Combination therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases