Status:
COMPLETED
IMP321 Plus First-line Paclitaxel in Metastatic Breast Carcinoma
Lead Sponsor:
Immutep S.A.S.
Collaborating Sponsors:
Umanis
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 cycle...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00349934
Start Date
July 1 2006
End Date
January 1 2010
Last Update
January 7 2010
Active Locations (3)
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1
Hôpital Européen Georges Pompidou
Paris, France, 75908
2
Hôpital Tenon
Paris, France
3
Centre René Huguenin
Saint-Cloud, France, 92210