Metastatic Breast Cancer Clinical Trial
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | January 2010 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital Européen Georges Pompidou | Paris | |
France | Hôpital Tenon | Paris | |
France | Centre René Huguenin | Saint-Cloud |
Lead Sponsor | Collaborator |
---|---|
Immutep S.A. | Umanis |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate clinical and laboratory safety and tolerability profiles | 6 months | Yes | |
Primary | Determine pharmacodynamic parameters | 6 months | Yes | |
Secondary | Objective response rate (OR) using RECIST criteria | 6 months | No |
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