IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC)
IMP321 Phase 1 Study in Advanced or Metastatic Renal Cell Carcinoma Patients (P003)
2 other identifiers
interventional
24
1 country
1
Brief Summary
Single-center, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in ambulatory and day-hospital setting
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2005
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 12, 2006
CompletedFirst Posted
Study publicly available on registry
July 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedJanuary 7, 2010
January 1, 2010
2.9 years
July 12, 2006
January 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluate clinical and laboratory safety and tolerability profiles
3 months
Determine pharmacokinetic and pharmacodynamic parameters
3 months
Secondary Outcomes (1)
Secondary: Objective response rate (OR) using RECIST criteria
3 months
Interventions
subcutaneous injections of IMP321 every 14 days for three months (6 injections. Doses tested: 50, 250, 1,250, 6,250 or 30,000 µg
Eligibility Criteria
You may qualify if:
- Patient with metastatic renal clear cell (MRCC) adenocarcinoma, histologically proven by biopsy of the primary tumor and/or a metastasis. Prior nephrectomy is not required. The patient will be included in the study only if an efficacious cancer treatment can not be proposed.
- Patient to whom the currently available anticancer treatments are contra-indicated.
- Male or female 18 years or above. NB: Women must be either post-menopausal, rendered surgically sterile or practicing a reliable method of contraception (hormonal, intrauterine device or barrier). Pregnant women are excluded from this study.
- ECOG performance status 0-1.
- Expected survival longer than three months.
- 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.
You may not qualify if:
- Pregnancy, lactation or lack of effective contraception in fertile women of childbearing potential.
- Serious intercurrent infection within the 30 days prior to first administration.
- Known clinically active autoimmune disease.
- Known B or C active hepatitis.
- Known HIV positivity.
- Life threatening illness unrelated to cancer.
- Known cerebral metastases.
- Previous malignancies within the last two years other than 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.
- 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.
- IL-2 therapy or any other investigational agent within 30 days of first administration.
- Chemotherapy or radiotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to first administration of the study drug or lack of recovery from adverse events (to grade 1 or less toxicity according to CTCAE 3.0) due to agents administered more than 4 weeks earlier. Exception is made regarding the x-ray treatment for painful bone metastases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Immutep S.A.S.lead
- Umaniscollaborator
Study Sites (1)
Institut Gustave Roussy
Villejuif, 94805, France
Related Publications (1)
Brignone C, Escudier B, Grygar C, Marcu M, Triebel F. A phase I pharmacokinetic and biological correlative study of IMP321, a novel MHC class II agonist, in patients with advanced renal cell carcinoma. Clin Cancer Res. 2009 Oct 1;15(19):6225-31. doi: 10.1158/1078-0432.CCR-09-0068. Epub 2009 Sep 15.
PMID: 19755389RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard Escudier, M.D
Gustave Roussy, Cancer Campus, Grand Paris
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 12, 2006
First Posted
July 13, 2006
Study Start
September 1, 2005
Primary Completion
August 1, 2008
Study Completion
October 1, 2008
Last Updated
January 7, 2010
Record last verified: 2010-01