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Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II, Phase I | Treatment | Active | Over 18 | PX-171-007
NCT00531284 |
Trial Description
Summary Phase 1b: Approximately 12 subjects will be enrolled to evaluate the safety and tolerability of carfilzomib in subjects with relapsed solid tumors. Phase 2: Up to 134 evaluable subjects will be enrolled to evaluate the overall response rate of carfilzomib in subjects with relapsed non-small cell lung, small cell lung, ovarian and renal cell cancers. Eligibility Criteria Inclusion Criteria: Disease related Phase 1 Subjects: - Histologically confirmed advanced solid tumor for which standard therapy is no longer effective or does not exist, or patient refuses such therapy
Phase 2 Subjects: - Histologically confirmed advanced solid tumor diagnosis and:
- Non-small cell lung cancer (NSCLC): Failed at least one prior platinum-based chemotherapy regimen but not more than 3 prior therapies for metastatic disease
- Small cell lung cancer (SCLC): Failed only one prior chemotherapy regimen
- Ovarian: Failed at least one prior platinum-based chemotherapy regimen but not more than 4 therapies for metastatic disease
- Renal: Failed at least 2 prior chemotherapy regimens for metastatic disease
- Other solid tumor types: Failed at least one prior chemotherapy regimen for metastatic or relapsed disease and for which standard of care therapy is no longer effective or does not exist
- At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional CT scanning technique or > 1 cm in the largest dimension by spiral CT scanning (per RECIST criteria); or if, in the Principal Investigator's opinion, evaluable disease can be reliably and consistently followed, the subject may be eligible upon approval by the Proteolix, Inc. Medical Monitor
Demographic - Males and females > 18 years of age
- Life expectancy of more than three months
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Laboratory (obtained on Day -1 or Day 1, prior to first dose) - Adequate hepatic function, with bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times ULN
- absolute neutrophil count (ANC) > 1500/mm3, hemoglobin > 8 gm/dL , and platelet count > 100,000/ mm3
- Screening platelet count should be independent of platelet transfusions for at least 2 weeks
- Screening ANC should be independent of granulocyte- and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week
- Subjects may receive red blood cell (RBC) transfusions or receive supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines
- Calculated or measured creatinine clearance of ≥ 50 mL/minute, calculated using the formula of Cockcroft and Gault [(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL) x 0.85 (if female)]
- Serum creatinine < 2 mg/dL
Ethical/Other - Written informed consent in accordance with federal, local, and institutional guidelines
- Female subjects of childbearing potential must have a negative serum pregnancy test within three days of the first dose and agree to use dual methods of contraception during the study and for 3 months following the last dose of study drug. Post-menopausal females (>45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements. Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
- Subjects must be able to receive outpatient treatment and laboratory monitoring at the institute that administers the study treatment.
Exclusion Criteria: Disease Related - Chemotherapy with approved or investigative anticancer therapeutics, including steroid therapy, within 3 weeks prior to first dose
- Radiation therapy or immunotherapy within 4 weeks prior to first dose; localized radiation therapy within 1 week prior to first dose
- Subjects with brain metastases. Exception: Phase 1 subjects with brain metastases are permitted, but must have completed treatment and be stable for at least 8 weeks prior to first dose
- Participation in an investigational therapeutic study within 28 days prior to first dose
- Prior treatment with carfilzomib
Concurrent Conditions - Major surgery within 3 weeks prior to first dose
- Congestive heart failure (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to first dose
- Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose
- Known or suspected HIV infection or active hepatitis A, B, or C infection
- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose
Ethical / Other - Female subjects who are pregnant or lactating
- Psychiatric or medical conditions that in the opinion of the Investigator could interfere with treatment
Trial Contact Information
Trial Lead Organizations/Sponsors Proteolix | Alvin Wong, PharmD | | Study Director |
Trial Sites
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| U.S.A. |
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| Arizona |
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Scottsdale |
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| | | | | | | | | Premiere Oncology of Arizona |
| | | Kaye Nandin |
Ph: 480-860-5000 |
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Email:
knandin@premiereoncology.com |
| | | Michael Steven Gordon | Principal Investigator |
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| California |
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Beverly Hills |
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| | | | Tower Cancer Research Foundation |
| | | Marie Fuerst |
Ph: 310-285-7269 |
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Email:
rosenp@toweroncology.com |
| | | Peter Rosen, MD | Principal Investigator |
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| Maryland |
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Baltimore |
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| | | | Greenebaum Cancer Center at University of Maryland Medical Center |
| | | Judith Carter |
Ph: 410-328-3999 |
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Email:
jcarter1@umm.edu |
| | | Edward Sausville, MD, PhD | Principal Investigator |
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| Tennessee |
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Nashville |
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| | | | Sarah Cannon Cancer Center at Centennial Medical Center |
| | | Sheri Mersch |
Ph: 615-329-7249 |
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Email:
sheri.mersch@scresearch.net |
| | | Howard A. Burris | Principal Investigator |
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| Texas |
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San Antonio |
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| | | | South Texas Accelerated Research Therapeutics |
| | | Veloria Turner |
Ph: 210-593-5255 |
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Email:
veloria.turner@start.stoh.com |
| | | Kyriakos P. Papadopoulos | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00531284
Information obtained from ClinicalTrials.gov on March 25, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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