- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00531271
ABI-008 Trial in Patients With Metastatic Breast Cancer
A Phase I/II Trial of ABI-008 (Nab-docetaxel) in Patients With Metastatic Breast Cancer
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77030
- University of Texas M.D. Anderson Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Phase I Study
Each subject must meet the following criteria to be enrolled in this study.
- Pathologically confirmed adenocarcinoma of the breast with metastasis.
- No more than 2 prior chemotherapy regimen for metastatic breast cancer. Patient should have received anthracycline and may have received a taxane but not within 6 months for registration on the study.
- Patient may have measurable or evaluable disease.
- Patient may have non-measurable bone only disease.
- At least 4 weeks since prior cytotoxic chemotherapy. Patients should have recovered from all acute effects of such therapy.
- At least 4 weeks since radiotherapy, with full recovery.
- At least 4 weeks since recovery from major surgery, with full recovery.
- ECOG performance status 0-2.
- Age ≥18 years.
Patient must have the following blood counts at Baseline:
- WBC > 3.0 x 109 cells/L;
- ANC ≥ 1.5 x 109 cells/L;
- Platelets ≥ 100 x 109 cells/L;
- Hgb ≥ 9 grams/dL.
Patient has the following blood chemistry levels at Baseline:
- AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN);
- Total Bilirubin < ULN;
- Alkaline phosphatase ≤ 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis);
- Creatinine ≤ 1.5 mg/dL.
- Peripheral neuropathy Grade 0 or stable Grade 1, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0.
- If female of childbearing potential, serum pregnancy test is negative (within 72 hours of the first dose of study drug).
- If fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
- Life expectancy should be ≥ 3 months.
- Informed consent document has been obtained stating that the patient understands the investigational nature of the proposed treatment.
- If obese, a patient must be treated with doses calculated using his/her actual body surface area (BSA) (the physician must be comfortable treating at the full BSA dose regardless of BSA).
Phase II Study
- Pathologically confirmed adenocarcinoma of the breast with metastasis.
- Patients should have not received prior chemotherapy for their metastatic disease. If a taxane is used as adjuvant or neoadjuvant therapy, at least 12 months should have elapsed from the date of the last dose.
- Patient must have at least one measurable metastatic lesion.
- At least 4 weeks since prior cytotoxic chemotherapy. Patients should have recovered from all acute effects of such therapy.
- At least 4 weeks since radiotherapy, with full recovery.
- At least 4 weeks since major surgery, with full recovery.
- ECOG performance status 0-2.
- Age ≥18 years.
Patient must have the following blood counts at Baseline:
- WBC > 3.0 x 109 cells/L;
- ANC ≥ 1.5 x 109 cells/L;
- Platelets ≥ 100 x 109 cells/L;
- Hgb ≥ 9 grams/dL.
Patient has the following blood chemistry levels at Baseline:
- AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN);
- Total Bilirubin < ULN;
- Alkaline phosphatase ≤ 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis);
- Creatinine ≤ 1.5 mg/dL.
- Peripheral neuropathy Grade 0 or stable Grade 1, by NCI CTCAE v3.0.
- If female of childbearing potential, serum pregnancy test is negative (within 72 hours of the first dose of study drug).
- If fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
- Life expectancy should be ≥ 3 months.
- Informed consent document has been obtained stating that the patient understands the investigational nature of the proposed treatment.
Exclusion Criteria:
Phase I Study
Subjects who meet any of the following criteria will be excluded from the study.
- Concurrent therapy (chemotherapy, hormonal therapy, kinase inhibitors, immunotherapy, etc) for breast cancer. Bisphosphonates are allowed.
- Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris or recent myocardial infarction (within the last 6 months).
- History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer excluding non-melanomatous skin cancer and cervical carcinoma in situ.
- Patients who have received an investigational drug within the previous 4 weeks.
- Patient is currently enrolled in any other clinical study in which investigational procedures are performed or investigational therapies are administered. A patient may not enroll in such clinical trials while participating in this study.
- Pregnant or nursing women.
- Patients with history of allergic reactions attributed to solvent-based docetaxel(Taxotere).
- ECOG performance status 3-4.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
Phase II Study
Subjects who meet any of the following criteria will be excluded from the study.
- Prior neo-adjuvant or adjuvant chemotherapy is allowed. If a taxane was part of the adjuvant regimen, at least 12 months should have transpired since completion of taxane regimen.
- Concurrent therapy (chemotherapy, hormonal therapy, kinase inhibitors, immunotherapy, etc) for breast cancer.
- Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris or recent myocardial infarction (within the last 6 months).
- History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer excluding non-melanomatous skin cancer and cervical carcinoma in situ.
- Patients who have received an investigational drug within the previous 4weeks.
- Patient is currently enrolled in any other clinical study in which investigational procedures are performed or investigational therapies are administered.
- Pregnant or nursing women.
- Patients with history of allergic reactions attributed to solvent-based docetaxel(Taxotere).
- ECOG performance status 3-4.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel.
- Patients with tumor overexpression of HER2/neu.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-008 giver every three weeks.
Tidsramme: End of Study (EOS) and Follow Up
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End of Study (EOS) and Follow Up
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To evaluate the safety and tolerability of ABI-008 in the metastatic breast cancer patient population; and to determine the pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule.
Tidsramme: End of Study (EOS) and Follow Up
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End of Study (EOS) and Follow Up
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Nuhad Ibrahim, MD, M.D. Anderson Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CA302
Legemiddel- og utstyrsinformasjon, studiedokumenter
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