- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- University of Texas M.D. Anderson Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
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
|
End of Study (EOS) and Follow Up
|
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
|
End of Study (EOS) and Follow Up
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nuhad Ibrahim, MD, M.D. Anderson Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CA302
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Metastatisk brystkræft
-
Cairo UniversityIkke rekrutterer endnu
-
Abouqir General HospitalAlexandria UniversityRekrutteringBreast Udseende Rekonstruktion DisproportionEgypten
-
ETOP IBCSG Partners FoundationAfsluttetBreast Cancer Invasive NosItalien
-
Spanish Breast Cancer Research GroupHoffmann-La Roche; Roche Farma, S.AAfsluttetBreast Cancer Invasive NosSpanien
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital og andre samarbejdspartnereAfsluttetDen kliniske anvendelsesvejledning af Conebeam Breast CTKina
-
Ontario Clinical Oncology Group (OCOG)Afsluttet
-
Pomeranian Medical University SzczecinMaria Sklodowska-Curie National Research Institute of Oncology; Regional...UkendtBRCA1 mutation | Breast Cancer Invasive NosPolen
-
Aga Khan UniversityAfsluttetBrystkræft | Perforatorklap | Brysttumor | Oncoplasty | Breast-QPakistan
-
University Health Network, TorontoAfsluttetBreast Cancer Invasive Nos | Primær invasiv brystkræftCanada
-
KU LeuvenNovartisUkendtER Positive, HER2 Negative Breast Cancer NeoplasmaBelgien
Kliniske forsøg med ABI-008 (nab-docetaxel)
-
CelgeneAfsluttetHormonrefraktær prostatakræftForenede Stater
-
CelgeneAfsluttetKolorektale neoplasmerFrankrig
-
CelgeneAfsluttet
-
Aadi Bioscience, Inc.AfsluttetOndartet PEComaForenede Stater
-
Aadi Bioscience, Inc.Godkendt til markedsføringTSC1 | TSC2 | PEComa, ondartet | mTOR Pathway Abberation
-
CelgeneAfsluttetFaste tumorerForenede Stater
-
Aadi Bioscience, Inc.RekrutteringOndartet fast neoplasma | Neoplasmer | Kræft | Neoplasma Metastase | Solid tumor | Metastatisk kræft | Metastase | Avanceret solid tumor | Metastatisk fast tumor | Avanceret kræft | Svulst | Ondartet neoplasma | Ondartet tumor | Tumorer | Cancer Metastatisk | Tumor, fast | Ondartet fast tumor | TSC | TSC1 | TSC2 | Metastatisk neoplasmaKorea, Republikken, Forenede Stater, Puerto Rico
-
Aadi Bioscience, Inc.RekrutteringKræft | Endometriecancer | Svulst | Tilbagevendende endometriekarcinom | Endometrioid endometriecancer | Endometrioid tumorForenede Stater
-
Aadi Bioscience, Inc.National Cancer Institute (NCI)AfsluttetIkke-muskelinvasiv blærekræft (NMIBC)Forenede Stater