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ABI-009 (Nab-Rapamycin) in Patients With Advanced Non-Hematologic Malignancies

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: M.D. Anderson Cancer Center
Abraxis BioScience Inc.
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00573677
  Purpose

Primary Objectives:

  1. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of ABI-009.
  2. To characterize the toxicities of ABI-009.
  3. To determine the pharmacokinetic parameters for ABI-009 when given on a weekly schedule.

Secondary Objectives:

  1. To identify predictors and pharmacodynamic markers of response to ABI-009.
  2. To report anti-tumor activity of ABI-009 observed in this patient population.
  3. To evaluate SPARC and other molecular biomarkers in tumor tissue and peripheral blood and their possible correlation with efficacy outcomes.

Condition Intervention Phase
Solid Tumors
Drug: ABI-009
Phase I

MedlinePlus related topics:   Cancer   

Drug Information available for:   Sirolimus   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase I Trial of ABI-009 (Nab-Rapamycin) Administered Weekly in Patients With Advanced Non-Hematologic Malignancies

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To find the highest tolerable dose of ABI-009 that can be given to patients with solid tumors. [ Time Frame: 14 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effect of the study drug on the tumor and how long it stays in the body will also be studied. [ Time Frame: 14 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:   42
Study Start Date:   December 2007
Estimated Primary Completion Date:   February 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
ABI-009
Drug: ABI-009
45 mg/m^2 IV Over 30 Minutes on Days 1, 8, and 15 of each cycle, followed by a week without treatment.

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Male and female patients with histologically or cytologically confirmed diagnosis of cancer which is not amenable to curative therapy. For the purpose of this study, advanced disease will be defined as metastatic disease or locally advanced disease that is surgically unresectable and considered unmanageable with standard therapies such as radiation or systemic therapies.
  • Patients with advanced non-hematologic malignancies for whom no standard therapy exists.
  • Measurable disease by RECIST or evaluable disease (e.g., bone metastasis, pleural effusion, ascites, or lesions which do not fulfill RECIST criteria for metastatic disease)
  • Off all therapy (inclusive of investigational therapies) for at least 4 weeks prior to study drug administration OR off all daily or weekly therapy (inclusive of investigational therapies) for at least 2 weeks prior to study drug administration and without any side effects associated with these therapies.
  • Female patients of child-bearing potential must have a negative serum pregnancy test within 7 days prior to first study drug administration and must agree to the use of a physical method of non-hormonal contraception while patient is participating in this study and at least 6 months following discontinuation of study drug.
  • Female patients who are postmenopausal must have 12 months of amenorrhea, surgically sterile, or must agree to the use of a physical method of non-hormonal contraception while patient is participating in this study and at least 6 months following discontinuation of study drug.
  • Male patients must be surgically sterile or agree to the use of a barrier method of contraception while patient is participating in this study and at least 6 months following discontinuation of study drug.
  • Life expectancy of >/= 3 months.
  • ECOG Performance Status of 0-2.
  • Patients must be able to provide informed consent indicating knowledge of his/her disease process, the investigational nature of the therapy, alternatives, benefits, and risks including potential side effects.
  • Age >/= 18 years of age.
  • No major surgery within 4 weeks before treatment with ABI-009. (A biopsy is not considered major surgery).
  • No chemotherapy, hormonal therapy, immunotherapy or radiotherapy within 4 weeks before treatment with ABI-009 (6 weeks for previous treatment with nitrosoureas, mitomycin, or extensive radiotherapy) and no immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
  • No immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
  • Required Initial Laboratory Data: Hemoglobin >/= 9.0 g/dL, WBC >/= 3,000/microliter, ANC >/= 1,500/microliter, Platelet count >/= 100,000/microliter, Total Bilirubin </= ULN, SGOT (AST) </= 1.5 x upper limits of normal, SGPT (ALT) </= 1.5 x upper limits of normal, Serum Cholesterol </= 350 mg/dL, Serum Triglyceride </= 300 mg/dL.
  • Adequate renal function with serum creatinine </= 1.5 mg/dL and/or creatinine clearance (Cockcroft formula) >/= 60 mL/min.
  • No active alcohol abuse, drug addiction, or psychotic disorders.
  • No known concomitant genetic or acquired immunosuppressive diseases (such as AIDS).
  • If obese, a patient must be treated with doses calculated using his/her actual BSA (The physician must be comfortable treating at the full BSA dose regardless of BSA).

Exclusion Criteria:

  • Pregnant or nursing women.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition including macrolide (e.g. azithromycin, clarithromycin, dirithromycin, and erythromycin) and ketolide antibiotics.
  • Patients have not recovered from adverse affects of radiation therapy or investigational agent within previous 28 days.
  • Uncontrolled intercurrent illness that in the opinion of the investigator would limit compliance and tolerance to study requirements (eg: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, uncontrolled hypertension, coronary artery disease, or psychiatric illness/social situations).
  • Patients with known brain metastases or leptomeningeal tumor involvement should be excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Receiving any of the following: concomitant antitumor therapy or inhibitors of CYP3A4.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573677

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center
Abraxis BioScience Inc.

Investigators
Principal Investigator:     Ana Gonzalez-Angulo, MD     U.T.M.D. Anderson Cancer Center    
  More Information


Responsible Party:   U.T.M.D. Anderson Cancer Center ( Ana Gonzalez-Angulo, MD/Assistant Professor )
Study ID Numbers:   2006-1107
First Received:   December 12, 2007
Last Updated:   June 11, 2008
ClinicalTrials.gov Identifier:   NCT00573677
Health Authority:   United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Solid Tumors  
Advanced Non-Hematologic Malignancies  
ABI-009  
Nab-Rapamycin  

Study placed in the following topic categories:
Sirolimus
Clotrimazole
Miconazole
Tioconazole

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008




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