ABI-009 Trial in Patients With Advanced Non-hematologic Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00635284
First received: March 7, 2008
Last updated: September 14, 2011
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Solid Tumors
Drug: ABI-009
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of ABI-009 (Nab-rapamycin) Administered Weekly in Patients With Advanced Non-hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 administered weekly and pharmacokinetic parameters for ABI-009. [ Time Frame: End of Study (EOS) and Follow Up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of ABI-009 in this patient population [ Time Frame: End of Study (EOS) and Follow Up ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: December 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABI-009 Drug: ABI-009
nab-rapamycin
Other Name: nab-rapamycin

Detailed Description:

No extended description necessary

  Eligibility

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

Inclusion Criteria:

Each subject must meet the following criteria to be enrolled in this study.

  1. Male and female patients with histologically or cytologically confirmed diagnosis of cancer which is not amenable to curative therapy.
  2. Patients with advanced non-hematologic malignancies for whom no standard therapy exists.
  3. 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)
  4. 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.
  5. Female patients of child-bearing potential must have a negative serum pregnancy test within 7 days prior to first study drug administration.
  6. 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.
  7. Male patients must be surgically sterile or agree to the use of a barrier method of contraception.
  8. Life expectancy of > 3 months.
  9. ECOG Performance Status of 0-1.
  10. 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.
  11. Age ≥ 18 years of age.
  12. No major surgery within 4 weeks before treatment with ABI-009. (A biopsy is not considered major surgery).
  13. 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).
  14. No immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
  15. Required Initial Laboratory Data:

    • Hemoglobin > 9.0 g/dL
    • WBC ≥ 3,000/µl
    • ANC ≥ 1,500/µl
    • Platelet count ≥ 100,000/µl
    • Total Bilirubin ≤ ULN
    • SGOT (AST) SGPT (ALT) ≤ 1.5 x ULN ≤ 1.5 x ULN
    • Serum Cholesterol < 350 mg/dL
    • Serum Triglyceride < 300 mg/dL
  16. Adequate renal function with serum creatinine < 1.5 mg/dL and/or creatinine clearance (cockroft formula) ≥ 60 mL/min.
  17. No active alcohol abuse, drug addiction, or psychotic disorders.
  18. No known concomitant genetic or acquired immunosuppressive diseases (such as AIDS).
  19. 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:

Subjects who meet any of the following criteria will be excluded from the study.

  1. Pregnant or nursing women.
  2. 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.
  3. Patients have not recovered from adverse affects of radiation therapy or investigational agent within previous 28 days.
  4. Uncontrolled intercurrent illness that in the opinion of the investigator would limit compliance and tolerance to study requirements
  5. Patients with known brain metastases or leptomeningeal tumor involvement.
  6. Receiving any of the following: concomitant antitumor therapy or inhibitors of CYP3A4.
  7. Patients with history of interstitial lung disease and/or pneumonitis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635284

Locations
United States, California
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Ana M. Gonzalez, MD M.D. Anderson Cancer Center
Principal Investigator: Sant P. Chawla, MD Sarcoma Oncology Center
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00635284     History of Changes
Obsolete Identifiers: NCT00573677
Other Study ID Numbers: CA401
Study First Received: March 7, 2008
Last Updated: September 14, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014