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

NCT00635284 | Completed Phase 1

• 1 other identifier: CA401
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 administered weekly and pharmacokinetic parameters for ABI-009.

  End of Study (EOS) and Follow Up

Secondary Outcomes (1)

• Efficacy of ABI-009 in this patient population

  End of Study (EOS) and Follow Up

Study Arms (1)

ABI-009

EXPERIMENTAL

Drug: ABI-009

Interventions

ABI-009 DRUG

nab-rapamycin

Also known as: nab-rapamycin

ABI-009

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each subject must meet the following criteria to be enrolled in this study.
• Male and female patients with histologically or cytologically confirmed diagnosis of cancer which is not amenable to curative therapy.
• 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.
• 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.
• Male patients must be surgically sterile or agree to the use of a barrier method of contraception.
• Life expectancy of \> 3 months.
• ECOG Performance Status of 0-1.
• 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).

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study.
• 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
• Patients with known brain metastases or leptomeningeal tumor involvement.
• Receiving any of the following: concomitant antitumor therapy or inhibitors of CYP3A4.
• Patients with history of interstitial lung disease and/or pneumonitis.

Sponsors & Collaborators

• Celgene: lead

Study Sites (2)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Gonzalez-Angulo AM, Meric-Bernstam F, Chawla S, Falchook G, Hong D, Akcakanat A, Chen H, Naing A, Fu S, Wheler J, Moulder S, Helgason T, Li S, Elias I, Desai N, Kurzrock R. Weekly nab-Rapamycin in patients with advanced nonhematologic malignancies: final results of a phase I trial. Clin Cancer Res. 2013 Oct 1;19(19):5474-84. doi: 10.1158/1078-0432.CCR-12-3110.

  PMID: 24089446 BACKGROUND

Study Officials

• Ana M. Gonzalez, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Sant P. Chawla, MD

  Sarcoma Oncology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 13, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 18, 2019

Record last verified: 2019-10

Locations

US (2)