A Trial of ABI-010 & ABI-007 in Patients With Advanced Non-Hematologic Malignancies

NCT00820768 | Withdrawn Phase 1

• 1 other identifier: CA501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To determine MTD and DLT of ABI-010 given weekly every three weeks followed by one week of rest (Cycle 1). Determine MLD and DLT in combination with ABI-007; to characterize the toxicities of ABI-010 alone and in combination with ABI-007.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• The primary objectives of this study are to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of ABI-010 given weekly for 3 weeks followed by 1 week of rest (Cycle 1); to determine MTD and DLTs of ABI-010 given in combination

  EOS and Follow-Up

Secondary Outcomes (1)

• To determine the pharmacokinetic parameters for ABI-010 when given on a weekly schedule alone and in combination with ABI-007; determine preliminary efficacy of ABI-010 when given on a weekly schedule in combination with ABI-007

  EOS and Follow-Up

Study Arms (1)

ABI-010

EXPERIMENTAL

Drug: ABI-010

Interventions

ABI-010 DRUG

17-AAG and ABI-007

Also known as: 17-AAG and ABI-007

ABI-010

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed advanced solid tumor malignancy.
• Measurable or evaluable advanced solid tumors.
• Patients with advanced solid tumor malignancy who failed standard therapy or for whom no standard therapy exists. Patients failing standard therapy should have received no more than 3 prior chemotherapy regimens.
• Patients must have recovered for at least 3 weeks from prior treatment regimens and have no residual toxicity \> Grade 2 (with the exception of peripheral neuropathy which must have improved to ≤ Grade 1).
• Patient should have full recovery from any reversible side effects of prior chemotherapy.
• Patient should have full recovery for at least 4 weeks since major surgery.
• ECOG performance status 0-2.
• Age ≥18 years.
• Patient must have the following blood counts at Baseline:
• WBC ≥ 3.0 x 10 cells/L.
• ANC ≥ 1.5 x 10 cells/L.
• Platelets ≥ 100 x 10 cells/L.
• Hgb ≥ 9grams/dL.
• Patient must have the following blood chemistry levels at Baseline:
• AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN);

You may not qualify if:

• Concurrent therapy (chemotherapy, hormonal therapy, kinase inhibitors, immunotherapy, etc) for advanced solid tumor.
• Patients receiving known CYP450 3A4 inhibitors.
• Bisphosphonate therapy is allowed, however, patients should be stable on their current bisphosphonate, with no change, start or stop of treatment within 4 weeks prior to enrollment.
• Patients with known brain metastases or leptomeningeal tumor involvement should be excluded from this clinical trial.
• Uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study.
• 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 would affect the diagnosis or assessment of advanced solid tumor excluding non-melanomatous skin cancer and cervical carcinoma.
• Patients who have received an investigational drug within the previous 3 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 allergy or hypersensitivity to the study drug or its excipients.
• Patients with marked baseline prolongation of QT/QTc interval (\>450 milliseconds).

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

tanespimycin; Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Henry C. Pitot, MD

  Mayo Clinic

  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: January 9, 2009
• First Posted: January 12, 2009
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2014
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

US (1)