NCT01323933

Brief Summary

Analysis of safety, tolerability, and PK data will provide information that will guide future development of AB0024.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 3, 2012

Status Verified

May 1, 2012

Enrollment Period

1.8 years

First QC Date

March 24, 2011

Last Update Submit

May 2, 2012

Conditions

Neoplasms

Keywords

Solid tumorsOncologyCancer

Outcome Measures

Primary Outcomes (1)

  • To characterize the safety, tolerability, and pharmacokinetics (PK) of AB0024 after multiple intravenous (IV) administrations in patients with advanced solid tumors.

    Day 71

Secondary Outcomes (1)

  • To measure the tumor response by modified Response Evaluation Criteria in Solid Tumors (RECIST) and to evaluate the formation of anti-AB0024 antibodies.

    Day 71

Study Arms (1)

AB0024

EXPERIMENTAL

The starting dose for Part A will be 1 mg/kg. Subsequent doses of 3, 10, and 20 mg/kg are planned. Three to 6 patients will be enrolled using a 3 + 3 design. Doses of AB0024 will be administered on Days 1, 15, 29, and 43 to characterize the safety, tolerability, and PK. The dose expansion phase of the study will begin upon completion of the dose escalation phase. Up to 20 patients will be enrolled into one or two cohorts of Part B. The first expansion cohort will be dosed up to the MTD defined as the highest dose level with an observed incidence of DLT in \<33% of patients enrolled from Part A.

Drug: AB0024

Interventions

AB0024DRUG

Comparison of different dosages of drug

AB0024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to, intolerant of, or for which no standard of therapy is available
  • Measurable or evaluable disease
  • ECOG Performance Status of ≤2
  • No known active central nervous system (CNS) tumors or CNS metastases
  • Adequate organ function

You may not qualify if:

  • Myocardial infarction within the last 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association Classification \> Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
  • History of surgery within 28 days prior to enrollment or anticipated surgery during the study period
  • Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 28 days of study Day 1 (six weeks for nitrosoureas, mitomycin C, antibodies, or molecular agents with t½ \>10 days); (concurrent use of hormone therapy for breast or prostate cancer is permitted)
  • Treatment with immune modulators including, but not limited to, cyclosporine and tacrolimus within two weeks prior to enrollment
  • Concurrent or prior (within 30 days of study Day 1) anticoagulation therapy; (low-dose warfarin \[\<2 mg/day\] for prophylaxis against central venous catheter thrombosis is allowed)
  • Patient with tumor that is infiltrating or invading a major blood vessel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Barker HE, Cox TR, Erler JT. The rationale for targeting the LOX family in cancer. Nat Rev Cancer. 2012 Jul 19;12(8):540-52. doi: 10.1038/nrc3319.

    PMID: 22810810DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

simtuzumab

Study Officials

  • Patricia LoRusso, DO

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Anthony Tolcher, MD

    South Texas Accelerated Research Therapeutics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 28, 2011

Study Start

June 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 3, 2012

Record last verified: 2012-05

Locations

US(2)