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First-in-human Study of AB0024 to Evaluate Safety and Tolerability in Adults With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01323933
First received: March 24, 2011
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Neoplasms
 Drug: AB0024
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB0024 in Adult Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • To characterize the safety, tolerability, and pharmacokinetics (PK) of AB0024 after multiple intravenous (IV) administrations in patients with advanced solid tumors. [ Time Frame: Day 71 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To measure the tumor response by modified Response Evaluation Criteria in Solid Tumors (RECIST) and to evaluate the formation of anti-AB0024 antibodies. [ Time Frame: Day 71 ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: June 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AB0024

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
Comparison of different dosages of drug

Detailed Description:

This is a first-in-human, open-label, sequential dose escalation study to evaluate AB0024 in patients with advanced solid tumors. The study will consist of two parts: Part A will be a dose escalation, and Part B will be a dose expansion.The primary objective of this study is to characterize the safety, tolerability, and PK of AB0024 after multiple IV administrations in patients with advanced solid tumors. The secondary objectives are to measure the tumor response by modified RECIST and to evaluate the formation of anti-AB0024 antibodies.

Patients will receive infusions of AB0024 every two weeks. Patients will be seen weekly for safety assessments and collection of blood samples. Patients who do not show evidence of disease progression by clinical assessment or by CT or MRI may continue receiving AB0024 every 2 weeks until disease progression (clinical or radiographic), study drug intolerance, or withdrawal of consent.

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323933

Locations
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Patricia LoRusso, DO Karmanos Cancer Institute
Principal Investigator: Anthony Tolcher, MD South Texas Accelerated Research Therapeutics
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Zung Thai, MD/ Medical Monitor, Gilead Sciences
ClinicalTrials.gov Identifier: NCT01323933     History of Changes
Obsolete Identifiers: NCT01158872
Other Study ID Numbers: AB0024-101
Study First Received: March 24, 2011
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Solid tumors
Oncology
Cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013