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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323933
• Other study ID #: AB0024-101
• Status: Completed
• Phase: Phase 1
• First received: March 24, 2011
• Last updated: May 2, 2012
• Start date: June 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT01158872

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• AB0024
Comparison of different dosages of drug

Locations

Country	Name	City	State
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the safety, tolerability, and pharmacokinetics (PK) of AB0024 after multiple intravenous (IV) administrations in patients with advanced solid tumors.		Day 71	Yes
Secondary	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	Yes