A Phase 1 Trial of ABI-011 in Patients With Advanced Solid Tumors or Lymphomas

NCT01163071 | Terminated Phase 1

• 1 other identifier: CA601
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the MTD and/or RP2D of ABI-011 when administered by IV on Day 1, Day 8 and Day 15 with one week of rest for patients with advanced solid tumor malignancies and lymphomas.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• DLT's and MTD Safety and Toxicity profile

  Evaluate PK and PD of ABI-011. Preliminary assessment of tumor response.

  During Cycle 1, treatment period, End of Study and Follow-Up, approximately up to 2 years

Secondary Outcomes (5)

• Safety and toxicity profile of repeated dosing of ABI-011

  End of study and follow up, approximately up to 2 years

• Evaluate plasma PK of ABI-011 on this schedule

  End of Study and follow-up, Up to two years

• Assess biological activity and PD of ABI-011

  End of study and follow-up, approximately 2 years

• Make preliminary assessment of tumor response

  End of study and follow-up, approximately 2 years

• Assess biological activity/exploratory during treatment C1, C2, EOS

  End of Study and follow-up, aproximately two years

Study Arms (1)

ABI-011

EXPERIMENTAL

Drug: ABI-011

Interventions

ABI-011 DRUG

ABI-011

ABI-011

Eligibility Criteria

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

You may qualify if:

• Must be equal or greater 18 years of age
• ECOG performance status less than or equal to 2 (Appendix 2)
• Pts. must be willing and able to sign informed consent
• Cytologically or histologically confirmed solid tumor malignancy or lymphoma for which no standard approved therapy is available. Patients should have accessible tumor lesions amendable to 2 serial biopsies which would not put the patient or their treatment at risk
• Pt. agrees and is willing to provide 2 serial tumor biopsies(optional on first phase, mandatory on 2nd phase)
• During the dose escalation phase, measurable or non-measurable disease as defined by RECIST criteria. At 2nd phase, only patients with measurable disease
• Life expectancy of equal or greater than 12 weeks
• All AEs of any prior chemotherapy, surgery or radiotherapy, must have resolved to grade equal to or less than 1
• The following laboratory results must be present within 14 days of initial ABI-011 administration
• Hemoglobin greater or equal to 9g/dL
• Absolute neutrophils count(ANC)greater or equal to 1.5 x 10\^9/L
• Platelet count is greater or equal to 100 x 10\^9/L
• Serum bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
• Aspartate transaminase (AST) and alanine transaminase (ALT)is less than or equal to 2.5 ULN(except if liver metastases are present; then values must be less than or equal to 5 x ULN)
• Potassium, corrected calcium and magnesium WNL

You may not qualify if:

• Inability to comply with study and follow-up procedures
• Women who are pregnant or lactating
• Treatment with chemotherapy, hormonal therapy(except leuprolide for prostate cancer), immunotherapy, biologic therapy, or radiation therapy as cancer therapy within 4 weeks before initiation of study treatment. Six weeks should have elapsed if prior chemotherapy treatment included nitrosoureas or mitomycin C
• Pts. who have received antibody-based therapies within 28 days or 5 half-lives of the agent, whichever time period is longer
• Major surgery within 6 weeks before first study drug administration
• Prior treatment with tumor vascular disruptive agents
• Any uncontrolled medical or psychiatric risk factors
• Central nervous system(CNS)metastases.
• History of diabetic retinopathy. All patients must be evaluated by an ophthalmologist prior to study treatment
• Any history of myopathy, either peripheral or cardiac
• Current use of medications that may have the potential of QTc prolongation
• History of allergy or hypersensitivity to any compound of the ABI-011 formulation
• Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
• Pt.has known infection with human immunodeficiency virus (HIV),or known chronic Hepatitis B or Hepatitis C
• Inability to be venipunctured and/or tolerate venous access

Sponsors & Collaborators

• Celgene: lead
• Celgene Corporation: collaborator

Study Sites (2)

Karmanos Cancer Center Institute

Detroit, Michigan, 48201, United States

Location

CTRC @ The Utah Health Science Center @ San Antonio

San Antonio, Texas, 78229, United States

Location

Study Officials

• Patricia M LoRusso, DO

  Karmanos Cancer Institute Hudson-Webber Cancer Research Center

  PRINCIPAL INVESTIGATOR

• John Sarantopoulos, MD

  Cancer Therapy Research Center at the University Health Sciences Center at San Antonio

  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: June 15, 2010
• First Posted: July 15, 2010
• Study Start: March 1, 2011
• Primary Completion: September 23, 2011
• Study Completion: September 23, 2011
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

US (2)