Safety/Tolerability Study of AV-412 in Subjects With Refractory or Relapsed Solid Tumor Malignancies

NCT00381654 | Terminated Phase 1

• 1 other identifier: AV-412-06-101
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 3

Brief Summary

AV-412 is a new oral therapy developed to inhibit the growth of solid tumors in patients who have not responded to standard therapy or surgical interventions, or who have experienced relapse. This study will test the safety of AV-412 and determine the maximum tolerated dose for the treatment of solid tumors.

Conditions

Tumor

Keywords

Solid Tumors; Tyrosine Kinases

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety, tolerability, and dose-limiting toxicities (DLT), and determine the maximum tolerated dose (MTD) of AV-412 when administered once daily by the oral route for 4 weeks (4 weeks equals one dosing cycle)

  one year

Secondary Outcomes (3)

• To characterize the pharmacokinetic (PK) profile of AV-412 in all patients. Extensive PK collection and assay to be performed in expanded MTD Cohorts

  18 months

• Evaluate potential pharmacodynamic (PD) markers of AV-412 action, in expanded MTD Cohorts ONLY

  two years

• Preliminary evaluation of the antineoplastic activity of AV-412 (assessed by evidence and duration of disease stabilization or objective response, and time to disease progression)

  two years

Study Arms (1)

A

EXPERIMENTAL

Daily oral administration of AV-412

Drug: AV-412

Interventions

AV-412 DRUG

Solid oral dosage; 4 dosage strengths; 25, 50, 100, or 200 mg per capsule Dosing Frequency: Once daily dosing for 4 weeks (4 weeks equals 1 cycle)

A

Eligibility Criteria

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

You may qualify if:

• ≥ 18 year old males or females
• Documented measurable or evaluable solid tumor malignancy that is relapsed, refractory, locally advanced, or metastatic
• Patients entered to MTD Cohort B must have:
• Histologically or cytologically confirmed NSCLC
• No prior therapy with erlotinib, gefitinib, or any other EGFR-kinase inhibitor
• Previously documented exon 19 deletion and/or exon 21 L858R mutations
• Measurable disease according to RECIST
• Disease that is currently refractory to, or not amenable to, standard therapy
• Disease that is currently not amenable to surgical intervention, due to either medical contraindications or nonresectability of the tumor
• Karnofsky performance status ≥ 70%, life expectancy ≥ 3 months
• No childbearing potential or use of effective contraception by all fertile male and female patients, during the study and for 3 months after the last dose of study drug
• Ability to give written informed consent

You may not qualify if:

• Pregnant or lactating women
• Primary CNS malignancies; active CNS metastases
• Hematologic malignancies (includes: leukemia, any form; lymphoma; and multiple myeloma)
• Active second malignancy or history of another malignancy within 2 years with the exception of:
• Treated, non-melanoma skin cancers
• Treated CIS of the breast or cervix
• Controlled, superficial bladder carcinoma
• T1a or b prostate carcinoma involving \< 5% of resected tissue and PSA within normal limits (WNL)
• Any of the following hematologic abnormalities:
• Hemoglobin ≤ 9.0 g/dL
• ANC \< 1,500 per mm3
• Platelet count \< 100,000 per mm3
• Any of the following serum chemistry abnormalities:
• Total bilirubin \> 1.5 × the ULN
• AST or ALT ≥ 3 × the ULN (≥ 5 × if due to hepatic involvement by tumor)

Sponsors & Collaborators

• AVEO Pharmaceuticals, Inc.: lead

Study Sites (3)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Hospital Universitatrio Austral

Buenos Aires, Argentina

Location

Instituto Médico Especializado Alexander Fleming

Buenos Aires, Argentina

Location

Related Links

• Aveo Pharmaceutical, Inc home page

MeSH Terms

Conditions

Neoplasms

Interventions

MP 412

Study Officials

• Manuel Hidalgo, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Justina L Martinez, MD

  Hospital Universitatrio Austral

  PRINCIPAL INVESTIGATOR

• Carmen S. Puparelli, MD

  Instituto Médico Especializado Alexander Fleming

  PRINCIPAL INVESTIGATOR

• Belén R. Viquiera, M.D.

  Centro Integral Oncológica Clara Campal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 28, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: October 4, 2011

Record last verified: 2011-09

Locations

US (1); AR (2)