AFP464 in Treating Patients With Advanced Solid Tumors

NCT00369200 | Terminated Phase 1

• 5 other identifiers: NCI-2009-00163CDR00004920062006-0117378U01CA062487
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is studying the side effects and best dose of AFP464 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as AFP464, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose determined by dose-limiting toxicity

  28 days

• Types and grades of toxicity

  Full frequency distributions of grade of toxicity, by toxicity type, will be generated, by dose level. Among all treated patients, both point and exact confidence interval estimates of the rate of every specific type of Grade 3-4 toxicity will be calculated, by dose level. Grade 2 DLCO rates (point and confidence level) will also be computed, by dose level.

  Up to 4 weeks

Secondary Outcomes (2)

• Pharmacokinetic, pharmacodynamic, and pharmacogenomic parameters

  Up to 4 weeks

• Response rate

  Up to 4 weeks

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive AFP464 IV over 3 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 2-6 patients receive escalating doses of AFP464 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which ≤ 1 of 6 patients experience dose-limiting toxicity. An additional 10 patients whose tumor is amenable to biopsy are treated at the MTD. Patients undergo blood collection periodically for pharmacokinetic and pharmacodynamic studies. Patients treated at the MTD also undergo tumor tissue biopsies periodically for additional pharmacodynamic and correlative biomarker studies. After completion of study treatment, patients are followed for 4 weeks.

Drug: AFP464; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

AFP464 DRUG

Given IV

Arm I

laboratory biomarker analysis OTHER

Correlative study

Arm I

pharmacological study OTHER

Correlative study

Also known as: pharmacological studies

Arm I

Eligibility Criteria

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

You may qualify if:

• Bilirubin normal
• Platelet count \>= 100,000/mm³
• AST and ALT =\< 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance \>= 60 mL/min
• Adequate pulmonary function
• DLCO =\< grade 1
• No symptomatic pulmonary disease
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Negative pregnancy test
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to AFP464
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Study Officials

• Patricia LoRusso

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2011
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

US (1)