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QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

NCT01029873 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-10-27

No results posted yet for this study

Summary

This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have metastatic melanoma that is considered surgically incurable. The anti-tumor responses of ALT-801 with cisplatin will also be assessed in this trial.

Conditions

Interventions

DRUG

Cisplatin

Intravenous infusions; 2 treatment courses; 2 treatment cycles for each course; 70mg/m2 on day 1 of cycle 1 for each course

BIOLOGICAL

ALT-801

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses Stage 1: dose escalation (0.04 mg/kg, 0.06 mg/kg, 0.08 mg/kg) Stage 2: dose expansion (dose at MTD)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Altor BioScience

    lead INDUSTRY

Principal Investigators

  • Hing Wong, PhD · Altor BioScience

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-11-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01029873 on ClinicalTrials.gov