AT7519M in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory Non-Hodgkin's Lymphoma

Phase 1

Completed

• Conditions: Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: CDKI AT7519; Other: laboratory biomarker analysis

• Registration Number: NCT00390117
• Lead Sponsor: NCIC Clinical Trials Group

Brief Summary

RATIONALE: AT7519M may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of AT7519M in treating patients with advanced or metastatic solid tumors or refractory non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

Primary

* Determine the recommended phase II dose of AT7519M in patients with advanced or metastatic solid tumors or refractory non-Hodgkin's lymphoma.

* Determine the safety, tolerability, toxicity profile, and dose-limiting toxicities of this drug in these patients.

* Determine the pharmacokinetic profile of this drug in these patients.

* Correlate the toxicity profile with pharmacokinetics of this drug in these patients.

Secondary

* Assess, preliminarily, the antitumor activity of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive AT7519M IV over 1-3 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of AT7519M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during course 1. Once the MTD has been determined, up to 8 additional patients are treated at the MTD.

Patients undergo blood collection periodically for pharmacokinetic studies. Patients treated at the MTD also undergo tumor tissue biopsies or aspirates and blood collection periodically for additional pharmacodynamic and correlative biomarker studies.

After completion of study therapy, patients are followed at 4 weeks. Patients with complete response, partial response, or stable disease are followed every 3 months thereafter until relapse.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Timeline

• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Study Start: 2007-01-05
• Primary Completion: 2012-03-13
• Study Completion: 2013-01-10
• Status Verified: 2020-04
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CDKI AT7519	CDKI AT7519	AT7519M (1 hour IV) on days 1, 4, 8 and 11 every 5 weeks.
CDKI AT7519	laboratory biomarker analysis	AT7519M (1 hour IV) on days 1, 4, 8 and 11 every 5 weeks.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose as assessed by NCI CTCAE v.30	from time of 1st dose
Safety, tolerability, toxicity profile, and dose-limiting toxicities as assessed by NCI CTCAE v.30	from time of 1st dose
Pharmacokinetic profile as measured on days 1, 2, and 4 in course 1	one month	during cycle 1
Correlation of toxicity profile with pharmacokinetics	after completion of each dose level

Secondary Outcome Measures

Name	Time	Method
Preliminary antitumor activity of treatment in patients with measurable disease	Every 60 days	after every second cycle
Response duration (median and range)	after progression
Overall response (complete and partial response) rate	Every 60 days	after every second cycle

Trial Locations

Locations (2)

Univ. Health Network-Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Juravinski Cancer Centre at Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada