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Inhibitor

ASTX660 for Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Astex Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with histologically or cytologically confirmed advanced solid tumors or lymphoma that is metastatic or unresectable, and for whom standard life-prolonging measures are not available. Specific tumor types that will be selected for study in Phase 2 are detailed in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 84 months
Awards & highlights

Study Summary

This trial is testing a new drug, ASTX660, to see if it is safe and works well against cancer.

Who is the study for?
Adults with advanced solid tumors or lymphoma that can't be removed by surgery and have no standard life-prolonging treatments available. They must have acceptable organ function, not be pregnant or breastfeeding, agree to use effective contraception, and not have other serious health issues that could affect their safety or the study results.Check my eligibility
What is being tested?
ASTX660 is being tested in this Phase 1/2 trial to find the safest dose, see how well it works against certain cancers, and understand its effects on the body. Participants will receive ASTX660 directly without comparison to another drug.See study design
What are the potential side effects?
Specific side effects of ASTX660 are not listed but may include typical reactions seen with cancer drugs such as fatigue, nausea, risk of infection due to low blood counts, potential liver or kidney issues reflected by lab tests requirements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced, cannot be surgically removed, and has no standard treatment options.
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I can take care of myself and am up and about more than half of my waking hours.
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My organ functions are within normal ranges according to recent tests.
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My cancer is a specific type of lymphoma recognized by the WHO.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 84 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 84 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy (Phase 2) - antitumor activity assessed by disease control rate (DCR)
Efficacy (Phase 2) - antitumor activity assessed by objective response rate (ORR)
Safety (Phase 1) - number of subjects with AEs, DLTs, abnormal clinical laboratory values or physical exam results
Secondary outcome measures
Assessment of target (cIAP1) engagement
Duration of antitumor response
Overall survival
+7 more

Trial Design

9Treatment groups
Experimental Treatment
Group I: Phase 2 - Cohort 6Experimental Treatment1 Intervention
Treatment with ASTX660 for cervical carcinoma not responsive or relapsed after standard therapy.
Group II: Phase 2 - Cohort 5Experimental Treatment1 Intervention
Treatment with ASTX660 for other tumor types that are characterized by a molecular feature that may confer sensitivity to ASTX660 (eg, oncogenic activation of the NF-κB pathway or documented amplification of the gene loci encoding c-IAP1 or c-IAP2), pending confirmation in writing by the Astex medical monitor.
Group III: Phase 2 - Cohort 4Experimental Treatment1 Intervention
Treatment with ASTX660 for relapsed or refractory cutaneous T-cell lymphoma (CTCL).
Group IV: Phase 2 - Cohort 3Experimental Treatment1 Intervention
Treatment with ASTX660 for progressive or relapsed peripheral T-cell lymphoma (PTCL).
Group V: Phase 2 - Cohort 2Experimental Treatment1 Intervention
Treatment with ASTX660 for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Group VI: Phase 2 - Cohort 1Experimental Treatment1 Intervention
Treatment with ASTX660 for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) not responsive or relapsed after standard therapy.
Group VII: Phase 1 - Part 3 (optional)Experimental Treatment1 Intervention
The purpose of the optional Part 3 is to allow for exploration of an alternative dosing regimen of ASTX660 based on emerging safety, PK, and pharmacodynamic (PD) data from Parts 1 and 2 (using the original every-other-week dosing regimen), with agreement of the DSRC. If Part 3 is conducted, the plan is to enroll up to 18 evaluable subjects in 1 or more cohorts using a standard 3+3 study design.
Group VIII: Phase 1 - Part 2 (completed)Experimental Treatment1 Intervention
Dose-expansion stage to confirm tolerability of ASTX660 at the RP2D using the every-other-week daily dosing regimen. Up to a total of 12 subjects (including the 3 or 6 subjects treated at the RP2D in Part 1) will be treated at the RP2D.
Group IX: Phase 1 - Part 1 (completed)Experimental Treatment1 Intervention
Dose-escalation stage to identify the MTD and the RP2D, defined as either the MTD or a dose below the MTD that the Data and Safety Review Committee (DSRC) agree shows adequate pharmacological evidence of target engagement and/or clinical activity. Subjects will receive ASTX660 once a day for 7 consecutive days every other week of each 28-day cycle (ie, [7 days on/ 7 days off] ×2; daily dosing on Days 1-7 and 15-21). The starting dose will be escalated stepwise in successive cohorts of 3 to 6 evaluable subjects each (standard 3+3 study design), until the RP2D is determined.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASTX660
2020
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,735 Total Patients Enrolled
10 Trials studying Lymphoma
624 Patients Enrolled for Lymphoma
Jason Taylor, MD, PhDStudy DirectorAstex Pharmaceuticals, Inc.
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

ASTX660 (Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02503423 — Phase 1 & 2
Lymphoma Research Study Groups: Phase 2 - Cohort 3, Phase 2 - Cohort 5, Phase 1 - Part 1 (completed), Phase 1 - Part 3 (optional), Phase 2 - Cohort 1, Phase 1 - Part 2 (completed), Phase 2 - Cohort 2, Phase 2 - Cohort 4, Phase 2 - Cohort 6
Lymphoma Clinical Trial 2023: ASTX660 Highlights & Side Effects. Trial Name: NCT02503423 — Phase 1 & 2
ASTX660 (Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02503423 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment capacity of this trial?

"This research trial has ceased recruitment as of November 18th 2022. It was initially posted on July 1st 2015 and is no longer accepting any more participants. However, for those looking for other trials related to lymphoma there are presently 2136 studies recruiting patients. Additionally, 3 clinical trials are currently enrolling individuals with ASTX660."

Answered by AI

Is this research a pioneering effort for its field?

"To date, ASTX660 has been subject to 3 clinical trials in 43 cities and 9 countries. The earliest of these began in 2015 under the patronage of Astex Pharmaceuticals Inc., with 230 participants taking part over two stages. Since then, two further studies have concluded."

Answered by AI

Are there any openings for volunteers to join this clinical trial?

"Clinicaltrials.gov states that this particular trial is no longer accepting patients, which was the case since its posting on July 1st 2015 and most recent update of November 18th 2022. However, there are 2139 other trials available for enrollment at this time."

Answered by AI

What earlier research has been conducted utilizing ASTX660?

"In 2015, ASTX660 was initially investigated at Cancer Care Manitoba. Subsequently, there were two completed trials and presently three studies are seeking participants with a large proportion of them occurring in Oklahoma City."

Answered by AI

How many medical institutions are administering this research experiment?

"This trial has been rolled out in 32 different sites, with notable locations such as the University of Oklahoma Stephenson Cancer Center located in Oklahoma City, University of Washington, Seattle Cancer Care Alliance based in Seattle, and Tom Baker Cancer Centre situated in Calgary."

Answered by AI

What is the goal of this experiment?

"According to the trial sponsor, Astex Pharmaceuticals Inc., this evaluation aims to measure Efficacy (Phase 2) - antitumor activity assessed by disease control rate (DCR) during a period of up to 78 months. Secondary parameters such as Pharmacokinetic outcome of time to maximum concentration (Tmax), and assessment of ASTX660 metabolites if applicable, in addition to other secondary PK parameters will also be monitored."

Answered by AI
~12 spots leftby Oct 2024