← Back to Search

PARP Inhibitor

2X-121 + Dovitinib for Cancer

Phase 1
Recruiting
Research Sponsored by Allarity Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically documented solid tumor
Performance status of ECOG ≤ 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated after up to approximately 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see how well it works and what side effects it has.

Who is the study for?
Adults with advanced solid tumors who have recovered from previous treatments, have a life expectancy of at least 3 months, and meet certain blood and organ function criteria. They must not be on other cancer therapies or have active infections or significant heart issues. Participants need to agree to use contraception and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is in two parts: first, finding the highest dose of 2X-121 that patients can tolerate without severe side effects (monotherapy), then determining the maximum tolerated dose of dovitinib combined with 2X-121. It will assess safety, how the body processes these drugs, and their effectiveness against tumors.See study design
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to cancer medications such as nausea, fatigue, blood count changes, liver function alterations, and possibly others depending on individual tolerance levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer was confirmed through tissue or cell testing.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated after up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated after up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of the MTD of 2X-121 monotherapy.
Determination of the MTD of dovitinib given in combination with 2X-121 (MTD).
Secondary outcome measures
To evaluate overall survival (OS) of 2X-121 monotherapy (Part 1) and in combination with dovitinib (Part 2).
To evaluate progression free survival (PFS) of 2X-121 monotherapy (Part 1) and in combination with dovitinib (Part 2).
To evaluate the duration of overall response (DOR) of 2X-121 monotherapy (Part 1) and in combination with dovitinib (Part 2).
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: 2X-121 Monotherapy and Dovitinib in Combination with 2X-121 in Patients with Advanced Solid TumorsExperimental Treatment1 Intervention
Determine the maximum tolerated dose (MTD) of 2X-121 monotherapy given twice daily (BID) and determine the MTD of dovitinib given in combination with 2X-121 (MTD) in patients with advanced solid tumors.

Find a Location

Who is running the clinical trial?

Allarity TherapeuticsLead Sponsor
7 Previous Clinical Trials
288 Total Patients Enrolled
Amarex Clinical ResearchOTHER
26 Previous Clinical Trials
1,642 Total Patients Enrolled

Media Library

2X-121 (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05571969 — Phase 1
Solid Tumors Research Study Groups: 2X-121 Monotherapy and Dovitinib in Combination with 2X-121 in Patients with Advanced Solid Tumors
Solid Tumors Clinical Trial 2023: 2X-121 Highlights & Side Effects. Trial Name: NCT05571969 — Phase 1
2X-121 (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05571969 — Phase 1

Frequently Asked Questions

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

Are there still patient vacancies available for this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was originally posted on October 20th 2022, is still in the process of enlisting participants. Approximately 40 individuals are required to be recruited from 2 distinct medical facilities."

Answered by AI

What protective measures are taken to ensure the safety of patients when using 2X-121 Monotherapy and Dovitinib in Combination with 2X-121 for Advanced Solid Tumors?

"Due to a dearth of data assessing both safety and efficacy, 2X-121 Monotherapy and Dovitinib in Combination with 2X-121 received a score of 1."

Answered by AI

What are the chief goals of this medical study?

"The main purpose of this clinical trial, monitored for up to two years, is to determine the maximum tolerated dose (MTD) of dovitinib in combination with 2X-121. Secondary objectives include assessing overall survival from treatment date until death or last known living status; measuring duration of response between first documented complete/partial response and disease recurrence/progression; and calculating objective response rate by proportion of subjects who achieved a complete or partial response per RECIST v1.1 guidelines."

Answered by AI

What is the current enrollment capacity of this clinical trial?

"Confirmed. According to clinicaltrials.gov, the trial is still open for recruitment after being first advertised on October 20th 2022 and last updated 5 days ago. 40 participants are required from two separate medical centres."

Answered by AI
~13 spots leftby Oct 2024