AL102 for Desmoid Tumors

Phase-Based Progress Estimates

1

Effectiveness

2

Safety

Desmoid Tumors+1 MoreAL102 - Drug

You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.

Eligibility

Any Age

All Sexes

What conditions do you have?

Select

Eligibility

Any Age

All Sexes

What conditions do you have?

Select

Study Summary

This trial will test if a new drug, AL102, is safe and effective in treating patients with desmoid tumors.

Eligible Conditions

Desmoid Tumors
Desmoid Tumor

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Approximately 2 years

Approximately 2 years

Duration of response

Overall response rate

Patient reported outcome

Progression free survival

Trial Safety

Safety Progress

2 of 3

This is further along than 68% of similar trials

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1

FF-10850 Topotecan Liposome Injection

1

FF-10832 Gemcitabine Liposome Injection

Trial Design

6 Treatment Groups

Part A Main Study 1.2 mg daily

1 of 6

Part A Main Study 2 mg Intermittent

1 of 6

Part A Main Study 4 mg Intermittent

1 of 6

Part B AL102

1 of 6

Open Label Extension

1 of 6

Part B Placebo

1 of 6

Experimental Treatment

Non-Treatment Group

192 Total Participants · 6 Treatment Groups

Primary Treatment: AL102 · Has Placebo Group · Phase 2 & 3

Part A Main Study 1.2 mg daily

Drug

Experimental Group · 1 Intervention: AL102 · Intervention Types: Drug

Part A Main Study 2 mg Intermittent

Drug

Experimental Group · 1 Intervention: AL102 · Intervention Types: Drug

Part A Main Study 4 mg Intermittent

Drug

Experimental Group · 1 Intervention: AL102 · Intervention Types: Drug

Part B AL102

Drug

Experimental Group · 1 Intervention: AL102 · Intervention Types: Drug

Open Label Extension

Drug

Experimental Group · 1 Intervention: AL102 · Intervention Types: Drug

Part B Placebo

Other

PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: approximately 2 years

Who is running the clinical trial?

Ayala Pharmaceuticals, Inc,Lead Sponsor

3 Previous Clinical Trials

214 Total Patients Enrolled

Mrinal Gounder, MDPrincipal InvestigatorMSKCC

2 Previous Clinical Trials

429 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

You have a histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist.

You have at least 1 measurable lesion amenable to volume measurements by MRI at screening (Part A only).

You have pain that is not adequately controlled with nonopioid medication.

You are able to swallow capsules whole without a GI condition affecting absorption

References

2021. "A Study of AL102 in Patients With Progressing Desmoid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04871282.

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