AL102 for Desmoid Tumors

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Desmoid Tumors+1 MoreAL102 - Drug
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

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

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