Status:
TERMINATED
A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)
Lead Sponsor:
Aileron Therapeutics, Inc.
Conditions:
Non Small Cell Lung Cancer
Small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1b, multicenter, 2-part study of ALRN-6924 for the prevention of chemotherapy-induced side effects. Part 1 SCLC is an open-label, multicenter study of ALRN-6924 for the prevention of ...
Detailed Description
During Part 1 SCLC, topotecan will be administered per standard practice on Days 1-5 of 21-day cycles. Patients will be randomized to receive 1 of 2 initial ALRN-6924 dose levels, to be administered p...
Eligibility Criteria
Inclusion
- Phase 1b, Part 2 NSCLC
- Histopathological confirmation of Stage IV NSCLC of adenocarcinoma histology. Cytological diagnosis of NSCLC is acceptable if sufficient tumor tissue is available for p53 mutation analysis. FDA approved liquid biopsies are also acceptable.
- Presence of one or more p53 mutations.
- Measurable disease using RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Adequate hematological status.
- Adequate hepatic and renal function.
- Phase 1b, Part 2 NSCLC
Exclusion
- Advanced NSCLC tumors with EGFR mutations or ALK re-arrangement or other actionable genetic aberrations for which an approved targeted treatment is available. Patients who received prior treatment with EGFR or ALK inhibitors or other systemic drugs or immunotherapy for NSCLC are not eligible.
- Patients who are candidates for anti-PD-1 monotherapy in 1st line advanced NSCLC (e.g. tumors with high PD-L1 expression).
- Presence of active central nervous system metastases and/or carcinomatous meningitis.
- Significant weight loss (≥15% body weight) within the 4 weeks prior to enrollment.
- Phase 1b, Part 1 SCLC Inclusion Criteria:
- Histopathological confirmation of ED SCLC that has recurred or been refractory to one line of treatment with standard platinum-based chemotherapy or immuno-chemotherapy. Patients who received immunotherapy after platinum-based chemotherapy are eligible.
- Presence of one or more p53 mutations.
- Measurable disease using RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Adequate hematological status.
- Adequate hepatic and renal function.
- Phase 1b, Part 1 SCLC
Key Trial Info
Start Date :
September 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04022876
Start Date
September 3 2019
End Date
August 30 2022
Last Update
October 10 2022
Active Locations (28)
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1
Arizona Cancer Center
Kingman, Arizona, United States, 86409
2
Mount Sinai Cancer Research Program
Miami, Florida, United States, 33140
3
Oncology & Hematology Associates of West Broward
Tamarac, Florida, United States, 33321
4
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612