Moffitt logo

COVID-19 Update: See the latest on our visitor policy here. Learn More

Clinical Trials Search

Clinical Trial 21160

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04022876

Phase: Phase I/II
Principal Investigator: Chiappori, Alberto

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

A Phase 1b/2 Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, for the Prevention of Chemotherapy-induced Myelosuppression

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 chemotherapy-induced side effects in patients with p53-mutated ED SCLC undergoing 2nd-line treatment with topotecan. (Part 1 has completed enrollment). Part 2 NSCLC is a randomized, double-blind, placebo-controlled, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated advanced NSCLC of adenocarcinoma histology receiving 1st-line treatment with carboplatin plus pemetrexed with or without immunotherapy.

Objective

Part 1 (SCLC) - Phase 1b, primary: To evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) and schedule of ALRN-6924 when administered to patients with TP53-mutated ED SCLC receiving topotecan as 2nd-line treatment Part 1 (SCLC) Phase 2, primary: To evaluate the myelopreservation effects of ALRN-6924 when administered at the RP2D and schedule to patients with TP53-mutated ED SCLC undergoing 2nd-line treatment with topotecan Part 2 (NSCLC) - Phase 1b, primary: To evaluate the preliminary myelopreservation effects of ALRN-6924 when administered to patients with TP53-mutated advanced NSCLC of adenocarcinoma histology receiving 1st_line treatment with carboplatin plus pemetrexed with or without immunotherapy.

Treatments

Therapies

Medications

ALRN-6924 (); Alimta (Pemetrexed); Paraplatin (carboplatin); Pemetrexed (); Placebo (); carboplatin ()

Inclusion Criteria

Phase 1b, Part 2 NSCLC Inclusion Criteria:

  • 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 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.

  • Exclusion Criteria

    Phase 1b, Part 2 NSCLC Exclusion Criteria:

  • 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 Exclusion Criteria:
  • More than one line of prior chemotherapy for ED SCLC (prior immunotherapy is permitted, concurrent with or subsequent to first line chemotherapy).
  • Presence of active central nervous system metastases and/or carcinomatous meningitis.
  • Significant weight loss (≥15% body weight) within the 4 weeks prior to enrollment.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.