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ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas

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ClinicalTrials.gov Identifier: NCT02264613
Recruitment Status : Unknown
Verified June 2017 by Aileron Therapeutics.
Recruitment status was:  Recruiting
First Posted : October 15, 2014
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Aileron Therapeutics

Brief Summary:
This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with WT TP53.

Condition or disease Intervention/treatment Phase
Solid Tumor Lymphoma Peripheral T-Cell Lymphoma Drug: ALRN-6924 Phase 1 Phase 2

Detailed Description:

Open label, multi-center dose escalation (DEP) and dose expansion (EXP) study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with wild-type (WT) TP53. ALRN-6924 is a stapled peptide designed to disrupt integration between the p53 tumor suppression protein and inhibition by murine double minute 2 (MDM2) and murine double minute X (MDMX).

The DEP portion of the study will enroll adults with histologically- or cytologically-confirmed malignancies that are metastatic or unresectable and for which standard treatment(s) are not available or are no longer effective can be enrolled.The EXP portion of the study will enroll distinct groups of patients with specific solid tumors and/or lymphomas to further investigate the clinical safety profile and potential efficacy of ALRN 6924 at the MTD or OBD. PTCL has been selected as one of the EXP groups to be further studied.

Treatment of patients in the DEP and EXP phases will continue in the study until documentation of disease progression, unacceptable toxicity, or patient or physician decision to discontinue study participation is made.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas Expressing Wild-Type p53 Protein
Actual Study Start Date : October 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Dose Regimen A (DR-A)
Fixed dose of ALRN-6924 per cohort, administered IV, Days 1, 8, and 15 every 28 days
Drug: ALRN-6924
ALRN-6924 will be administered as an IV infusion

Experimental: Dose Regimen B (DR-B)
Fixed dose of ALRN-6924 per cohort, administered IV, Days 1, 4, 8 and 11 every 21 days
Drug: ALRN-6924
ALRN-6924 will be administered as an IV infusion




Primary Outcome Measures :
  1. Determine maximum tolerated dose (MTD) - DEP Phase [ Time Frame: From first dose up to 30 days after last dose ]
  2. Determine Overall Response Rate - EXP Phase [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Pharmacokinetics of ALRN-6924: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 2 months ]
  2. Pharmacokinetics of ALRN-6924: Maximum plasma concentration (Cmax) [ Time Frame: 2 months ]
  3. Pharmacokinetics of ALRN-6924: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 2 months ]
  4. Pharmacokinetics of ALRN-6924: Half-life (t1/2) [ Time Frame: 2 months ]
  5. RECIST (Response Evaluation Criteria in Solid Tumors): primary tumor [ Time Frame: 2 months ]
    Imaging of primary solid tumor site

  6. International Working Group response criteria: primary tumor (lymphoma patients) [ Time Frame: 2 months ]
    The International Working Group criteria is used to define and measure response in lymphoma patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Male or female patients age 18 years and older, inclusive, at the time of informed consent
  • Histologically- or cytologically-confirmed malignancy that is metastatic or unresectable and for which standard measures do not exist or are no longer effective (DEP) or a histologically confirmed diagnosis of PTCL based on pathology review at the local institution, using the most recent edition of the WHO Classification, relapsed or refractory disease after at least one prior systemic anticancer regimen (EXP in PTCL)
  • WT TP53 status
  • At least one target lesion that is measurable by RECIST 1.1 for solid tumors, or IWG 2014 for lymphoma
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-1
  • Adequate hematologic function
  • Adequate hepatic function
  • Acceptable coagulation profile
  • Recovery from significant toxicities from previous therapies and sufficient time since last dose of previous therapy

Exclusion Criteria:

  • Previous treatment with investigational agents that inhibit MDM2 or MDMX activity (some MDM2-treated patients may be eligible)
  • Known hypersensitivity to any study drug component
  • Known and untreated brain metastases. Patients with primary CNS (central nervous system) malignancies are excluded.
  • History of coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
  • History of pulmonary embolism within 6 months prior to the first dose of ALRN-6924 or untreated DVT (deep vein thrombosis)
  • Required concurrent use of anti-coagulants or anti-platelet medication, with the exception of aspirin doses ≤81 mg/day, low-dose SC heparin or SC low-molecular-weight heparin for DVT prophylaxis, or heparin flushes to maintain IV catheter patency
  • Patients with pre-existing history of or known cardiovascular risk
  • Clinically significant gastrointestinal bleeding within 6 months prior to the first dose of ALRN-6924
  • Clinically significant third-space fluid accumulation
  • Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C
  • Patients with cancers likely to be Human Papilloma Virus (HPV)-positive such as cervical cancers, oropharyngeal cancers or anal cancers must undergo additional screening to determine eligibility
  • Known history of another primary malignancy that has not been in remission for ≥2 years
  • Required use of medications predominantly cleared by hepatobiliary transporters within 48 hours of study drug infusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264613


Contacts
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Contact: Marie Payton mpayton@aileronrx.com

Locations
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United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Dayle Craig    205-975-8080    Dc0350@uab.edu   
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Linda Lee, CRN    626-218-9165    linlee@coh.org   
United States, Colorado
Sarah Cannon Research Institution - HealthONE Recruiting
Denver, Colorado, United States, 80218
Contact: Lori Hannan    720-754-2610    Lori.Hannan@healthonecares.com   
United States, Florida
Sarah Cannon Research Institution - Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
Contact: Heather Rieth    941-377-9993    hrieth@flcancer.com   
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Nicole Rozario    813-745-4725    Nicole.Rozario@Moffitt.org   
United States, Massachusetts
The Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Brian Beardslee, RN,MSN    617-632-5638    brian_beardslee@dfci.harvard.edu   
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Veenna Minnal       minnalv@mskcc.org   
Montefiore Einstein Center for Cancer Care Recruiting
The Bronx, New York, United States, 10461
Contact: Mohammad H. Ghalib, MBBS    718-405-8515    mhghalib@montefiore.org   
United States, South Carolina
Institute for Translational Oncology Research (ITOR) Recruiting
Greenville, South Carolina, United States, 29605
Contact: Lisa Johnson    864-455-3600    ljohnson4@ghs.org   
United States, Tennessee
Sarah Cannon Research Institution Recruiting
Nashville, Tennessee, United States, 37203
Contact: Caitlon Jacoby    615-524-4455    Caitlon.Jacoby@scresearch.com   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Krystle A Luna    713-563-2690    KALuna@mdanderson.org   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Lara Schiff    206-288-6787    ashustov@u.washington.edu   
Sponsors and Collaborators
Aileron Therapeutics
Investigators
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Study Director: Dawn Pinchasik, M.D. Aileron Therapeutics

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Responsible Party: Aileron Therapeutics
ClinicalTrials.gov Identifier: NCT02264613     History of Changes
Other Study ID Numbers: ALRN-6924-1-01
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin