Telaglenastat + Talazoparib In Prostate Cancer

NCT04824937 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 20-325
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to test the effectiveness of an experimental drug combination for people with metastatic castration-resistant prostate cancer (mCRPC). The names of the study drugs involved in this study are:

• Telaglenastat (CB-839)
• Talazoparib

Conditions

Prostate Cancer Metastatic

Keywords

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (6)

• Rate of objective responses

  Assessed by RECIST1.1

  Measured from the start of the treatment through study completion, an average of 1 year

• Rate of participants with clinical benefit

  Assessed by RECIST1.1

  Measured from the start of the treatment through study completion, an average of 1 year

• Rate of complete responses

  Assessed by RECIST1.1

  Measured from the start of the treatment through study completion, an average of 1 year

• Rate of partial responses

  Assessed by RECIST1.1

  Measured from the start of the treatment through study completion, an average of 1 year

• Rate of participants with progressive disease

  Assessed by RECIST1.1

  Measured from the start of the treatment through study completion, an average of 1 year

• Rate of participants with stable disease

  Assessed by RECIST1.1

  Measured from the start of the treatment through study completion, an average of 1 year

Secondary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0

  12 weeks

Study Arms (2)

Telaglenastat + Talazoparib

EXPERIMENTAL

During 28 day study cycles, participants will receive: * Telaglenastat 2x daily at a predetermined dose * Talazoparib 1x daily at a predetermined dose

Drug: Telaglenastat; Drug: Talazoparib

Telaglenastat + Talazoparib Staggered

EXPERIMENTAL

If a beneficial response is seen with the Arm 1 Telaglenastat + Talazoparib combination, participants will receive telaglenastat alone 2x daily at a predetermined dose with the addition of talazoparib at 1x daily at a predetermined dose if the disease gets worse.

Drug: Telaglenastat; Drug: Talazoparib

Interventions

Telaglenastat DRUG

Capsule, taken by mouth

Also known as: CB 839

Telaglenastat + Talazoparib; Telaglenastat + Talazoparib Staggered

Talazoparib DRUG

Capsule, taken by mouth

Also known as: Taken orally

Telaglenastat + Talazoparib; Telaglenastat + Talazoparib Staggered

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically or cytologically confirmed diagnosis adenocarcinoma of the prostate.
• Prostate cancer must be metastatic as confirmed by CT, PET scan, and/or bone scan.
• Prior biopsy of metastatic lesion (bone, lymph node, or visceral metastasis) with sufficient tissue for molecular analysis, or consent for a fresh biopsy for molecular analysis
• Participants must have tested negative for homologous recombination (HR) mutations (including known deleterious mutations in BRCA1, BRCA2, or ATM) on a blood-based or tissue-based assay
• History of bilateral orchiectomies or ongoing GnRH agonist or antagonist
• Castration-resistant disease based on progression per Prostate Cancer Working Group 2.21
• Prior treatment for metastatic prostate cancer with docetaxel and either abiraterone acetate or enzalutamide, OR ineligible for or declines treatment with docetaxel, abiraterone acetate, or enzalutamide.
• Adequate renal function with a serum creatinine ≤ 2.0 mg/dL or an estimated or calculated creatinine clearance of \> 50 mL/min (calculated using the formula of Cockcroft and Gault)
• Adequate hepatic function with total bilirubin ≤ 1.5x the upper limit of normal (ULN) and ALT and AST less than 3x the ULN.
• Adequate hematological function with ANC ≥ 1500/mm3, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100,000/mm3
• Age ≥ 18 years
• ECOG performance status of 0 or 1
• Ability to understand and the willingness to sign a written informed consent document
• Patients/participants with female partners of childbearing potential are eligible to participate if they agree to ONE of the following for the duration of the study:
• Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent for duration of the study.

You may not qualify if:

• Participants who have received more than two prior chemotherapy regimens for metastatic castration-resistant prostate cancer.
• Participants who have any previous treatment with PARP inhibitors
• Participants who are receiving any other investigational agents.
• Participants who have received radiation therapy within 2 weeks or radionuclide treatment within 6 weeks prior to registration on this study
• Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to telaglenastat or talazoparib
• Concurrent use of moderate or strong CYP3A4 inducers or inhibitors, which could affect talazoparib plasma concentrations
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Calithera Biosciences, Inc: collaborator
• Pfizer: collaborator
• Prostate Cancer Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

talazoparib

Study Officials

• Richard J Lee, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard J Lee, MD, PhD

CONTACT

(617) 724-4000; rjlee@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: April 1, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)