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Prostate Cancer MetastaticPhase 2NCT04824937

Telaglenastat + Talazoparib In Prostate Cancer

A Phase 2 study testing Telaglenastat and Talazoparib in people with Prostate Cancer Metastatic, run by Massachusetts General Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
Telaglenastat and Talazoparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2021to 31 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • Agree to use a male condom and have their partner use a contraceptive method with a failure rate of <1% per year (intrauterine device or hormonal implant).
  • Patients/participants must refrain from donating sperm for the duration of the study.
  • Patients/participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration for the duration of the study.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: A Phase II Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination With the PARP Inhibitor Talazoparib in Participants With Metastatic Castration-Resistant Prostate Cancer

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
Read the detailed description

This research study is a Phase II clinical trial, researching the effectiveness of the combination of telaglenastat and talazoparib in participants with metastatic castration-resistant prostate cancer (mCRPC).

The U.S. Food and Drug Administration (FDA) has not approved telaglenastat or the combination of telaglenastat and talazoparib as a treatment for any disease.

The FDA has not approved talazoparib for metastatic castration-resistant prostate cancer (mCRPC) but it has been approved for other uses.

Telaglenastat is a drug designed to stop cancer growth by blocking glutaminase activity. Glutaminase is an enzyme in the body that is overproduced by some cancers and can fuel cancer growth. Telaglenastat can lower or block glutaminase and may slow the growth or spread of some cancers.

Talazoparib is a drug that interferes with the repair activity of proteins called poly adenosine diphosphate ribose polymerases (PARP), which are found in normal and cancer cells and are involved in the repair of DNA - the genetic material found in every cell. This interference may lead to increased amounts of DNA defects and cancer cell death which may help to slow the growth of cancer cells.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

There are different points in this study in which participation will start. The first group of participants will receive the combination of telaglenastat and talazoparib for the entirety of the study. If telaglenastat plus talazoparib is beneficial to the first group this will lead to the enrollment of the next group, since telaglenastat as a single drug has not been evaluated in prostate cancer. The next group will receive telaglenastat alone with the addition of talazoparib if the disease gets worse.

It is expected that about 30 people will take part in this research study.

Being tested
Telaglenastat, Talazoparib
Keywords
Prostate Cancer Metastatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelaglenastatDrug

    Also called CB 839

    Capsule, taken by mouth

  • TalazoparibDrug

    Also called Taken orally

    Capsule, taken by mouth

Study groups in NCT04824937
Study groupRoleWhat they receive
Telaglenastat + TalazoparibExperimentalDuring 28 day study cycles, participants will receive: * Telaglenastat 2x daily at a predetermined dose * Talazoparib 1x daily at a predetermined dose
Receives: Drug: Telaglenastat; Drug: Talazoparib
Telaglenastat + Talazoparib StaggeredExperimentalIf 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.
Receives: Drug: Telaglenastat; Drug: Talazoparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of objective responses

    Assessed by RECIST1.1

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

  2. Rate of participants with clinical benefit

    Assessed by RECIST1.1

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

  3. Rate of complete responses

    Assessed by RECIST1.1

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

  4. Rate of partial responses

    Assessed by RECIST1.1

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

  5. Rate of participants with progressive disease

    Assessed by RECIST1.1

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

  6. Rate of participants with stable disease

    Assessed by RECIST1.1

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

Secondary outcomes (1)

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

    The number and proportion of adverse events, graded as defined by CTCAE version 5.0 will be tabulated by type and grade. This analysis will be performed overall and separately for Cohort 1 and 2. Within a given patient, a given adverse event will be counted only once at the highest grade.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study startJul 2021 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Why it stopped: Calithera pulled out of this trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04824937
Sponsor's protocol ID
20-325
Status last verified
Oct 2026
First submitted
8 Feb 2021
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telaglenastat and Talazoparib in people with Prostate Cancer Metastatic, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of objective responses (time frame: Measured from the start of the treatment through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04824937.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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