Solid TumorsPhase 1/2NCT03965845
A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors
A Phase 1/2 study testing Telaglenestat (CB-839) and Palbociclib Oral Capsule or Tablet [Ibrance] in people with Solid Tumors and NSCLC, run by Calithera Biosciences, Inc at 10 sites in United States.
Trial summary
This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor telaglenestat (CB-839) with the CDK4/6 Inhibitor, palbociclib in participants with advanced/metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, NSCLC, CRC
- What is being tested?
- Telaglenestat (CB-839) and Palbociclib Oral Capsule or Tablet [Ibrance]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 10 sitesUnited States
- Study dates
- 25 Jun 2019to 24 Sep 2021
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1: Have documented incurable/locally advanced or metastatic solid tumors that have either relapsed or are refractory or intolerant to the standard therapies of proven clinical benefit.
- Part 2: Availability of archival tumor tissue block or slides (Fresh tumor biopsy will be required if archival tissue is not available)
- Part 2, Cohort 1: Incurable/locally advanced or metastatic KRAS-mutant CRC previously treated with systemic therapy (examples include: oxaliplatin-, irinotecan-and 5 FU-based chemotherapy (unless contraindicated) with or without bevacizumab)
- Part 2, Cohort 2: Incurable/locally advanced or metastatic KRAS-mutant NSCLC previously treated with systemic chemotherapy including platinum-based and anti-PD-1/PDL-1 therapy (unless contraindicated)
- Part 2, Cohort 3: Advance KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC) harboring a mutation or loss in CDKN2A (PDAC) and received treatment with one or more lines of systemic chemotherapy with FOLFIRINOX and/or gemcitabine/abraxane in the neoadjuvant, adjuvant, or metastatic disease setting or unable to receive standard of care chemotherapy
- Cohort 4 may be opened only if Cohort 3 achieves predefined criteria for efficacy
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- -Part 2 Cohort 4: Advanced KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC). · Histological or cytological diagnosis of advanced or metastatic KRAS-mutant with CDKN2A wild type (PDAC) and received treatment with one or more lines of systemic chemotherapy with FOLFIRINOX and/or gemcitabine/abraxane in the neoadjuvant, adjuvant, or metastatic disease setting or unable to receive standard of care chemotherapy.
- For both Part 1 and 2:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Ability to provide written consent in accordance with federal, local and institutional guidelines
- PER RECIST v1.1 evaluable disease (for part 1) or measurable disease (for Part 2)
- Recovery to baseline or to Grade 1 CTCAE v5.0 of toxicities that were related to prior therapies
Who cannot join
- Prior treatment with CB-839 or palbociclib
- Unable to receive oral medication
- Infection requiring more than 5 days of parenteral antibiotics, antivirals, or antifungals within two weeks prior to C1D1
- Unable to discontinue proton pump inhibitor use before study treatment
- Refractory nausea and vomiting, uncontrolled diarrhea, malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes or other situation that may preclude adequate absorption
- Active and/or untreated central nervous system metastasis. Patients with treated brain metastasis must have (1) documented radiographic stability of at least 4 weeks in duration demonstrating on baseline central nervous system imaging prior to study treatment and (2) be symptomatically stable and off steroids for at least 2 weeks before administration of any study treatment.
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- Major surgery within 28 days prior to first dose of study drug
- Receipt of any anticancer therapy within the following windows:
- small molecule TKI therapy (including investigational) within 2 weeks or 5 half-lives prior to expected Cycle 1 Day 1 dose
- any type of anti-cancer antibody or cytotoxic chemo within 4 weeks prior to Cycle 1 Day 1 Dose
- radiation therapy for bone metastasis within 2 weeks prior or any other external radiation therapy within 4 weeks prior to C1D1
- patients with clinically relevant ongoing complications from prior radiation therapy are not eligible
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory, Winship Cancer Institute
Atlanta, Georgia, 30322
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
MD Anderson
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
Sarah Cannon Research Institute- Tennessee Oncology
Nashville, Tennessee, 37203
Regions Cancer care Center
Saint Paul, Minnesota, 55101
South Texas Accelerated Research Therapeutic, LLC
San Antonio, Texas, 78229
UCLA Hematology/Oncology
Santa Monica, California, 90095
About this study
Official title: A Phase 1b/2, Open Label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination With CDK4/6 Inhibitor Palbociclib in Patients With Advanced or Metastatic Solid Tumors
This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor telaglenestat (CB-839) with the CDK4/6 Inhibitor, palbociclib in participants with advanced/metastatic solid tumors.
- Conditions
- Solid Tumors, NSCLC, CRC, KRAS Gene Mutation
- Being tested
- Telaglenestat (CB-839), Palbociclib Oral Capsule or Tablet [Ibrance]
- Keywords
- Tumor Metabolism, Glutaminase Inhibitor, CB-839, Palbociclib, PALBO, Telaglenestat, CDK4/6, CDK4, CDK6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telaglenestat (CB-839)Drug
Teleglenastat is an oral tablet administered twice daily with food at the assigned dose level. Dose is taken with palbociclib each day in 28-day cycles.
Palbociclib Oral Capsule or Tablet [Ibrance]Drug
Also called Ibrance
Palbociclib (Ibrance) is an oral capsule or tablet administered once daily with food on Days 1-21 of every 28-day cycle in combination with telaglenestat. Days 22-28 of every cycle, palbociclib is not taken.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Telaglenastat 600 mg and Palbociclib 75 mg | Experimental | Not described Receives: Drug: Telaglenestat (CB-839); Drug: Palbociclib Oral Capsule or Tablet [Ibrance] |
| Cohort 2: Telaglenastat 800 mg and Palbociclib 75 mg | Experimental | Not described Receives: Drug: Telaglenestat (CB-839); Drug: Palbociclib Oral Capsule or Tablet [Ibrance] |
| Cohort 3: Telaglenastat 800 mg and Palbociclib 100 mg | Experimental | Not described Receives: Drug: Telaglenestat (CB-839); Drug: Palbociclib Oral Capsule or Tablet [Ibrance] |
| Cohort 3: Telaglenastat 800 mg and Palbociclib 125 mg | Experimental | Not described Receives: Drug: Telaglenestat (CB-839); Drug: Palbociclib Oral Capsule or Tablet [Ibrance] |
| Part 2: Expansion | Experimental | The recommended phase 2 dose (RP2D) determined from Part 1 will be the treatment for all cohorts in expansion Part 2. Receives: Drug: Telaglenestat (CB-839); Drug: Palbociclib Oral Capsule or Tablet [Ibrance] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of telaglenestat (CB-839) in combination with palbociclib: (CR) number of participants with treatment related adverse events
Number of participants with treatment related adverse events as assessed by CTCAE v5.0
Measured: Start of treatment to 28 days post treatment
Maximum tolerated dose and/or Recommended Phase 2 Dose:
Incidence and nature of dose-limiting toxicities
Measured: Measured from Part 1 patients only within their first 28 day cycle
Secondary outcomes (2)
Maximum plasma concentration of telaglenastat and palbociclib:
Non-compartmental method of analysis will be used to analyze the plasma concentrations
Measured: PKs are drawn on two different days (Day 8 and Day 15) during Cycle 1
Anti-tumor activity of telaglenestat and palbociclib:
Change in tumor size from baseline
Measured: Approximately every 8 weeks until disease progression, for approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start25 Jun 2019
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calithera Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emil Kuriakose, MD, Study director, Calithera Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965845
- Sponsor's protocol ID
- CX-839-012
- Status last verified
- Sep 2022
- First submitted
- 24 May 2019
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Open Label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination With CDK4/6 Inhibitor Palbociclib in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03965845
- Acronym / sponsor ID
- CX-839-012
- Conditions
- Solid Tumors, NSCLC, CRC, KRAS Gene Mutation
- Keywords
- Tumor Metabolism, Glutaminase Inhibitor, CB-839, Palbociclib, PALBO, Telaglenestat, CDK4/6, CDK4
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Calithera Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor telaglenestat (CB-839) with the CDK4/6 Inhibitor, palbociclib in participants with advanced/metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Telaglenastat 600 mg and Palbociclib 75 mg | Experimental | Drug: Telaglenestat (CB-839), Drug: Palbociclib Oral Capsule or Tablet [Ibrance] |
| Cohort 2: Telaglenastat 800 mg and Palbociclib 75 mg | Experimental | Drug: Telaglenestat (CB-839), Drug: Palbociclib Oral Capsule or Tablet [Ibrance] |
| Cohort 3: Telaglenastat 800 mg and Palbociclib 100 mg | Experimental | Drug: Telaglenestat (CB-839), Drug: Palbociclib Oral Capsule or Tablet [Ibrance] |
| Cohort 3: Telaglenastat 800 mg and Palbociclib 125 mg | Experimental | Drug: Telaglenestat (CB-839), Drug: Palbociclib Oral Capsule or Tablet [Ibrance] |
| Part 2: Expansion | Experimental | Drug: Telaglenestat (CB-839), Drug: Palbociclib Oral Capsule or Tablet [Ibrance]The recommended phase 2 dose (RP2D) determined from Part 1 will be the treatment for all cohorts in expansion Part 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Part 1: Have documented incurable/locally advanced or metastatic solid tumors that have either relapsed or are refractory or intolerant to the standard therapies of proven clinical benefit.
- Part 2: Availability of archival tumor tissue block or slides (Fresh tumor biopsy will be required if archival tissue is not available)
- Part 2, Cohort 1: Incurable/locally advanced or metastatic KRAS-mutant CRC previously treated with systemic therapy (examples include: oxaliplatin-, irinotecan-and 5 FU-based chemotherapy (unless contraindicated) with or without bevacizumab)
- Part 2, Cohort 2: Incurable/locally advanced or metastatic KRAS-mutant NSCLC previously treated with systemic chemotherapy including platinum-based and anti-PD-1/PDL-1 therapy (unless contraindicated)
- Part 2, Cohort 3: Advance KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC) harboring a mutation or loss in CDKN2A (PDAC) and received treatment with one or more lines of systemic chemotherapy with FOLFIRINOX and/or gemcitabine/abraxane in the neoadjuvant, adjuvant, or metastatic disease setting or unable to receive standard of care chemotherapy
Key exclusion criteria (12 listed)
- Prior treatment with CB-839 or palbociclib
- Unable to receive oral medication
- Infection requiring more than 5 days of parenteral antibiotics, antivirals, or antifungals within two weeks prior to C1D1
- Unable to discontinue proton pump inhibitor use before study treatment
- Refractory nausea and vomiting, uncontrolled diarrhea, malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes or other situation that may preclude adequate absorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telaglenestat (CB-839)Teleglenastat is an oral tablet administered twice daily with food at the assigned dose level. Dose is taken with palbociclib each day in 28-day cycles. | Drug | Cohort 1: Telaglenastat 600 mg and Palbociclib 75 mg, Cohort 2: Telaglenastat 800 mg and Palbociclib 75 mg, Cohort 3: Telaglenastat 800 mg and Palbociclib 100 mg, Cohort 3: Telaglenastat 800 mg and Palbociclib 125 mg, Part 2: Expansion |
| Palbociclib Oral Capsule or Tablet [Ibrance]Also: IbrancePalbociclib (Ibrance) is an oral capsule or tablet administered once daily with food on Days 1-21 of every 28-day cycle in combination with telaglenestat. Days 22-28 of every cycle, palbociclib is not taken. | Drug | Cohort 1: Telaglenastat 600 mg and Palbociclib 75 mg, Cohort 2: Telaglenastat 800 mg and Palbociclib 75 mg, Cohort 3: Telaglenastat 800 mg and Palbociclib 100 mg, Cohort 3: Telaglenastat 800 mg and Palbociclib 125 mg, Part 2: Expansion |
Primary outcome
Safety and Tolerability of telaglenestat (CB-839) in combination with palbociclib: (CR) number of participants with treatment related adverse events
Time frame: Start of treatment to 28 days post treatment
Number of participants with treatment related adverse events as assessed by CTCAE v5.0
Maximum tolerated dose and/or Recommended Phase 2 Dose:
Time frame: Measured from Part 1 patients only within their first 28 day cycle
Incidence and nature of dose-limiting toxicities
2 secondary outcomes
Maximum plasma concentration of telaglenastat and palbociclib:
Time frame: PKs are drawn on two different days (Day 8 and Day 15) during Cycle 1
Anti-tumor activity of telaglenestat and palbociclib:
Time frame: Approximately every 8 weeks until disease progression, for approximately 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emil Kuriakose, MD study director
Calithera Biosciences, Inc
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Telaglenestat (CB-839) and Palbociclib Oral Capsule or Tablet [Ibrance] in people with Solid Tumors and NSCLC, run by Calithera Biosciences, Inc at 10 sites 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 12 inclusion and 12 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: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and Tolerability of telaglenestat (CB-839) in combination with palbociclib: (CR) number of participants with treatment related adverse events (time frame: Start of treatment to 28 days post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2022.