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Breast CancerPhase 1NCT02684032

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

A Phase 1 study testing Gedatolisib, Palbociclib and Letrozole in people with Breast Cancer, run by Celcuity Inc at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Gedatolisib, Palbociclib and Letrozole
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
41 sitesUnited States
Study dates
14 Jun 2016to 19 Jan 2022
Phase
Phase 1
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women 18 years of age or older, who are either: Postmenopausal or Pre/perimenopausal women with medically-induced menopause by treatment with agents to induce chemical menopause.
  • Histologically or cytologically proven diagnosis of breast cancer with evidence of metastasis.
  • Documentation of estrogen receptor positive ((ER+), human epidermal growth factor receptor 2 (HER2 negative (HER2-)) tumor.
  • Dose Escalation Portion: Patients must satisfy one of the following criteria:
  • Letrozole combination cohort (L): metastatic breast cancer (MBC) with progression who are candidates for a letrozole-containing regimen, with palbociclib.
  • Fulvestrant combination cohort (F): MBC with progression who are candidates for a fulvestrant containing regimen, with palbociclib.
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  • Dose Expansion Portion: Patients must satisfy one of the following criteria:
  • Arm A: MBC with progression and no prior endocrine based systemic therapy in the metastatic setting;
  • Arm B: MBC with progression during or following one prior endocrine based systemic therapy in the metastatic setting, with no prior therapy with any cyclin-dependent kinase (CDK) inhibitor;
  • Arm C/Arm D: MBC with progression during or following one or two prior endocrine based systemic therapies in the metastatic setting, and following prior therapy with a CDK inhibitor.
  • Measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
  • Bone only patients during dose escalation portion.
  • Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available.
  • Eastern Cooperative Oncology Group [ECOG] performance must be 0 or 1.
  • Adequate bone marrow, renal and liver function.

Who cannot join

  • Prior treatment with a mechanistic target of rapamycin (mTOR) inhibitor or phosphoinositide 3-kinase (PI3K) inhibitor.
  • More than 1 line of prior chemotherapy in the treatment of metastatic or locally advanced/recurrent disease.
  • Bone only patients during expansion/efficacy portion.
  • Patients with advanced/metastatic disease who have symptomatic visceral spread, and who have life threatening complications needing immediate therapy, such as massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver replacement with tumor.
  • Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases.
  • Active bacterial, fungal or viral infection.
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  • Uncontrolled or significant cardiovascular disease.
  • Radiation therapy within 4 weeks of investigational product.
  • Cytotoxic chemotherapy within 4 weeks of investigational product (6 weeks for mitomycin C or nitrosoureas) if immediate prior regimen was administered on an every 3 4 week schedule or 2 weeks of investigational product if immediate prior regimen consisted of weekly therapy.
  • Any other anti cancer agents (eg, hormonal, biological, investigational) within 5 times the half life prior to investigational product.
  • Impairment of gastro intestinal (GI) function or GI disease.
  • Pregnant female patients; breastfeeding female patients; and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for 90 days.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AiP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Clinical Trials Office (CTO)

    Aurora, Colorado, 80045

  • University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • UNC Cancer Hospital Infusion Pharmacy

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • The Ohio State University Wexner Medical Center James Cancer Hospital

    Columbus, Ohio, 43210

  • Stefanie Spielman Comprehensive Breast Cancer

    Columbus, Ohio, 43212

  • Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.

    Corona, California, 92879

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Karmanos Cancer Institute

    Farmington Hills, Michigan, 48334

  • Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.

    Fountain Valley, California, 92708

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • U.T. MD Anderson Cancer Center

    Houston, Texas, 77030

  • Keck Hospital of USC - Norris Healthcare Center (HC3)

    Los Angeles, California, 90033

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • LAC+USC Medical Center

    Los Angeles, California, 90033

  • USC/Norris Comprehensive Cancer Center / Investigational Drug Services

    Los Angeles, California, 90033

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

  • Thomas Jefferson University - Clinical and Regulatory

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.

    Riverside, California, 92501

  • UCSF - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • UCSF - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

  • Seattle Cancer Care Alliance (SCCA) Investigational Drug Services

    Seattle, Washington, 98109

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Moffitt Cancer Center Richard M Schulze Family Foundation Outpatient Center at McKinley Campus

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: PHASE 1B STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND CLINICAL ACTIVITY OF GEDATOLISIB IN COMBINATION WITH PALBOCICLIB AND EITHER LETROZOLE OR FULVESTRANT IN WOMEN WITH METASTATIC OR LOCALLY ADVANCED/RECURRENT BREAST CANCER (MBC)

This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.

Read the detailed description

This is a multicenter, open label, continuous Phase 1b study in patients with MBC. This study will have a dose escalation and expansion. The dose escalation will identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole. The expansion will estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole and the combination of gedatolisib plus palbociclib/fulvestrant.

Conditions
Breast Cancer
Being tested
Gedatolisib, Palbociclib, Letrozole, Fulvestrant
Keywords
PI3K (phosphoinositide 3-kinase), mTOR (mechanistic target of rapamycin), PI3K/mTOR, metastatic breast cancer (MBC), ER+ (estrogen receptor positive), HER2- (human epidermal growth factor receptor 2 negative)
Medical subject headings
Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies

What participants receive

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

  • GedatolisibDrug

    Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.

  • PalbociclibDrug

    Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.

  • LetrozoleDrug

    Letrozole at 2.5 mg daily

  • FulvestrantDrug

    Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.

Study groups in NCT02684032
Study groupRoleWhat they receive
Letrozole CohortExperimentalLetrozole combination cohort in dose escalation
Receives: Drug: Gedatolisib; Drug: Palbociclib; Drug: Letrozole
Fulvestrant cohortExperimentalFulvestrant combination cohort in dose escalation
Receives: Drug: Gedatolisib; Drug: Palbociclib; Drug: Fulvestrant
ARM AExperimentalGedatolisib + palbociclib + letrozole in dose expansion
Receives: Drug: Gedatolisib; Drug: Palbociclib; Drug: Letrozole
ARM BExperimentalGedatolisib + palbociclib + fulvestrant in dose expansion
Receives: Drug: Gedatolisib; Drug: Palbociclib; Drug: Fulvestrant
ARM CExperimentalGedatolisib + palbociclib + fulvestrant in dose expansion
Receives: Drug: Gedatolisib; Drug: Palbociclib; Drug: Fulvestrant
Arm DExperimentalGedatolisib (3:1) + palbociclib + fulvestrant in dose expansion
Receives: Drug: Fulvestrant

What is being measured

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

  1. Number of participants with dose limiting toxicities

    Measured: up to 28 days

  2. Objective response rate observed in patients in the dose expansion portion

    Number of patients for each response category, objective response rate (number of patients with a complete response (CR)) relative to the number of response evaluable patients

    Measured: 16 weeks

  3. Objective response rate observed in patients in the dose expansion portion

    Number of patients for each response category, objective response rate (number of patients with a partial response (PR)) relative to the number of response evaluable patients)

    Measured: 16 weeks

Secondary outcomes (5)

  1. Tumor response observed in patients in the dose escalation portion

    Measured: 16 weeks

  2. Duration of response

    Measured: 16 weeks

  3. QTc interval (corrected QT interval)

    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle.

    Measured: Screening up to 6 months

  4. Maximum observed plasma concentration

    Measured: Day 1: 0, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 24, 72 and 168 hours. Cycle 2 Day 1: 0, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 24, 72 and 168 hours

  5. Progression free survival

    Measured: 16 weeks

Timeline

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

  1. First posted17 Feb 2016 (estimated)
  2. Study start14 Jun 2016
  3. Primary completion19 Jan 2022
  4. Study completion19 Jan 2022

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02684032
Sponsor's protocol ID
B2151009
Status last verified
Jul 2022
First submitted
10 Feb 2016
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Celcuity will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

Publications

  • Layman RM, Han HS, Rugo HS, Stringer-Reasor EM, Specht JM, Dees EC, Kabos P, Suzuki S, Mutka SC, Sullivan BF, Gorbatchevsky I, Wesolowski R. Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study. Lancet Oncol. 2024 Apr;25(4):474-487. doi: 10.1016/S1470-2045(24)00034-2.

    PubMed 38547892

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gedatolisib, Palbociclib and Letrozole in people with Breast Cancer, run by Celcuity Inc at 41 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 15 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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 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.

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?

Number of participants with dose limiting toxicities (time frame: up to 28 days). The study lists 3 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 NCT02684032, which also lists 1 linked publication.

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 27 Jul 2022.

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