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

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02684032

Run by

Celcuity Inc

People needed

141

Starts

2016-06-14

Expected to finish

2022-01-19

Last updated by the study team

2022-07-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc. — Corona, California, United States
• Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc. — Fountain Valley, California, United States
• Keck Hospital of USC - Norris Healthcare Center (HC3) — Los Angeles, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• LAC+USC Medical Center — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center / Investigational Drug Services — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc. — Riverside, California, United States
• UCSF - Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• UCSF - Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• University of Colorado Hospital - Anschutz Inpatient Pavilion (AiP) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) — Aurora, Colorado, United States
• University of Colorado Hospital - Clinical Trials Office (CTO) — Aurora, Colorado, United States
• University of Colorado Hospital- Anschutz Cancer Pavilion (ACP) — Aurora, Colorado, United States
• Moffitt Cancer Center Richard M Schulze Family Foundation Outpatient Center at McKinley Campus — Tampa, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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