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

NCT02684032

Last updated date
Study Location
UCSF - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
Brief 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 (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Gedatolisib
    Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.
  • Drug: Palbociclib
    Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.
  • Drug: Letrozole
    Letrozole at 2.5 mg daily
  • Drug: Fulvestrant
    Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.
Study Arms  ICMJE
  • Experimental: Letrozole Cohort
    Letrozole combination cohort in dose escalation
    Interventions:
    • Drug: Gedatolisib
    • Drug: Palbociclib
    • Drug: Letrozole
  • Experimental: Fulvestrant cohort
    Fulvestrant combination cohort in dose escalation
    Interventions:
    • Drug: Gedatolisib
    • Drug: Palbociclib
    • Drug: Fulvestrant
  • Experimental: ARM A
    Gedatolisib + palbociclib + letrozole in dose expansion
    Interventions:
    • Drug: Gedatolisib
    • Drug: Palbociclib
    • Drug: Letrozole
  • Experimental: ARM B
    Gedatolisib + palbociclib + fulvestrant in dose expansion
    Interventions:
    • Drug: Gedatolisib
    • Drug: Palbociclib
    • Drug: Fulvestrant
  • Experimental: ARM C
    Gedatolisib + palbociclib + fulvestrant in dose expansion
    Interventions:
    • Drug: Gedatolisib
    • Drug: Palbociclib
    • Drug: Fulvestrant
  • Experimental: Arm D
    Gedatolisib (3:1) + palbociclib + fulvestrant in dose expansion
    Intervention: Drug: Fulvestrant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2018)
148
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2016)
121
Estimated Study Completion Date  ICMJE June 11, 2022
Estimated Primary Completion Date June 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02684032
Other Study ID Numbers  ICMJE B2151009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer 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. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP