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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

Last updated on April 6, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
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: 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.

NCT02684032
Pfizer
Recruiting
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

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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
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.
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.
Interventional
Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
November 24, 2019
November 24, 2019   (Final data collection date for primary outcome measure)

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: 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.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]r.com
United States
 
 
NCT02684032
B2151009
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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