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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:June 14, 2016
End Date:June 16, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

Use our guide to learn which trials are right for you!

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.

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.
We found this trial at
46
sites
8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Ann Arbor, Michigan 48106
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
12605 East 16th Avenue
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
13001 East 17th Place
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
1665 Aurora Court
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Chapel Hill, North Carolina 27514
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Corona, CA
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
4100 John R Street
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
719 Thompson Lane
Nashville, Tennessee 37204
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
130 South 9th Street
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Riverside, CA
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials