What are clinical trials?
Phases of Clinical Trials
Clinical trials of new medicines are done in phases:
• Phase I
• Phase II
• Phase III
Why are clinical trials important?
 They are key to developing new methods to prevent,
detect, and treat cancer.
 To determine whether new treatments are safe,
effective, and work better than current treatments.
 You are adding to our knowledge about cancer and
helping improve cancer care.
How do clinical trials work?
• Protocol
• Consent
• Screening/Eligibility
• Enrollment
How do clinical trials protect participants?
 Scientific Review Board (SRC)
 Institutional Review Board (IRB)
 Office for Human Research Studies (OHRS)
 Data Safety Monitoring Board (DSMB)
Patients’ Rights
 The informed consent document is not a
contract.
 Taking part in a clinical trial is your decision.
 You have the right to withdraw from a
study at any time for any reason.
What to expect
while on a clinical trial
Where are we now in GYN oncology?
• Active trials: ~22
• Trials under review: 6
• Trials close to submission: 1
• New concepts: 7
• Multicenter trials: ~7
Ovarian Cancer
12-159
Phase I Study of the
Oral PI3kinase
Inhibitor BKM120 or
BYL719 and the Oral
PARP Inhibitor
Olaparib in Patients
with Recurrent Triple
Negative Breast
Cancer or High Grade
Serous Ovarian Cancer
• BYL719 is known as a
PI3kinase inhibitor.
• Olaparib is known as a
PARP inhibitor.
Ovarian Cancer
14-263
A Study Evaluating the
Safety and
Pharmacokinetics of
DMUC4064A in
Patients with
Platinum-Resistant
Ovarian Cancer or
Unresectable
Pancreatic Cancer
This is an antibody that has
chemo linked to it. It
delivers the chemo directly
to the cancer cells that have
the DMUC expression.
Ovarian Cancer
14-430
Safety, Tolerability,
and Potential AntiCancer Activity of
Increasing Doses of
AZD5363 in Different
Treatment Schedules
AZD5363 is an AKT
inhibitor that blocks the
pathways for tumor
growth.
Must have a AKT1 or
PIK3CA mutation.
Ovarian Cancer
14-547
A Study of AZD1775 +
Chemotherapy versus
Chemotherapy in
Patients to Treat
Ovarian, Fallopian
Tube, or Peritoneal
Cancer
A randomized phase II
study of AZD1775 plus
chemotherapy versus
chemotherapy alone.
Must have a TP53
mutation.
Ovarian and Endometrial Cancer
12-312
First-In-Human Study
to Evaluate the Safety,
Tolerability,
Pharmacokinetics,
and
Pharmacodynamics of
IMGN853 in Adults
with Ovarian Cancer
and Other FOLR-1
Positive Solid Tumors
IMGN853 is an antibody
that is linked to a
cytotoxic agent that
targets the Folate receptor
(FOLR-1).
Endometrial Cancer
13-520
Study Comparing
AEZS-108/ZoptEC
(Zoptarelin
Doxorubicin in
Endometrial Cancer)
to Doxorubicin as a
Second Line Therapy
for Endometrial
Cancer
AEZS-108 is a molecule
composed of two parts:
• Doxorubicin + a hormone
Cervical Cancer
13-334
GSK1120212 +
GSK2141795 for
Cervical Cancer
• Trametinib is a MEK inhibitor: it
blocks a protein called MEK that
is commonly overactive in tumor
cells.
• GSK2141795 is an AKT inhibitor,
which blocks a pathway (the
PI3kinase pathway) that is
commonly overactive in tumor
cells.
Vulvar Cancer
12-452
Radiation Therapy,
Gemcitabine
Hydrochloride, and
Cisplatin in Treating
Patients with Locally
Advanced Squamous
Cell Carcinoma of the
Vulva.
Radiation therapy together
with gemcitabine and
cisplatin.
Finding Clinical Trials
• www.dana-farber.org/Research/Clinical-Trials.aspx
• www.nih.gov/health/clinicaltrials
• www.clinicaltrials.gov
• www.nhlbi.nih.gov/studies/index.htm