A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma
This is an open label, multi-center, single arm phase II study. The study will investigate
the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of
patients with recurrent or persistent PrR-negative endometrial cancer.
Eligible patients will be enrolled into the study and administered sodium cridanimod in
combination progestin therapy. Objective responses will be assessed at 12 week intervals.
Patients will be treated for a 12 month period, followed by an additional 12 month follow up
period or to disease progression whichever occurs first.
Important objectives of the study are to investigate the effect of sodium cridanimod in
conjunction with progestin therapy on the level of PrR in tumor tissue and how this
correlates to efficacy. To accomplish this objective, some of the patients enrolled in the
study will undergo two tumor biopsies that will allow measurement of PrR levels in the tumor
tissue before the treatment and after 4 weeks of therapy.
A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This is a randomized (individuals assigned to study treatment by chance), open-label
(identity of assigned study drug will be known), active-controlled study in adult female
patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal,
or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.
Approximately 670 participants will be enrolled. Patients will be stratified by 4 criteria
defined in the protocol and randomly assigned in a 1:1 ratio to the trabectedin+DOXIL
combination therapy group (Arm A) or to the DOXIL (pegylated liposomal doxorubicin)
monotherapy group (Arm B). During the treatment phase, patients will receive study drug
infusions according to 21-day cycles in Arm A and 28-day cycles in Arm B. Treatment will
continue until the occurrence of disease progression or unacceptable treatment toxicity, or
until 2 cycles beyond a confirmed complete response is documented. Up to 2 additional cycles
of study drug are allowed after complete response, at the discretion of the principal
investigator. Efficacy assessments will be evaluated using Response Evaluation Criteria in
Solid Tumors. Disease assessments, including assessments for patients who discontinue
treatment for reasons other than disease progression, will be performed until disease
progression, the start of subsequent anticancer therapy, withdrawal of consent, or the
clinical cutoff date. Collection of survival status will continue until at least 514 deaths
have been observed. Serial pharmacokinetic (PK) samples will be collected in a subset of
patients who voluntarily consent to the PK portion of the study. Safety will be monitored
throughout the study. An interim analysis of overall survival (OS) will be performed after
approximately 308 participants have died. The final analysis of OS will occur when
approximately 514 deaths have been observed.
Phase 1 Study of Anti-HB-EGF Monoclonal Antibody KHK2866 as Monotherapy in Subjects With Advanced Solid Tumors and in Combination With Chemotherapy in Ovarian Cancer
During Phase 1a, groups of eligible patients with advanced solid tumors will receive KHK2866
as monotherapy in escalating doses. The Phase 1b portion will enroll patients with ovarian
cancer who will receive KHK2866 in combination with one of three chemotherapy regimens
(Arms): gemcitabine+carboplatin (platinum-sensitive, weekly paclitaxel (platinum-resistant),
or pegylated liposomal doxorubicin (platinum-resistant). Escalating doses of the combination
of KHK2866 and the chemotherapy regimen will given to two groups of subjects per Arm. The
goal of the study is to learn about the side effects of KHK2866 alone or given in combination
with chemotherapy. All subjects will receive study therapy for up to 6 cycles (up to 12
cycles for subjects assigned to PLD [Arm 3 of Phase 1b]), or until disease progression, the
development of severe side effects, noncompliance or withdrawal of consent by the subject, or
other removal criteria whichever comes first.