International, Multicenter, Open-label, Treatment-extension Study for Subjects Who Completed a Phase 1 or Phase 2 Parental Study to Continue Receiving Treatment With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
The duration of the study for an individual participant included:
1. Baseline assessments: within 7 days prior to the first dose of investigational medicinal
product (IMP).
2. Study treatment period(s):
Participants started study treatment at the beginning of the initiation or extension
periods based on the length of prior therapy with SAR245408 or SAR245409
- if <2 cycles, started with initiation period; Participant must have had completed
all the visits in the initiation period before moving to the extension period.
- if >=2 cycles, started with extension period; duration of extension period was
unlimited.
- Participants who took a SAR245408 or SAR245409 daily dose higher than their
established dose of SAR245408 or SAR245409, respectively, in the parental study
entered the study on Day 1 of the initiation period.
- Participants who had dose interrupted in the parental study but fulfilled parental
protocol criteria to restart IMP treatment entered the treatment-extension study on
Day 1 of the initiation period.
- Participants who fulfilled the parental study criteria for IMP treatment
continuation but had ongoing Grade 2 adverse events (AEs) entered the
treatment-extension study on Day 1 of the initiation period.
Participants continued to receive study treatment until disease progression,
unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408
or SAR245409 were available to them outside of the clinical trial.
3. Follow-up assessments: 23 to 37 days after the last dose of IMP.
A Phase I/II Trial of AEZS-108 in Locally Advanced Unresectable or Metastatic Luteinizing Hormone-releasing Hormone(LHRH) Positive Urothelial Carcinoma Patients Who Failed Platinum Based Chemotherapy
AEZS-108 is an investigational drug, combining luteinizing hormone-releasing hormone (LHRH),
an hormone and doxorubicin (a drug approved to treat different types of cancer).
Some tumors, such as those found in the urinary system (also called urothelial carcinomas),
have LHRH hormone receptors to which the LHRH hormone part of AEZS-108 is attracted.
AEZS-108 is expected to work by accumulating mostly on the surface of cancer cells that have
LHRH hormone receptors and by delivering doxorubicin more directly into the cells to kill
them. This would allow the use doxorubicin at lower doses and thus would cause less toxicity.
In the first part of the study, the appropriate dose of AEZS-108 will be determined based on
its side effects. The best dose will be the highest one without severe side effects.
In the second part of the study, this best dose of AEZS-108 will be given to determine its
efficacy to stop the tumor from progressing.
A Randomized, Double-Blind, Placebo-Controlled Study of Chemotherapy Plus Cetuximab in Combination With VTX 2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the
safety and efficacy of VTX 2337 in combination with cisplatin or carboplatin, 5-FU and
cetuximab in prolonging the progression-free survival in subjects with recurrent or
metastatic squamous cell carcinoma of the head and neck.
OBJECTIVES:
Primary Objective:
To compare the efficacy of VTX 2337 plus SOC to SOC alone in prolonging the PFS of patients
with recurrent or metastatic SCCHN using irRECIST evaluated by independent radiology review.
Secondary Objectives:
To compare the following between the two treatment groups:
- Safety of VTX 2337 by adverse events, including clinically significant changes in
physical examination, peripheral blood hematology, serum chemistry, urinalysis, and ECG.
- Efficacy of VTX 2337 plus SOC in prolonging the OS of patients with recurrent or
metastatic SCCHN.
- Efficacy of VTX-2337 plus SOC on ORR, DOBR, DCR, and DDC by irRECIST and evaluation by
independent radiology review.
- Efficacy of VTX-2337 plus SOC on ORR, DOBR, DCR, and DDC by RECIST v1.1 and evaluation
by independent radiology review.
- Efficacy of VTX 2337 plus SOC to SOC alone in prolonging the PFS by RECIST v1.1 and
evaluation by independent radiology review.
- Efficacy of VTX 2337 plus SOC to SOC alone in prolonging the PFS by irRECIST and
evaluation by investigators.
Exploratory Objectives:
- To compare genetic polymorphisms that may impact the response of patients to a TLR8
agonist or to cetuximab between the two treatment groups.
- To compare immune biomarker response to VTX 2337 plus SOC as measured by a multiplexed
panel of cytokines, chemokines, and inflammatory markers between the two treatment
groups.
- To compare the effect of immune cell subsets within the tumor on response to VTX-2337
and/or clinical outcome, as measured by immunohistochemistry in primary tumor tissue
between the two treatment groups.
- To assess the PK of VTX-2337.
OUTLINE:
Subjects will be screened for eligibility (within 14 days) and qualified subjects will be
randomized 1:1 to 1 of 2 treatment groups: SOC + VTX 2337 or SOC + placebo.
Tumor assessments will be by CT or MRI starting at Week 12 (± 3 days), then at Week 18 (± 3
days) and every 8 weeks (± 7 days) thereafter. Response will be evaluated by immune-related
RECIST criteria (irRECIST) and confirmed by an independent radiologist.
Upon independent confirmation of disease progression, active participation in the study is
complete and subjects will undergo the End of Treatment evaluations.
Subjects will be followed for survival until ~12 months after the last subject is randomized.
A Phase 0, Open Label, Non-Randomized, Multi-Center, Exploratory and Safety Study of [F-18]T808
Siemens Molecular Imaging (SMI) is seeking to determine if [F-18]T808 might be useful as a
non-invasive assessment tool in the clinical evaluation of subjects with conditions
associated with tau protein aggregates, such as Alzheimer's disease. The information
collected under this exploratory study will not be used for diagnostic purposes, assessments
of the participant's response to therapy or for clinical management of the participants.
However, this exploratory study will provide baseline information on the safety,
biodistribution, and dosimetry of [F-18]T808. These data will aid in the design of future
studies of [F-18]T808 in patients with Alzheimer's disease. Overall, this study will provide
initial data that inform the development of [F-18]T808 as the first PET imaging agent for
human tau protein related pathology.
A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
Patients were randomized (1:1) to receive buparlisib (100 mg/day) or placebo with fulvestrant
(500 mg); randomization was stratified by PI3K pathway activation status (activated,
non-activated, unknown determined in archival tumor tissue) and visceral disease status
(present or absent). Tumor evaluation was performed 6 weeks after the randomization date and
then every 8 weeks until radiological progression (based on Response Evaluation Criteria In
Solid Tumors [RECIST] version 1.1).
Novartis made the decision not to pursue further development of buparlisib and to terminate
the ongoing studies in the program. Accordingly, on 19-Dec-2016, Novartis notified all the
Investigators about the decision not to pursue further development of buparlisib in Breast
Cancer. As a result, the CBKM120F2302 study was terminated on 19-Apr-2019 (last subject last
visit).
An Open Label Multicentric Phase 1 Study of Oral PI3K/mTOR Inhibitor P7170 in Patients With Advanced Refractory Solid Tumors.
An open label multicentric Phase 1 study of oral PI3K/mTOR inhibitor P7170 in patients with
advanced refractory solid tumors.The study will follow an Accelerated Titration Design (ATD)
with 100% dose increments until significant toxicity as described below; followed by standard
dose titration with 40% dose increments. Dose and schedule (alternate dosing regimen eg. OD,
BID, intermittent) will be determined by the dose escalation outlined in the protocol and
considering pharmacokinetics of the study drug determined from earlier cohorts.
Not recruiting | Any Cancer Condition or Solid Tumor | Multisite
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