Symptoms and General Pathology

All Conditions

Hypoxia

Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IA, patients will not have any cancer therapy prior to removal of the OxyChip and duration of implantation is typically less than 4 weeks but may be up to 52 weeks.

Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IB, patients will have standard of care neoadjuvant chemotherapy or pre-operative radiation therapy during the time that the OxyChip is within the tumor, which is typically 6 weeks but may be up to 52 weeks.

The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).

OxyChip

Philip E Schaner, M.D., Ph.D.

Periannan Kuppusamy, Ph.D.

Tumors with low oxygen levels are associated with poor prognosis and resistance to standard radiotherapy or systemic therapies. The ability to make repeated oxygen measurements in tumors could be used to help select the most effective treatment or the best timing to start therapies. The purpose of this study is to ascertain the safety and feasibility of using an implantable oxygen sensor, known as the OxyChip, to make oxygen measurements in tumors using EPR oximetry, a technique related to magnetic resonance imaging (MRI).

This is an early feasibility Phase I clinical trial for safety. The total enrollment for this study is 60 patients (30 per phase). The study is split in a phase IA (short duration of implantation with no other cancer therapy planned prior to excision) and a phase IB (duration of implantation for up to 52 weeks while receiving neoadjuvant radiation therapy or systemic therapy prior to surgical excision), as described below.

The initial 6 patients will have the OxyChip placed for a short duration (up to 4 weeks) after which the OxyChip will be removed when the tumor mass is resected, prior to delivery of any further therapies. After the successful implantation, removal, and evaluation of the OxyChip in the first 6 Phase IA patients, enrollment will be opened to an additional 24 Phase IA patients and to 6 Phase IB patients who will either receive neoadjuvant radiotherapy or systemic therapy (chemotherapy, biologic therapy, or endocrine therapy) while the OxyChip is in place. After the successful implantation, removal, and evaluation of the OxyChip in the first 3 Phase IB patients receiving radiation therapy or systemic therapy, enrollment will be opened to an additional 24 Phase IB patients. Up to five oxygen measurements per week will be made during the course of radiation or systemic therapy. The OxyChips will be removed at surgery. Patients receiving radiation or systemic therapy will be evaluated at least weekly for assessment with respect to any adverse events for the primary objective and oximetry measurements will be taken periodically at least one day after implantation and up to its removal at the planned tumor excision to assess the secondary objective. Following resection, the tissue surrounding the OxyChip will be examined for any adverse events for the primary objective. For the exploratory objectives, the tissue will also be examined for biomarkers associated with hypoxia or growth.

There are two parallel arms of the study; however, the first 6 patients must be in the arm whose tumor will receive no therapy prior to surgical resection. If there are no safety issues, then both arms are open.

Oxygen Measurements in Subcutaneous Tumors by EPR Oximetry Using OxyChip

A Single-Institutional, Phase 1 Trial of Repeated Oxygen Measurements in Subcutaneous Tumors by Electron Paramagnetic Resonance (EPR) Oximetry Using an Implantable Oxygen Sensor (OxyChip)

This is a safety study to demonstrate that the OxyChip will be well-tolerated with minimal risk for complications. All tumors will be excised with the OxyChip in place, and histology will be analyzed for signs of tissue reaction and inflammation adjacent to the OxyChip. pathologic findings associated with the OxyChip are reported.

This is a safety study to demonstrate that the implantation procedure, the OxyChip and any subsequent oxygen measurements will be well-tolerated with minimal risk for complications.

This study will also determine the feasibility of repeated measurements of pO2 in tumors using the OxyChip and EPR oximetry. Tumor pO2 values will be reported in millimeters of mercury (mmHg).

Two types of measurements (Data) were made: (i) Baseline tumor pO2 values in patients breathing room air during the first up to 10 min period; and (ii) Hyperoxygenation pO2 values at the end of patients breathing 100% oxygen gas for up to 10 min. The hyperoxygenation was administered immediately following the baseline (room-air breathing) measurements.

This study will also determine the feasibility of repeated measurements of oxygen in tumors using the OxyChip and EPR oximetry. We will determine the workflow and time required for each daily oxygen measurement. The measurement time, averaged over multiple measurements on each patient, will be reported as less than or greater than one hour.

National Cancer Institute (NCI)

Periannan Kuppusamy

Scientific Director

Events were evaluated for associated toxicity using the Common Terminology Criteria for Adverse Events (CTCAE);

Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IA, patients will not have any cancer therapy prior to removal of the OxyChip and duration of implantation is typically less than 4 weeks but may be up to 52 weeks.

OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).

IA No Treatment Except Standard-of-care (SOC) Surgery

Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IB, patients will have standard of care neoadjuvant chemotherapy or pre-operative radiation therapy during the time that the OxyChip is within the tumor, which is typically 6 weeks but may be up to 52 weeks.

OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).

IB SOC Adjuvant Therapy and SOC Surgery

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Periannan (Kupps) Kuppusamy MS, PhD

Focal disrupted tissue at edge of tumor with mild nonspecific chronic inflammation

Focal fibrosis, macrophages, and apparent tumor cavitation

Focal organizing fat necrosis

Mild macrophage and foreign body type giant cell reaction at OxyChip site

Mild macrophage predominant chronic inflammatory reaction at needle site

Minimal fat necrosis, macrophage infiltrate immediately surrounding the OxyChip

Minor focal hemorrhage seen adjacent to the deep margin. Very focal collection of macrophages.

Minor hemorrhage at site of injection

Tumor necrosis and mild hemorrhage immediately adjacent to injection site

Tumor necrosis near chip site.

No histologic response seen

Focal fibrosis, a few macrophages adjacent

The OxyChip could not be found for two participants. The chip was presumed to be lost at the time of surgery for one participant and presumed lost prior to surgery due to rapidly progressive tumor necrosis.

Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation

Discomfort at surgical site

Mild discomfort and bleeding from implantation procedure. Bruising from implantation needle

Mild discomfort from implantation

Minimal bleeding associated with implantation. Mild bruising at needle insertion site

Minor bleeding asociated w implantation. Minor bruising needle ins site. Mild discomfort of L breast

Minor bleeding from implantation needle

Minor bleeding from implantation needle. Mild bruising.

Minor bruising associated with implantation site

No Adverse Events Recorded

Pain and minor bleeding from implantation needle

Pruritis

Pruritis, scalp

Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)

Baseline pO2 data

Hyperoxygen pO2 data measured immediately following baseline pO2 data

For Arm 1A, 4 subjects were not measured. For Arm 1B, 4 subjects were not measured.

Measurement of Tumor Partial Pressure of Oxygen (pO2) Levels Using the OxyChip Sensor and EPR Oximetry

One subject from IA had Oxychip presumed lost at time of surgery. 4 subjects from each group were not able to be measured.

The Time Required to Complete EPR Oximetry Measurements

Overall Study

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

The combination of ombrabulin and bevacizumab will be administered every 3 weeks according to the following schedule: One day 1, ombrabulin will be administered as a 30 minutes intravenous (i.v) infusion. Bevacizumab will be administered as a 30-90 minutes i.v. infusion 24 hours after the end of ombrabulin infusion on day 2.

Pharmaceutical form:Solution for infusion

Route of administration: Intravenous

Ombrabulin (AVE8062)

bevacizumab

Clinical Sciences & Operations

Primary Objective:

- To determine the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of ombrabulin in combination with best tolerated dose of bevacizumab based on the incidence of related Dose Limiting Toxicities (DLTs).

Secondary Objectives:

* To assess the overall safety profile of the combination
* To characterize the pharmacokinetic (PK) profile of both ombrabulin and bevacizumab when given in combination
* To evaluate preliminary evidence of anti-tumor activity
* To assess the pharmacodynamic effect using (Dynamic Contrast Enhanced Ultra-Sound) DCE-US, measuring biomarkers

The duration of the study for each patient will include an up to 28-day screening phase, 21-day study treatment cycles, an end of treatment visit with a follow-up period. Each patient will participate in only one dose group and will receive AVE8062 with bevacizumab every 3 weeks until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision.

Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors

An Open-label, Non-randomized, Dose Escalation, Safety and Pharmacokinetic Phase I Study of Ombrabulin (AVE8062) in Combination With Bevacizumab Administered by Intravenous Infusion Every 3 Weeks in Patients With Advanced Solid Tumors.

Sanofi

Radiofrequency tumor ablation (RFA) is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.

Radiofrequency ablation (RFA)

Fredric A Hoffer, MD

This is a single-center, Phase II study including only patients on whom a decision to conduct radiofrequency ablation (RFA) has already been made. The primary objective of this study assess if quality of life was improved by RFA as assessed at baseline, 3 and potentially 6 and 12 months following RFA for the benign lesions.

RFA is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using an electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.

RF ablation is an alternative for local tumor control when other treatments (surgery, radiotherapy or chemotherapy) are not feasible (less effective or at higher risk). Thermal ablation at times is the only remaining alternative for patient cure, prolonged survival or palliation. Cryotherapy, and microwave, laser and focused ultrasound are alternative thermal ablation techniques used in adults but there has been no experience in children with these alternative methods.

To be eligible for this study, patients must have acquired lesions at \< 21 years of age (central nervous system lesions are excluded from this study). Study participants will have the RFA procedure performed at Seattle Children's and will have follow-up evaluations at various time points post-RFA.

Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood

Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood: A Phase II Study

Seattle Children's Hospital

Fredric A. Hoffer MD FAAP, FSIR

Gemcitabine

Histamine Antagonists

Histamine H1 Antagonists

Histamine H2 Antagonists

Antimetabolites

Cabazitaxel and gemcitabine on Day 1 then gemcitabine alone on Day 8 every 3 weeks until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision.

On Day 1, cabazitaxel was given either first followed by gemcitabine (part 1a) or after gemcitabine with 1 hour gap between the two infusions (part 1b). Required premedication with antihistamine, corticosteroid and H2 antagonist was administered intravenously 30 minutes before each dose of cabazitaxel.

Pharmaceutical form: 60 mg/1.5 ml concentrate solution for infusion

Route of administration: Intravenous infusion over 60 minutes

Dosage:

* Study part 1: 15, 20 or 25 mg/m\^2 according to pre-defined dose escalation schedule
* Study part 2: MTD as determined in Study part 1

cabazitaxel

Pharmaceutical form: According to United States Package Insert (USPI)

Route of administration: Intravenous infusion over 30 minutes

Dosage:

* Study part 1: 700, 900 or 1000 mg/m\^2 according to pre-defined dose escalation schedule
* Study part 2: MTD as determined in Study part 1.

gemcitabine

Primary Objectives:

* Study part 1: To determine the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLTs) of cabazitaxel administered as a 1-hour infusion in combination with gemcitabine, every 3 weeks in patients with advanced solid malignancies.
* Study part 2: To determine the antitumor activity of cabazitaxel in combination with gemcitabine, in an additional extended cohort of 15 patients with advanced solid malignancies treated with the defined MTD, as assessed by objective response rate (ORR) according to the revised guideline for Response Evaluation Criteria in Solid Tumours (RECIST 1.1 criteria).

Secondary Objectives:

* To assess the safety profile of the combination regimen of cabazitaxel with gemcitabine.
* To assess the pharmacokinetics (PK) of cabazitaxel, gemcitabine and its metabolite 2',2' difluorodeoxyuridine (dFdU) when given in combination.
* To determine Time to Progression (TTP), Objective Response Rate (ORR), and Duration of Response (DR), in the extended cohort of patients treated at the MTD in Part 2 of the study and the patients who received the MTD in Part 1 component.

For study part 1, dose levels were to be escalated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT during the first 3 weeks of treatment. There was no further dose escalation when this dose was achieved. The MTD was defined as the highest dose at which 0 or 1 of 3 to 6 patients, respectively, experienced DLT during the first 3 weeks of treatment.

The study consisted of a screening phase (maximum length of 21-day), a treatment phase with 21-day treatment cycles and a 30-day follow-up visit after the last dose of study medication.

The cut-off date for study part 1 was when last participant completed the first treatment cycle and the subsequent 30 days follow-up.

The cut off date for study part 2 was when all participants experienced disease progression, unacceptable toxicity, consent withdrawal or the last participant had completed 26 weeks or 6 cycles on study treatment, whichever came first.

Participants could continue to be treated on study as long as they were benefiting from study treatment and had not met study withdrawal criteria. After withdrawal from study treatment, further treatment, if any, was at the discretion of the Investigator.

Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor

A Dose-Escalation, Single Arm, Combination Study of Cabazitaxel With Gemcitabine to Determine The Safety, And Pharmacokinetics In Subjects With Advanced Solid Malignancies

Dose Limiting Toxicities (DLTs) were defined as clinical adverse events (AE) or laboratory abnormalities considered drug-related as assessed by the Investigator or Sponsor, and achieving a Common Terminology Criteria for Adverse Events v3.0 (CTCAE) severity rating of severe (3) or life-threatening (4).

Objective response was defined as a confirmed complete response (CR) or a confirmed partial response (PR) during the treatment period, based on RECIST 1.1, as assessed by the Investigator.

CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.

The objective response rate (ORR) was to be calculated as the proportion of participants with confirmed objective response relative to the total number of participants in the analysis population. Due to the inability to determine MTD during the study part 1, the analysis was not performed.

Time to progression (TTP) was defined as the time from first treatment administration to first documentation of RECIST-defined objective tumor progression (\>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of \>=1 new lesion and/or unequivocal progression of existing non-target lesions).

Median TTP was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed.

Duration of Response (DR) was defined as the time from the first documentation of RECIST-defined objective tumor response to the first documentation of RECIST-defined objective tumor progression or death.

Median DR was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed.

Summary of participants with adverse events (AEs) according to severity and relationship to study drug as assessed by the investigator. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used to grade the severity of AE.

Treatment-emergent adverse events (TEAEs) are AEs that occurred or worsened from start of treatment up to 30 days after treatment ceased.

NCI CTCAE v.3.0 grade 3 =severe and grade 4= life-threatening or disabling.

Blood samples for cabazitaxel assay were collected during cycle 1 and cabazitaxel plasma concentrations were determined using a validated liquid chromatography with tandem mass spectometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 1 ng/mL.

Pharmacokinetic (PK) parameters were calculated from plasma concentrations using non-compartmental analysis.

Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 0 to the last measurable concentration at time t.

Area under the plasma concentration versus time curve extrapolated to infinity

Blood samples for gemcitabine assay were collected on Day 1 of cycle 1 at the following timepoints:

* Cabazitaxel + Gemcitabine: prior the start of cabazitaxel infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of gemcitabine infusion;
* Gemcitabine + cabazitaxel: prior the start of gemcitabine infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of cabazitaxel infusion;

Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.

PK parameters were calculated from plasma concentrations using non-compartmental analysis.

Blood samples for gemcitabine assay were collected on Day 8 of cycle 1 at the following timepoints:

* Cabazitaxel + Gemcitabine: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of infusion;
* Gemcitabine + cabazitaxel: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of infusion;

Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.

PK parameters were calculated from plasma concentrations using non-compartmental analysis.

Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).

2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.

PK parameters were calculated from plasma concentrations using non-compartmental analysis.

Ratio Day 1/Day 8 for AUClast and AUC were calculated to assess the effect of cabazitaxel on gemcitabine exposure.

Cabazitaxel 20 mg/m\^2 IV followed by gemcitabine 1000 mg/m\^2 IV on Day 1 then, gemcitabine 1000 mg/m\^2 IV on Day 8

21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision

Cabazitaxel + Gemcitabine Dose Level 0

Cabazitaxel 15 mg/m\^2 IV followed by gemcitabine 900 mg/m\^2 IV on Day 1 then, gemcitabine 900 mg/m\^2 IV on Day 8

21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision

Cabazitaxel + Gemcitabine Dose Level -1

Cabazitaxel 15 mg/m\^2 IV followed by gemcitabine 700 mg/m\^2 IV on Day 1 then, gemcitabine 700 mg/m\^2 IV on Day 8

21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision

Cabazitaxel + Gemcitabine Dose Level -2

Gemcitabine 700 mg/m\^2 IV followed by cabazitaxel 15 mg/m\^2 IV on Day 1 then, gemcitabine 700 mg/m\^2 IV on Day 8

21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision

Gemcitabine + Cabazitaxel Dose Level 0

Part 1: Cabazitaxel + Gemcitabine Dose Level 0

Part 1: Cabazitaxel + Gemcitabine Dose Level -1

Part 1: Cabazitaxel + Gemcitabine Dose Level -2

Part 1: Gemcitabine + Cabazitaxel Dose Level 0

Age Continuous

Asian/Oriental

Black

Caucasian/White

Other

Race/Ethnicity, Customized

Body Surface Area

ECOG criteria:

* 0: Fully active
* 1: Ambulatory, carry out work of a light or sedentary nature
* 2: Ambulatory, capable of all selfcare
* 3: Capable of limited selfcare, confined to bed or chair more than 50% of waking hours
* 4: Completely disabled, no selfcare, totally confined to bed or chair
* 5: Dead

Eastern Cooperative Oncology Group (ECOG) Performance Status

Bladder

Colon

Head/neck

Lung

Muscle/soft tissue

Ovaries

Pancreas

Pelvis

Prostate

Skin

Primary Tumor Site

Adenocarcinoma

Squamous cell carcinoma

Histological Type

Stage I

Stage II

Stage III

Stage IV

Unknown

Cancer staging is on a scale of I-IV with higher numbers indicating an increase in progression of the disease.

Stage I: cancers are localized to one part of the body. Stage II: cancers are early locally advanced. Stage III: cancers are late locally advanced. Stage IV: cancers have often metastasized, or spread to other organs or throughout the body.

Stage at Diagnosis

Number of Organs Involved

Pharmacokinetic results need to be confirmed due to the limited data available.

Trial Transparency Team

DLT population: All participants who completed assessments for DLT evaluation for Cycle 1 and either:

* received study treatment during Cycle 1 and had DLT or
* did not have DLT and received a full dose of study treatment (no delay/reduction) during Cycle 1 and did not receive hematopoietic growth factors.

Participants With Dose Limiting Toxicities During Dose Escalation

Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1

21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision

Cabazitaxel + Gemcitabine MTD

Time To Progression With MTD

Duration of Response With MTD

Any AE

Any TEAE

- Drug-related TEAE

Grade 3-4 TEAE

- Grade 3-4 drug-related TEAE

Serious TEAE

- Drug-related serious TEAE

AE leading to drug withdrawn

- Drug-related AE leading to drug withdrawn

AE leading to death

AE leading to dose reduction

AE leading to dose delay

all treated (AT) population: All enrolled participants who received at least 1 part of a dose of study treatment

Participants With Adverse Events

Complete response

Partial response

Stable disease

Progressive disease

Not evaluable

Participant Best response was assessed by investigator using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1:

* Complete response (CR): Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm:
* Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion;
* Progressive disease (PD): \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of \>=1 new lesion and/or unequivocal progression of existing non-target lesions;
* Stable disease (SD): not a CR, PR or PD.

all treated (AT) population: All enrolled participants who received at least 1 part of a dose of study treatment.

Participant Best Response as Per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

PK population: All enrolled participants who received at least 1 part of a dose of study treatment and had at least 1 post treatment analyzable PK sample, and with no prohibited concomitant medications

Pharmacokinetic of Cabazitaxel on Cycle 1: Maximum Plasma Concentration Observed (Cmax)

Pharmacokinetic of Cabazitaxel on Cycle 1: Time to Maximum Concentration (Tmax)

Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)

PK population as previously defined. Six participants' assays could not be used for AUC.

Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve (AUC)

Pharmacokinetic of Cabazitaxel on Cycle 1: Terminal Half-life (t1/2z)

PK population as previously defined. Six participants' assays could not be used for CL.

Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance (CL)

PK population as previously defined. One participant's assay could not be used for Vss.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oxygen Measurements in Subcutaneous Tumors by EPR Oximetry Using OxyChip	NCT02706197	Neoplasms, Beni... Neoplasms, Mali...	OxyChip	18 Years -	Dartmouth-Hitchcock Medical Center
Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors	NCT01193595	Neoplasms, Mali...	Ombrabulin (AVE... bevacizumab	18 Years -	Sanofi
Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood	NCT00868647	Neoplasms, Beni... Neoplasms, Mali...	Radiofrequency ...	-	Seattle Children's Hospital
Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor	NCT01001221	Neoplasms, Mali...	cabazitaxel gemcitabine	18 Years -	Sanofi
Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors	NCT01193595	Neoplasms, Mali...	Ombrabulin (AVE... bevacizumab	18 Years -	Sanofi
Effect of Cabazitaxel on the QTc Interval in Cancer Patients	NCT01087021	Neoplasms, Mali...	Cabazitaxel (XR...	18 Years -	Sanofi
A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor	NCT01063946	Neoplasms, Mali...	Ombrabulin (AVE...	18 Years -	Sanofi
A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor	NCT01063946	Neoplasms, Mali...	Ombrabulin (AVE...	18 Years -	Sanofi
EPR Tumor Oximetry With CE India Ink	NCT03321903	Neoplasms, Mali... Breast Neoplasm Carcinoma, Basa... Carcinoma, Squa... Melanoma Skin Neoplasm Head and Neck N...	Carlo Erba Ink ... EPR Oximetry Me...	18 Years -	Dartmouth-Hitchcock Medical Center
A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor	NCT01063946	Neoplasms, Mali...	Ombrabulin (AVE...	18 Years -	Sanofi
EPR Tumor Oximetry With CE India Ink	NCT03321903	Neoplasms, Mali... Breast Neoplasm Carcinoma, Basa... Carcinoma, Squa... Melanoma Skin Neoplasm Head and Neck N...	Carlo Erba Ink ... EPR Oximetry Me...	18 Years -	Dartmouth-Hitchcock Medical Center

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