Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Leukemia

Hyperuricemia

Preleukemia

Myelodysplastic Syndromes

Lymphoma

Tumor Lysis Syndrome

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

All Drugs and Chemicals

Antirheumatic Agents

Uric Acid

Allopurinol

Rasburicase

Antimetabolites

Enzyme Inhibitors

Antioxidants

Protective Agents

Rasburicase alone given as a single agent for 5 days

Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)

Oral allopurinol alone given as a single agent for 5 days

Rasburicase (SR29142)

International Clinical Development

This is a randomized, multi-center, open-label, parallel group study with three arms:

* Rasburicase alone
* Rasburicase followed by Allopurinol
* Allopurinol alone

The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome

Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 \<7.5 mg/dl.

Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values

Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined \<=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.

Sanofi

International Clinical Development, Clinical Study Director

Reported events are treatment emergent adverse events within the time frame mentioned above.

Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days

Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)

Rasburicase + Allopurinol

Allopurinol (300 mg/day) given alone as a single agent for 5 days

Total

<65 years

>=65 years

Age, Customized

Sex: Female, Male

Responder

Non-Responder

Plasma Uric Acid Responder

The analysis was performed on the modified ITT-population with an evaluation of plasma uric acid AUC.

Plasma Uric Acid

The analysis was performed on a subgroup of patients from the mITT-population with hyperuricemia immediately prior to the first dose of study drug.

Time to Uric Acid Control

Overall Study

Antineoplastic Agents

Temozolomide

Veliparib

Antineoplastic Agents, Alkylating

Alkylating Agents

Poly(ADP-ribose) Polymerase Inhibitors

Dose orally twice daily for 7 days, consecutively, every cycle

veliparib

Dose orally once daily for 5 days, consecutively, every cycle

Bhardwaj Dessai, MD

To evaluate the safety and tolerability of the veliparib/TMZ combination in subjects with solid tumors.

An extension study to evaluate the safety of veliparib in combination with temozolomide in subjects with solid tumors

To Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors

An Extension Study to Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors.

Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments

Abbott

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Lung Neoplasms

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Male Urogenital Diseases

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Trastuzumab

Ado-Trastuzumab Emtansine

Adenosine

Maytansine

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

Immunotoxins

Immunoconjugates

Immunologic Factors

Ado-trastuzumab emtansine is administered intravenously at 3.6 mg/kg every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.

ado-trastuzumab emtansine

Bob Li, MD

Gopakumar Iyer, MD

The purpose of this study is to find out what effects, a drug called ado-trastuzumab emtansine has on the patient and their cancer which is thought to be controlled by the abnormal HER2 gene.

Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers

A Phase 2 Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers

As soon as evaluations for each tumor assessment are completed, the Investigator should assess the patient's overall response (target plus non- target lesions) based on criteria and overall response algorithms as defined in RECIST version 1.1. Scans must be assessable for all evaluations.

Genentech, Inc.

Memorial Sloan Kettering Cancer Center

Pharmaceutical Solutions

SAR245408 taken every day in the morning: no eating 2 hours prior and 1 hour after dose; SAR256212 will be given weekly by IV infusion over 1 hour, right after the SAR245408 oral dose

Pharmaceutical form:solution

Route of administration: Intravenous

MM-121 (SAR256212)

Pharmaceutical form:tablet

Route of administration: oral

SAR245408

Clinical Sciences & Operations

Primary Objective:

* To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors.

Secondary Objectives:

* To characterize the global safety profile of SAR245408 in combination with SAR256212
* To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in combination
* To evaluate the objective response rate (ORR) and tumor volume change (for expansion cohort only)
* To determine the immunogenicity of SAR256212 as administered with SAR245408

There is a 28 day screening period followed by 28 day cycles (21 day cycle for the every three week dosing regimen, if used) . Patients will continue to receive SAR245408/SAR256212 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 60 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.

A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers

A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of SAR245408 Administered in Combination With SAR256212 in Patients With Solid Tumor Cancers

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome	NCT00230178	Tumor Lysis Syn... Cancer Hyperuricemia	Rasburicase (SR... Allopurinol	18 Years -	Sanofi
To Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors	NCT01193140	Solid Tumor Can...	veliparib Temozolomide	18 Years -	Abbott
Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers	NCT02675829	Solid Tumor Can... Lung Cancer Bladder Cancer Urinary Tract C...	ado-trastuzumab...	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers	NCT01436565	Solid Tumor Can...	MM-121 (SAR2562... SAR245408	18 Years -	Sanofi
Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers	NCT02675829	Solid Tumor Can... Lung Cancer Bladder Cancer Urinary Tract C...	ado-trastuzumab...	18 Years -	Memorial Sloan Kettering Cancer Center
To Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors	NCT01193140	Solid Tumor Can...	veliparib Temozolomide	18 Years -	Abbott

Spots Global Cancer Trial Database for solid tumor cancers