Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Taxane

Alkylating Agents

Antimitotic Agents

Tubulin Modulators

BIIB022 in Combination with Paclitaxel and Carboplatin

Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin

BIIB022 With Paclitaxel and Carboplatin

The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.

A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer

A Phase 1b, Open-Label, Dose-Escalation Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer

Biogen

Therese Senta-McMillian, Clinical Team Manager

Nervous System Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Brain Neoplasms

Neuroblastoma

Sarcoma

Liver Neoplasms

Wilms Tumor

Sarcoma, Ewing

Rhabdomyosarcoma

Soft Tissue Sarcoma

Wilms' Tumor

Ewing Sarcoma

Trabectedin

Antineoplastic Agents, Alkylating

Trabectedin (ecteinascidin-743, ET-743, YONDELIS [R])

Howard A Fine, M.D.

Background:

* Trabectedin is an experimental drug that kills some cancer cells in the laboratory and in mice by interfering with genetic material (DNA) in cancer cells.
* In some adult patients with cancer who received trabectedin, tumors grew slower or shrank.

Objectives:

* To determine a dose of trabectedin that can be given safely to children and adolescents as a 24-hour continuous infusion through a vein.
* To determine the side effects of trabectedin in children and adolescents.
* To study how the body handles trabectedin by measuring the amount of the drug in the bloodstream over time after a dose is given.
* To measure the effect of trabectedin on DNA in white blood cells.
* To determine if an individual's tumor cells have a specific proteins involved in DNA repair and if a pattern of genes can be identified in tumor samples that might help explain why trabectedin reduces tumors in some individuals and not others.
* To study genetic factors that may influence the way the body handles trabectedin.
* To see if trabectedin is beneficial in certain types of cancer.

Eligibility:

-Children between 4 year and 17 years of age with tumors that recur or no longer respond to standard treatment.

Design:

* Patients receive trabectedin as a 24-hour continuous infusion repeated every 21 days. The first three children entering the study receive a dose of 1.1 mg/m2. Subsequent groups of up to six patients receive higher doses (1.5 mg/m2 and 1.7 mg/m2) as long as the preceding dose is well tolerated. Patients enrolled at the lowest dose level may have their dose increased to the next level if they tolerated the lower dose well. Treatment may continue as long as the cancer does not worsen and the treatment is tolerated.
* Patients have blood drawn on days 1, 2, 3, 4, 5 and 7 of the first treatment cycle to study how the body handles trabectedin.
* A tumor sample obtained from a prior surgery or biopsy is examined for proteins involved in DNA repair.
* A blood sample is drawn to look for genetic factors that may influence how the body handles trabectedin.
* Patients have periodic physical examinations and blood tests. MRI or CT scans are done before starting therapy and after every two treatment cycles to evaluate the tumor.

Background:

Trabectedin (ET-743) is a natural product derived from the marine tunicate Ecteinascidia turbinata. It binds to the minor groove of DNA and interacts with various transcription factors resulting in cell cycle arrest. It also inhibits transcription coupled nucleotide excision repair system inducing lethal DNA strand breaks.

In preclinical and clinical studies, trabectedin has been found to be active in many soft tissue sarcomas including leiomyosarcoma, synovial cell sarcoma, neuroblastoma, rhabdomyosarcoma, melanoma, breast, ovarian, non-small cell lung, renal and prostate carcinoma.

In adult phase I and phase II studies, trabectedin has been well-tolerated up to dose levels of 1.9mg/m(2)/dose with the most common toxicities being fatigue, neutropenia, and reversible transaminase elevations. Objective responses were seen at doses equal to or greater than 1.5mg/m(2)/dose. Trabectedin 1.5mg/m(2) administered as a 24-hour continuous intravenous infusion is the recommended dose and schedule in adults.

A pediatric phase I study of trabectedin administered as a 3-hour infusion has been completed in the Children's Oncology Group. The maximum tolerated dose was 1.1 mg/m(2). Dose limiting toxicity was reversible elevation of hepatic transaminases.

Objectives:

Determine the maximum tolerated dose (MTD) of trabectedin administered as a 24-hour continuous infusion in children and adolescents with relapsed or refractory solid tumors.

Define the toxicity profile of trabectedin administered as a 24-hr infusion in children and adolescents.

Describe the pharmacokinetics of trabectedin administered as a 24-hr infusion in children and adolescents.

Quantify double strand DNA breaks in peripheral blood mononuclear cells of patients receiving trabectedin.

Evaluate archival formalin fixed paraffin embedded tumor tissue, when available from prior biopsies or surgical procedures, for the expression of the nucleotide excision repair proteins and genomic instability markers (histone gamma-H2AX, phospho-ATM, phospho-Chk2) by immunohistochemistry

Molecular characterization of DNA repair genes and correlation to outcome using mRNA isolated from microdissected archival formalin fixed, paraffin embedded tumor sections.

Study the pharmacogenetics of host DNA repair proteins and drug metabolizing enzymes to explore the impact of host factors on trabectedin toxicity.

Eligibility:

Children greater than or equal to 4 years and less than 17 years of age with relapsed or refractory solid tumors.

Design:

Patients will receive trabectedin as a 24-hour continuous infusion repeated every 21 days. The starting dose level is 1.1mg/m(2)/dose with escalations to 1.5mg/m(2)/dose and 1.7mg/m(2)/dose.

All patients will receive dexamethasone pretreatment and growth factor support with filgrastim or pegfilgrastim.

The definition of dose-limiting hepatic toxicity will be identical to the definition used in phase I trials in adults on the same dosing schedule.

Pharmacokinetic analysis will be performed on days 1, 2, 3, 4, 5 and 7 of the first treatment cycle.

Three to six patients will be enrolled at the first dose level and up to 6 patients will be enrolled on subsequent dose levels. Dose escalation will be based on tolerability of trabectedin at the prior dose level. For patients enrolled at dose level 1 (1.1mg/m(2)), intrapatient dose escalation to dose level 2 (1.5mg/m(2)) will be allowed with subsequent cycles if no dose limiting toxicities occurred at the lower dose level. Total accrual will be up to 24 patients.

Tabectedin to Treat Children and Adolescents With Cancer

A Phase I Trial and Pharmacokinetic Study of Trabectedin (YONDELIS [R], ET-743) in Children and Adolescents With Relapsed or Refractory Solid Tumors

National Cancer Institute (NCI)

Brigitte C. Widemann, M.D./National Cancer Institute

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Batracylin

Shivaani Kummar, M.D.

Background:

* Batracylin advanced through the National Cancer Institute (NCI) drug development pipeline until its evaluation at Stage 3 on July 1989, It was then proposed for a phase I investigation based on its activity against as TOPO II inhibitor in s.c. mouse colon 38, PANC03, COLO9, and cisplatin- and doxorubicin-resistant P388 tumors.
* IND-directed oral toxicology studies indicated interspecies variation in toxicity. Rats were found to be highly sensitive to batracylin. Ames et al showed that the interspecies variation in toxicity was consistent with the pattern of metabolism of the compound by N-acetyltransferase 2 (NAT2) to the acetylated form, N-Ac-batracylin, (a highly toxic molecule)
* We hypothesize that batracylin can be administered safely in slow acetylator NAT2 genotype patients and can be rapidly evaluated for its potential as a tumor-suppressing agent.

Objectives:

* Define the maximum tolerated dose, dose-limiting toxicities, and toxicity profile associated with the oral administration of batracylin daily x7 consecutive days, repeated every 28 days in patients with solid tumors and lymphomas.
* Define the pharmacokinetics of oral batracylin administered daily x7 consecutive days every 28 days.
* Obtain preliminary evidence of anti-tumor activity of batracylin in patients with solid tumors or lymphoma.
* Correlate polymorphisms in slow acetylators NAT2 genotypes (NAT2 5, NAT2 6, NAT2 7, and NAT2 14) with pharmacokinetics results.
* Evaluate the inter-subject variability and toxicity ratio, (N-Ac-Batra) / (batracylin).
* Evaluate the effect of batracylin treatment on gamma-H2AX levels in tumor biopsies.

Eligibility:

* Patients must have a slow acetylator NAT2 genotype defined as NAT2 5, NAT2 6, NAT2 7, or NAT2 14.
* Patients with advanced, histologically confirmed malignancies refractory to standard therapy, or those for whom no standard therapy exists.
* Patients should have adequate liver, renal, and bone marrow function.

Study Design:

* In accordance with the accelerated titration design 4B\[3\], dose levels will initially be increased at 100% increments, and one new patient per dose level will be treated according to a 4-week course.
* The accelerated phase ends when one patient experiences dose limiting toxicity (DLT) during the first course of treatment, or when two different patients experience grade 2, batracylin-related toxicity during the first course of treatment, or when the N-acetyl-batra AUC value reach 0.33 uM-Hour (i.e., the lower end of the range in the rat).
* When the first instance of grade 2 batracylin-related toxicity is observed, two additional patients must have been treated at that dose, or a higher dose (during any course), without experiencing moderate (grade 2) or worse (grade 3) toxicity, in order for the accelerated phase to continue.
* When the accelerated phase ends, the dose-escalation will revert to a more conservative, modified Fibonacci scheme with 40% dose-step increments, with at least 3 patients treated per dose level.

Background:

* Batracylin advanced through the National Cancer Institute (NCI) drug development pipeline until its evaluation at Stage 3 on July 1989, It was then proposed for a phase I investigation based on its activity against as TOPO II inhibitor in s.c. mouse colon 38, PANC03, COLO9, and cisplatin- and doxorubicin-resistant P388 tumors.
* IND-directed oral toxicology studies indicated interspecies variation in toxicity. Rats were found to be highly sensitive to batracylin. Ames et al showed that the interspecies variation in toxicity was consistent with the pattern of metabolism of the compound by N-acetyltransferase 2 (NAT2) to the acetylated form, N-Ac-batracylin, (a highly toxic molecule)
* We hypothesize that batracylin can be administered safely in slow acetylator NAT2 genotype patients and can be rapidly evaluated for its potential as a tumor-suppressing agent.

Objectives:

* Define the maximum tolerated dose, dose-limiting toxicities, and toxicity profile associated with the oral administration of batracylin daily for 7 consecutive days, repeated every 28 days in patients with solid tumors and lymphomas.
* Define the pharmacokinetics of oral batracylin administered daily for 7 consecutive days every 28 days.
* Obtain preliminary evidence of anti-tumor activity of batracylin in patients with solid tumors or lymphoma.
* Correlate polymorphisms in slow acetylators NAT2 genotypes (NAT2 5, NAT2 6, NAT2 7, and NAT2 14) with pharmacokinetics results.
* Evaluate the inter-subject variability and toxicity ratio, (N-Ac-Batra) / (batracylin).
* Evaluate the effect of batracylin treatment on gamma-H2AX levels in tumor biopsies.

Eligibility:

* Patients must have a slow acetylator NAT2 genotype defined as NAT2 5, NAT2 6, NAT2 7, or NAT2 14.
* Patients with advanced, histologically confirmed malignancies refractory to standard therapy, or those for whom no standard therapy exists.
* Patients should have adequate liver, renal, and bone marrow function.

Study Design:

* In accordance with the accelerated titration design 4B\[3\], dose levels will initially be increased at 100% increments, and one new patient per dose level will be treated according to a 4-week course.
* The accelerated phase ends when one patient experiences dose limiting toxicity (DLT) during the first course of treatment, or when two different patients experience grade 2, batracylin-related toxicity during the first course of treatment, or when the N-acetyl-batra AUC value reach 0.33 uM-Hour (i.e., the lower end of the range in the rat).
* When the first instance of grade 2 batracylin-related toxicity is observed, two additional patients must have been treated at that dose, or a higher dose (during any course), without experiencing moderate (grade 2) or worse (grade 3) toxicity, in order for the accelerated phase to continue.
* When the accelerated phase ends, the dose-escalation will revert to a more conservative, modified Fibonacci scheme with 40% dose-step increments, with at least 3 patients treated per dose level.

Safety of Batracylin in Patients With Solid Tumors and Lymphomas

A Phase I Study of Batracylin (NSC320846) in Subjects With Solid Tumors and Lymphomas

Adenocarcinoma

Pancreatic Diseases

Neoplasms, Glandular and Epithelial

Gemcitabine

Antimetabolites

Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily.

Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose. Cycles repeated every 28 days.

Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days.

Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily.

Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily.

Phase I: oral LDE225 (Sonidegib), 600mg daily.

Phase II Arm A: LDE225 at the recommended phase 2 dose on Days 1, 8 and 15. Cycles repeated every 28 days.

LDE225-600mg

Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.

Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days.

nab-paclitaxel

Phase I: oral LDE225 (Sonidegib), 400mg daily.

LDE225-400mg

Phase I: oral LDE225 (Sonidegib), 800mg daily.

LDE225-800mg

Ana De Jesus-Acosta, MD

This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine and nab-paclitaxel with an oral hedgehog inhibitor LDE225 (Sonidegib). The objective is to assess tolerability and the resection rate of patients with borderline resectable pancreatic adenocarcinoma who use this treatment.

The investigators propose treating 6-12 patients during the phase 1 portion and 40 patients in the phase 2 stage.

Phase 1 Stage:

Four cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with escalating doses (400mg, or 600mg, or 800mg) of LDE-225. After completion of neoadjuvant therapy, the subjects will receive combined chemotherapy and radiation. Then subjects who are eligible for resection will go ahead with surgery. Following resection, subjects will complete two additional cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 in combination with LDE-225.

Phase 2 Stage: In the Phase 2 stage the patients will be randomized to receive gemcitabine and nab-paclitaxel with or without the hedgehog inhibitor LDE225:

1. Arm A: Four cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose.
2. Arm B: Four cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m on days 1, 8 and 15.

After completion of neoadjuvant therapy, the subjects will receive combined chemotherapy and radiation. Then subjects who are eligible for resection will go ahead with surgery. Following resection, subjects will complete two additional cycles of the pre-surgical therapy.

Several correlative laboratory studies will be conducted during the course of this study. They were designed around the goals of providing us with a better understanding of how the stroma-tumor interaction and the intra-tumoral drug levels of gemcitabine are affected with the use of LDE-225. Two additional biopsies are required to participate in this study.

Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma

Phase 1/2 Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma.

Number of participants who tolerated the maximal dose of LDE-225 in combination with gemcitabine, nab-paclitaxel as neoadjuvant therapy in patients with borderline resectable pancreatic adenocarcinoma (PDA).

Number of participants with borderline resectable pancreatic adenocarcinoma (PDA) who undergo resection after therapy

Number of months alive from cycle 1, Day 1 until 5 years post-intervention or death, whichever comes first.

Number of participants who experienced complete response (CR) or partial response (PR), as defined by RECIST v1.0; where CR is a disappearance of all target lesions and PR is ≥30% reduction of target lesions.

Novartis Pharmaceuticals

The Skip Viragh Foundation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Only for eligible participants. There were no participants enrolled in Phase I: gem, nab-paclitaxel, and LDE225-400mg, Phase I: gem, nab-paclitaxel, and LDE225-800mg, Phase II Arm A, and Phase II Arm B because the study was terminated early

Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle with oral LDE225, 600mg.

Phase I, Gem, Nab-paclitaxel, and LDE225-600mg

Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle with oral LDE225, 400mg.

Phase I, Gem, Nab-paclitaxel, and LDE225-400mg

Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2o n days 1, 8, and 15 every 28 days cycle with oral LDE225, 800mg.

Phase I, Gem, Nab-paclitaxel, and LDE225-800mg

Phase II:

Arm A: Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase I dose. Cycles repeated every 28 days.

Phase II, Arm A: Gem, Nab-paclitaxel, and LDE 225

Phase II:

Arm B: Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days.

Phase II, Arm B: Gemcitabine and Nab-paclitaxel

Phase I:

Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with oral LDE225 600 mg daily

Phase I:

Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with oral LDE225 400 mg daily

Phase I:

Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with oral LDE225 800 mg daily

Phase II:

Arm A: Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose from Phase I. Cycles repeated every 28 days.

Total

Age, Continuous

Sex: Female, Male

Not Hispanic or Latino

Race/Ethnicity, Customized

All participants were enrolled in Phase 1, gem, nab-paclitaxel, and LDE225-600mg arm only. Other arms did not have any participants due to the study's early termination.

Dr. Ana De Jesus-Acosta

Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily.

Phase I: Gem, Nab-paclitaxel, and LDE225-600mg

Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily.

Phase I: Gem, Nab-paclitaxel, and LDE225-400mg

Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily.

Phase I: Gem, Nab-paclitaxel, and LDE225-800mg

This measure only applies to the Phase I arms. All 13 subjects participated in the Arm/group: Phase I: gem, nab-paclitaxel, and LDE225-600mg. There were no participants enrolled in other two Arm/group as the study was terminated.

Phase I - Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy as Measured by Number of Participants Who Tolerated the Maximal Dose of LDE-225

Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose. Cycles repeated every 28 days.

LDE225-600mg: Phase I: oral LDE225 (Sonidegib), 600mg daily.

Phase II Arm A: LDE225 at the recommended phase 2 dose on Days 1, 8 and 15. Cycles repeated every 28 days.

Gemcitabine: Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.

nab-paclitaxel: Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days.

LDE225-400mg: Phase I: oral LDE225 (Sonidegib), 400mg daily.

LDE225-800mg: Phase I: oral LDE225 (Sonidegib), 800mg daily.

Phase II-Arm A:Gem,Nab-paclitaxel,LDE225

Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days.

Gemcitabine: Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.

nab-paclitaxel: Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days.

Phase II-Arm B:Gem,Nab-paclitaxel

No data was collected to assess this outcome measure as the study was terminated before Phase II.

Phase II - Resection Rate of Two Preoperative Chemotherapy Regimens in Patients With Borderline Resectable PDA

Overall Survival

Overall Tumor Response as Determined by Number of Participants With Complete or Partial Response

Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily.

Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily.

Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer	NCT00970580	Non-Small Cell ...	BIIB022 With Pa...	18 Years -	Biogen
Tabectedin to Treat Children and Adolescents With Cancer	NCT01453283	Solid Tumors	Trabectedin (ec...	4 Years - 16 Years	National Institutes of Health Clinical Center (CC)
Safety of Batracylin in Patients With Solid Tumors and Lymphomas	NCT00450502	Neoplasms	Batracylin	18 Years -	National Institutes of Health Clinical Center (CC)
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer	NCT00970580	Non-Small Cell ...	BIIB022 With Pa...	18 Years -	Biogen
Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma	NCT01431794	Pancreatic Duct...	LDE225-600mg Gemcitabine nab-paclitaxel LDE225-400mg LDE225-800mg	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for cytotoxic

Every month we try and update this database with for cytotoxic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cytotoxic

Every month we try and update this database with for cytotoxic cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cytotoxic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.