Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Ifosfamide

Isophosphamide mustard

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Four cycles ifosfamide 9 g/m2 and four cycles doxorubicin 80 mg/m2. Each cycle has a duration of 14 days.

Kjetil Boye, MD PhD

Tor-Christian Johannessen, MD

Nearly half of patients with high-grade, localized soft tissue sarcoma (STS) of extremities and trunk wall develop disease recurrence after local therapy. Adjuvant chemotherapy with ifosfamide and doxorubicin may improve long-term disease-free survival, but the benefit of adjuvant treatment is limited and predictive factors for treatment response are lacking. The aim of this study is to explore sequential treatment with ifosfamide and doxorubicin in a neoadjuvant setting and to investigate biomarkers predictive of treatment response.

Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma

Sequential Neoadjuvant Ifosfamide and Doxorubicin in Localized High-grade Soft Tissue Sarcoma of Extremities and Trunk Wall

To assess change from baseline in the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) scores during treatment

To investigate if the extent of the surgical procedure is changed due to neoadjuvant treatment

Partial or complete response using RECIST v1.1

Number and type of adverse events, serious adverse events, dose reductions and discontinuation due to toxicity

To investigate if TP53 mutations assessed by sequencing of tumor DNA predict response to high-dose alkylating chemotherapy and/or sequential doxorubicin monotherapy in STS

Haukeland University Hospital

Oslo University Hospital

Senior Consultant

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Trastuzumab

trastuzumab was administered concurrently with any anthracycline-containing adjuvant regimen

trastuzumab was administered sequentially to any anthracycline-containing adjuvant regimen

Trastuzumab will be administered concurrently with any anthracycline-containing regimen for breast cancer adjuvant chemotherapy. Trastuzumab will be given intravenously 8mg/kg loading dose, followed by 6mg/kg every 3 weeks for one year.

concurrent

Trastuzumab will be administered sequentially to any anthracycline-containing regimen for breast cancer adjuvant chemotherapy. Trastuzumab will be given intravenously 8mg/kg loading dose, followed by 6mg/kg every 3 weeks for one year.

sequential

Sun Qiang, Master

Most of the published data support the preferential use of an anthracycline-containing adjuvant regimen for individuals with HER2-positive tumors. Concurrent anthracyclines and trastuzumab, however, are contraindicated due to the observation of unacceptably high rates of cardiotoxicity in a large randomized trial in the metastatic setting. However, in neoadjuvant setting, trastuzumab concurrently with an anthracycline-containing chemotherapy regimen had shown high pathological complete response (pCR) and very low cardiotoxicity. All large adjuvant trials have evaluated only the sequential strategy of administering anthracyclines and trastuzumab. The safety and efficacy of trastuzumab concurrently with an anthracycline-containing chemotherapy regimen has never been evaluated in adjuvant setting. Given the similar patients characteristics, the investigators hypothesize that trastuzumab concurrently with an anthracycline-containing chemotherapy regimen would not increase cardiotoxicity but efficacy.

Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer

Safety and Efficacy Evaluation of Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer

the heart failure rate will be compared at 2 years, and left ventricular ejection fraction (LVEF) changes will be monitored during 3, 6, 9, 12, 24 months after firs dose of drug administration

local recurrence, regional recurrence, contralateral breast recurrence, distant metastasis, death

Peking Union Medical College Hospital

Gemcitabine

Vinorelbine

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Gemcitabine monotherapy followed by Vinorelbine monotherapy:

-Gemcitabine: 1,200 mg/m2, intravenously, on day 1 and day 8 in 3 week cycles. Vinorelbine: 30 mg/ m2, intravenously, on day 1 and day 8 in 3 week cycles.

Gemcitabine, 1,000mg/m2 and Vinorelbine, 25mg/m2, on day 1 and day 8, every 3 week cycles

Gemcitabine plus Vinorelbine

Sequential

Jungsil Ro, MD, PhD

To evaluate the overall response rate of gemcitabine and vinorelbine combination (GV) and gemcitabine followed by vinorelbine (G⇒V) when used as palliative therapy in patients with stage IV and recurrent breast cancer.

This is an open-label, randomized, two-arm, parallel group phase II study. Eligible patients will be randomized to each of the two treatment regimens, one of which is gemcitabine and vinorelbine combination therapy (Group A) and the other is gemcitabine monotherapy followed by vinorelbine monotherapy (Group B). Patients In group A monotherapy will receive gemcitabine and vinorelbine in combination, while patients in group B will receive gemcitabine monotherapy until the evidence of disease progression followed by vinorelbine. A total of 82 patients will be enrolled in this study. Patients will be randomized after stratified according to the number of prior chemotherapy including adjuvant chemotherapy and visceral disease. No maximum number of cycles is pre-determined. Patients may continue on study therapy until documented treatment failure.

Patients in group A who discontinue study therapy will proceed to the post-therapy follow-up phase of the study. Patients in group B who discontinue study therapy while treated with gemcitabine will proceed to receive vinorelbine on disease progression. Patients on vinorelbine who discontinue study therapy will proceed to the post-therapy follow-up phase of the study. Further treatment upon discontinuation of study therapy is at the discretion of the investigator.

A two arm, open label phase II study without control is appropriate for exploring the efficacy of gemcitabine with concurrent or sequential vinorelbine in this patient population and for evaluating and characterizing toxicities of two treatment approaches, qualitatively and quantitatively. The purpose of randomization in this phase II study is to diminish the possible impact of selection bias on treatment outcome and thus on interpretation of efficacy and safety data.

Phase II Study of Gemcitabine/Vinorelbine vs Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer

A Phase II Study of Gemcitabine in Combination With Vinorelbine vs. Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer

National Cancer Center, Korea

Jungsil Ro/MD, PhD

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

COVID-19

Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Mantle Cell Lymphoma

Gastrointestinal Agents

Amino Acids

Acalabrutinib

Rabeprazole

Tyrosine Kinase Inhibitors

Proton Pump Inhibitors

Protein Kinase Inhibitors

Tyrosine

Part 1: Participants will receive Treatment A (100 mg AT suspension in water via NG administration) in Period 1, Treatment B (100 mg acalabrutinib capsule suspension via NG administration) in Period 2, and Treatment C (100 mg AT suspension in water via NG administration plus 20 mg rabeprazole) in Period 3.

Part 2: Participants will receive Treatment D (100 mg AT suspension in water via NG administration) in Period 1 and Treatment A in Period 2.

Part 1: Participants will receive Treatment B in Period 1, Treatment A in Period 2, and Treatment C in Period 3.

Part 2: Participants will receive Treatment A in Period 1 and Treatment D in Period 2.

Participants will receive 100 mg AT suspension in water via NG tube.

Acalabrutinib Treatment A

Participants will receive 100 mg acalabrutinib capsule suspension via NG tube.

Acalabrutinib Treatment B

Participants will receive 100 mg AT suspension in water via NG administration plus 20 mg rabeprazole.

Acalabrutinib Treatment C

Participants will receive 100 mg AT orally.

Acalabrutinib Treatment D

Dr. Rainard Fuhr

This Phase 1 study is being conducted to support the clinical development of acalabrutinib in hospitalized patients who are unable to swallow acalabrutinib tablet or capsule due to respiratory failure, eg, they may require endotracheal intubation for ventilator support and nasogastric (NG) tube placement, and it is important to have a clinically acceptable method to administer acalabrutinib via NG tube.

Part 1 of the study is designed to evaluate relative bioavailability by comparing the pharmacokinetic (PK) of AT suspension in water administered via NG tube with the PK of acalabrutinib capsule suspension in flat COCA-COLA administered via NG tube. Additionally, the PPI effect will be evaluated by comparing the PK of AT suspension in water administered via NG tube plus rabeprazole with the PK of AT suspension in water administered via NG tube.

Part 2 of the study is designed to evaluate the effect of NG administration on AT by comparing the PK of AT suspension in water administered via NG tube with the PK of AT orally administered with water.

Part 1 of the study comprises:

* A screening period of maximum 28 days.
* Three treatment periods during which subjects will reside in the Clinical Unit from Day -2, Treatment Period 1 until at least 48 hours after dosing on Day 1, Treatment Period 3, ie, subjects will be discharged the morning of Day 3, Treatment Period 3.
* A Follow-up Visit within 7 to 10 days after the last dose of acalabrutinib.

There will be a minimum washout period of 4 days between treatment periods. Up to 20 subjects will be included to ensure at least 16 subjects are evaluable. Subjects will be randomized to one of 2 treatment sequences (ABC, BAC) and each subject will receive single doses of 3 treatments under fasted conditions.

Part 2 of the study comprises:

* A screening period of maximum 28 days.
* Two treatment periods during which subjects will reside in the Clinical Unit from Day -2, Treatment Period 1 until at least 48 hours after dosing on Day 1, Treatment Period 2, ie, subjects will be discharged the morning of Day 3, Treatment Period 2.
* A Follow-up Visit within 7 to 10 days after the last dose of acalabrutinib.

There will be a minimum washout period of 4 days between treatment periods. Up to 20 subjects will be included to ensure at least 16 subjects are evaluable. Subjects will be randomized to one of 2 treatment sequences (DA, AD) and each subject will receive single doses of 2 treatments under fasted conditions.

A Study in Healthy Subjects to Assess Bioavailability (Proportion of a Drug Which Enters the Circulation to Have an Active Effect) of Acalabrutinib Tablet and Protonpump Inhibitor Effect (Members of a Class of Medications That Inhibits in Gastric Acid Production) for Rabeprazole

A 2-Part, Phase I, Open-label, Single-dose, Sequential, Randomized, Crossover Study of Acalabrutinib Tablet Suspension Delivered Via Nasogastric Tube in Healthy Subjects to Evaluate Relative Bioavailability and Proton-pump Inhibitor (Rabeprazole) Effect

Qualified researchers can request access to anonymized individual patient-level data from

AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Part 1: Comparison of AUCinf of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of AUCinf of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: Comparison of AUClast of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of AUClast of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: Comparison of Cmax of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of Cmax of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: Comparison of AUC0-24 of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of AUC0-24 of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: Comparison of tmax of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of tmax of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: Comparison of t1/2 of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of t1/2 of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: Comparison of MRT of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of MRT of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: Comparison of λz of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of λz of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: Comparison of CL/F of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of CL/F of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: Comparison of Vz/F of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of Vz/F of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: Comparison of M:P\[AUC\] of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of M:P\[AUC\] of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: Comparison of M:P\[Cmax\] of acalabrutinib and its metabolite (ACP-5862) following NG administration of AT suspension versus NG administration of acalabrutinib capsule suspension and to evaluate the effect of PPI (rabeprazole) on acalabrutinib and ACP-5862 PK profiles following NG administration of AT suspension.

Part 2: Comparison of M:P\[Cmax\] of acalabrutinib and ACP 5862 following NG administration of AT suspension versus oral administration of AT.

Part 1: To evaluate the safety and tolerability of AT suspension administered via NG tube and to evaluate the safety and tolerability of AT suspension via NG tube when co-administered with rabeprazole.

Part 2: To evaluate the safety and tolerability of AT, administered orally.

Parexel

AstraZeneca

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

Micronutrients

Mineral

Temozolomide

Angiogenesis Inhibitors

Copper

Tetrathiomolybdate

Chelating Agents

Growth Inhibitors

Copper Supplement

ATN-224

Gilad Gordon, MD

This is a multicenter, randomized, phase II study to evaluate the safety and efficacy of oral ATN-224 plus temozolomide in patients with advanced melanoma. Patients will be randomized (1:1) between temozolomide and ATN-224 and temozolomide followed by ATN-224. Patients assigned to the sequential treatment group will receive temozolomide until progression of disease is documented and then receive ATN-224 as a single agent until documentation of progression of disease using the last tumor assessment on temozolomide therapy as the baseline assessment.

According to the National Cancer Institute PDQ database, advanced melanoma is refractory to most standard systemic therapy, and all newly diagnosed patients should be considered candidates for clinical trials. Although advanced melanoma is relatively resistant to therapy, several biologic response modifiers and cytotoxic agents have been reported to produce objective responses. Once melanoma is metastatic, treatments are palliative rather than curative. In spite of many attempts at multimodality therapy, the prognosis in this disease remains poor. Further agents are needed if progress is to be made with melanoma treatment.

ATN-224 is an orally active, small molecule that has been shown in cellular and animal models to be antiangiogenic and to have activity against melanoma cell lines. Clinical studies with a similar agent (ammonium tetrathiomolybdate) indicate that the agent can be administered continuously on a daily basis for years in some patients. ATN-224 has the potential to affect the progression of melanoma by mechanisms that include both antiangiogenic and antitumor pathways. Temozolomide, a commonly used agent for melanoma, also has a tolerable profile.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma	NCT04776525	Soft Tissue Sar...	Ifosfamide Doxorubicin	18 Years -	Oslo University Hospital
Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer	NCT01413828	Breast Cancer	concurrent sequential	18 Years - 70 Years	Peking Union Medical College Hospital
Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma	NCT04776525	Soft Tissue Sar...	Ifosfamide Doxorubicin	18 Years -	Oslo University Hospital
Phase II Study of Gemcitabine/Vinorelbine vs Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer	NCT00532623	Metastatic Brea...	Gemcitabine plu... Sequential	18 Years -	National Cancer Center, Korea
A Study in Healthy Subjects to Assess Bioavailability (Proportion of a Drug Which Enters the Circulation to Have an Active Effect) of Acalabrutinib Tablet and Protonpump Inhibitor Effect (Members of a Class of Medications That Inhibits in Gastric Acid Production) for Rabeprazole	NCT04564040	Mantle Cell Lym... COVID-19	Acalabrutinib T... Acalabrutinib T... Acalabrutinib T... Acalabrutinib T...	18 Years - 55 Years	AstraZeneca
Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer	NCT01413828	Breast Cancer	concurrent sequential	18 Years - 70 Years	Peking Union Medical College Hospital
Randomized Trial of ATN-224 and Temozolomide in Advanced Melanoma	NCT00383851	Melanoma	ATN-224 Temozolomide	18 Years -	Attenuon
Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma	NCT04776525	Soft Tissue Sar...	Ifosfamide Doxorubicin	18 Years -	Oslo University Hospital
A Study in Healthy Subjects to Assess Bioavailability (Proportion of a Drug Which Enters the Circulation to Have an Active Effect) of Acalabrutinib Tablet and Protonpump Inhibitor Effect (Members of a Class of Medications That Inhibits in Gastric Acid Production) for Rabeprazole	NCT04564040	Mantle Cell Lym... COVID-19	Acalabrutinib T... Acalabrutinib T... Acalabrutinib T... Acalabrutinib T...	18 Years - 55 Years	AstraZeneca

Spots Global Cancer Trial Database for sequential

Every month we try and update this database with for sequential 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 sequential

Every month we try and update this database with for sequential 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 sequential 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.