Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Cholangiocarcinoma

Breast Neoplasms

Pancreatic Neoplasms

Stomach Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Multiple Myeloma

Neoplasms, Plasma Cell

Liver Neoplasms

Choriocarcinoma

Pancreatic Cancer

Ovarian Cancer

Bile Duct Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Herbal and Botanical

Liver Extracts

Cediranib

Saracatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Cola

oral tablet multiple ascending doses 20, 30 or 45 mg

AZD2171

oral tablet multiple ascending doses 125 mg or 175 mg

AZD0530

Jane Roberston

Tanja Trarbach, MD

The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.

Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours

Phase I, Open-Label Study To Assess the Safety, Tolerability and Pharmacokinetics of Daily Oral Doses of Cediranib (RECENTIN™;AZD2171) (20, 30 or 45mg) When Co-Administered With Daily Oral Doses of AZD0530 (125mg or 175mg) in Patients With Advanced Solid Tumours

AstraZeneca

Jane Robertson, MSD

Pharmaceutical Solutions

Antibodies

Immunoglobulins

Immunoglobulins, Intravenous

Immunologic Factors

0.1mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 0.1mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

0.3mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 0.3mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

1mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 1mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

3mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 3mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

6mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 6mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

10mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 10mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

BAT6026

BAT1308

Prachi Bhave, M.D, Ph.D

This is a multicenter, open-label, Phase 1 dose-escalation study of BAT6026, an OX40 monoclonal antibody, combined with the anti-PD-1 IgG4 monoclonal antibody BAT1308 in subjects with advanced solid tumours. After a screening period of up to 28 days, qualified subjects will be enrolled to receive their assigned dose regimen until disease progression or intolerable toxicity, withdrawal of consent, per Investigator decision, or end of study, whichever occurs first. The maximum treatment duration is 1 year. Subjects who remain on treatment in the absence of disease progression for more than 1 year may continue to receive study drug for the next cycle at the maximum of 2 years.

Although the success of immune checkpoints like PD-1/PD-L1 and CTLA-4 has provided more alternatives and benefit to cancer patients, there are still much unmet need in tumour patients. That is why novel immunomodulatory drugs with other mechanisms of action still needed to be developed and tested clinically. OX40 is a co-stimulatory immune checkpoint which is contrary to PD-1 or CTLA4. Similar to other TNFSF members, three OX40 molecules were clustered when binding to one OX40L ligand on activated APCs. The clustered OX40s then directly activate NF-kB, PI3K/PKB and NFAT signal pathways to activate CD4+ and CD8+T cells 9. Thus, antibody targeting OX40 should be an agonist antibody which can be crosslinked by FcyR of effector cells. As the mechanism and signal pathways mediated by OX40 to activate T cells are different from those mediated by PD-1 and CTLA-4, targeting on OX40 may provide different clinical benefit for patients than treating with PD-1 and CTLA-4 therapies.

To enhance activation on T cells, combination treatment with PD-1, PD-L1, or CTLA-4 antibodies is a feasible approach for anti-OX40 immunotherapy. The effect of combination treatment of BAT6026 with an anti-PD1 antibody, BAT1308, in mouse tumour model was examined in the in vivo pharmacology study. MC38 murine colon carcinoma cells were inoculated in PD-1/OX40-dual-humanized mice.

Therefore, besides exploration as a monotherapy, finding a combination agent(s) and a suitable indication(s) would also be an encouraging direction for clinical development of BAT6026.

Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients

A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6026 as Monotherapy and in Combination With BAT1308 in Patients With Advanced Solid Tumours

A DLT is defined as a toxicity occurring during the DLT observation period. Events clearly associated with the underlying disease, disease progression, a concomitant medication, or comorbidity should be excepted, and it should be considered to be at least possibly related to study drug as defined below

Grade 5 toxicity; Grade 4 anaemia; Grade 4 thrombocytopenia lasting ≥ 7 days ; Grade 3 thrombocytopenia if associated with clinically significant bleeding (≥ Grade 2 haemorrhage) or with requirement of transfusion of platelets; Grade 4 neutropenia for ≥ 7 days ; ≥ Grade 3 neutropenia associated with infection or febrile neutropenia

Any SAE that is judged by the PI or designee to be related to the study medication must be reported regardless of the amount of time since the last dose received. Follow-up information collected for any initial report of an SAE must also be reported to the Sponsor within 24 hours of receipt by the PI or designee.

Bio-Thera Solutions

20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8

cediranib (RECENTIN TM, AZD2171)

Jeannie Hou

Sun Yan, Prof

This study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.

The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and how the tumour responds to treatment with cediranib.

A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies

A Phase I, Randomised, Multi-centre, Open-label Study to Determine the Pharmacokinetics and Tolerability of Cediranib (RECENTIN™, AZD2171) Following a Single and Multiple Oral 20mg or 30 mg Doses in Chinese Patients With Advanced Solid Malignancies

Symptoms and General Pathology

Recurrence

Glioblastoma

Disease Attributes

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Lomustine

Antineoplastic Agents, Alkylating

Alkylating Agents

Lomustine Chemotherapy

Placebo Cediranib

Jane Robertson

Tracy Batchelor, MD, MPH

The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.

Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone

For patients with measurable disease at entry (at least one lesion that has a shortest diameter

≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that:

1. The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days.
2. The patient has died from any cause.
3. A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm.

Number of months from randomisation to the date of death from any cause

An individual visit response of PR was defined as a greater than or equal to 50% reduction in the sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions compared to baseline as long as the steroid dose has not been increased within the previous 10 days and no new lesions are present.

An individual visit response of CR was defined as the complete disappearance of all tumor on MRI scan.

Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.

The mean steroid dosage prior to treatment will be considered as the patient's baseline. The percent change in average daily steroid dosage from baseline is calculated by following formula: PC = (md - bm)/bm\*100; where PC is the percent change in average daily steroid dosage from baseline; md the mean daily steroid dosage recorded from the first day of therapy to progression; and bm the baseline mean.

Number of days known not to have used any steroids prior to progression

Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug.

Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64

Cediranib 30mg

Cediranib 20mg/Day + Lomustine 110mg/m2/Day

Cediranib 20mg + Lomustine 110mg

Lomustine 110mg/m2/Day + Placebo cediranib

Lomustine 110mg

Total

Age, Continuous

Gender

Gerard Lynch

Cediranib 20mg+ Lomustine 110mg

Progression Free Survival (PFS)

Overall Survival (OS)

Patients are only included in the analysis if they have measurable disease at baseline based on central.

Response Rate

Cediranib 20mg + Lomustine 100mg

Lomustine 100mg

Alive and Progression Free Rate at 6 Months (APF6)

Daily Steroid Dose

Cediranib 20mg + Lomustine 119mg

Steroid Free Days

Overall Study

Neoplasm Metastasis

Bevacizumab

Angiogenesis Inhibitors

Fosbretabulin

Combretastatin

Antineoplastic Agents, Immunological

Growth Inhibitors

Tubulin Modulators

Antimitotic Agents

Combretastatin A4 Phosphate (CA4P)

Bevacizumab (Avastin)

Paul Nathan, MD

Hillori Connors, MS

Peter Harris, MD

The purpose of this study is to determine the safety and tolerability of three dose levels of combretastatin A4 phosphate (CA4P) given intravenously (IV) in combination with bevacizumab every 14 days in patients with advanced solid tumors. The maximum tolerated dose will be defined if it is at one of the three dose levels under study.

Safety Study of Increasing Doses of Combretastatin in Combination With Bevacizumab (Avastin) in Patients With Advanced Solid Tumors

OXC4P1-105: A Phase I Study of the Safety, Tolerability, and Antitumor Activity of Escalating Doses of Combretastatin A4 Phosphate Given in Combination With Bevacizumab to Subjects With Advanced Solid Tumors

Mateon Therapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours	NCT00475956	Neoplasms	AZD2171 AZD0530	18 Years -	AstraZeneca
Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients	NCT05109650	Advanced Solid ...	BAT6026 BAT1308	18 Years -	Bio-Thera Solutions
Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients	NCT05109650	Advanced Solid ...	BAT6026 BAT1308	18 Years -	Bio-Thera Solutions
A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies	NCT00981721	Advanced Solid ...	cediranib (RECE...	18 Years -	AstraZeneca
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma	NCT00777153	Recurrent Gliob...	Cediranib Cediranib Lomustine Chemo... Placebo Cediran...	18 Years - 100 Years	AstraZeneca
Safety Study of Increasing Doses of Combretastatin in Combination With Bevacizumab (Avastin) in Patients With Advanced Solid Tumors	NCT00395434	Tumors	Combretastatin ... Bevacizumab (Av...	18 Years -	Mateon Therapeutics

Spots Global Cancer Trial Database for advanced solid tumour