Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Adrenocortical Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

Mitogens

OSI-906

Placebo

Medical Director

A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens

Patients will be randomized 2:1 to receive either single agent OSI-906 (Arm A) or placebo (Arm B) and will be stratified according to prior systemic cytotoxic chemotherapy for ACC, and Eastern Cooperative Oncology Group (ECOG) performance status, and use of \>= 1 oral antihyperglycemic therapy at randomization

A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

Time from date of randomization until time of documented death

Time from randomization to disease progression based on RECIST version 1.1 or death due to any cause, whichever comes first

Proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), based on RECIST criteria

Proportion of patients with a best overall response of CR or PR based on RECIST criteria

Time from date of the first documented response (CP/PR) to documented progression or death due to underlying cancer

Measured by European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires

Astellas Pharma Inc

Thyroid Diseases

Anti-Inflammatory Agents

Vasoconstrictor Agents

Respiratory System Agents

Antineoplastic Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Epinephrine

Racepinephrine

Epinephryl borate

Mitotane

Antineoplastic Agents, Hormonal

Individuals in this group were under care by the Endocrinology Team with a diagnosis of an ACC and on mitotane. These individuals were further divided into 3 groups, depending on whether they had a mitotane plasma concentration, within (14-20mg/L), above or below the therapeutic concentration range.

Individuals within this category had an adrenal neoplasm and were not being treated with mitotane therapy.

Individuals did not have an adrenal neoplasm during this period, nor were they being treated with mitotane. These were healthy pregnant females, who were under the care at KCL during their pregnancy.

Individuals within the intervention group were on mitotane therapy as part of their ACC treatment.

This work will evaluate the effects of mitotane treatment on serum protein concentrations in patients treated for ACC with mitotane therapy and compare them to patients with an adrenal neoplasm and pregnant cohort. All of the individuals were treated at King's Hospital between April 2019 and June 2020. Proteins which will be evaluated during this study, include CBG and TBG.

Background: Adrenocortical Carcinoma (ACC) is a rare malignancy of the adrenal cortex. The annual incidence of ACC is thought to be between 0.5-2.0 cases per million. Adjunctive therapy with mitotane may be offered post- surgically to minimise risk of recurrence.

Aims: Evaluate the effects of mitotane treatment on serum protein concentrations in patients treated for ACC with mitotane therapy and compare to patients with an adrenal neoplasm and a pregnant cohort. Patients were treated at King's Hospital between April 2019 and June 2020.

Methods: Cortisol, TFT's ACTH, CBG, TBG and gonadotrophins will be measured during the same venepuncture using serum samples. SPSS v27 and GraphPad Prism v9.3.1 will be used for analysis and illustrations. Thirty-five patients will be included, within ACC with mitotane, adrenal neoplasm or pregnant groups. Data will be tested for normality, described as Mean± SD, compared using paired sample t-test with 5% p-value for significance and 95% confidence interval (CI).

The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma

The primary objective of this project is to determine the effects of mitotane therapy on serum thyroid binding and cortisol binding protein concentrations in patients with adrenocortical carcinoma and compare concentrations of the same binding proteins in patients with adrenal neoplasms not on treatment with mitotane and to a cohort of pregnant women.

King's College Hospital NHS Trust

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Triple Negative Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cholangiocarcinoma

Endometrial Neoplasms

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Carcinoma, Adenoid Cystic

Breast Diseases

Skin Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Bile Duct Cancer

Gallbladder Cancer

Fallopian Tube Cancer

Adenoid Cystic Carcinoma

SGN-B7H4V

Seagen Trial Information Support

Brandi Asheim

Jennifer Diamond

Jason Henry

Charmaine Garcia

Guru Sonpavde

Ivy Vilches

Gerardo Colon-Otero

Cesar Perez Batista, MD

Northwestern University CT.Gov Contact

Aparna Kalyan, MBBS

Adam Byers

Bert H O'Neil

Shannon Fabrie

Nehal Lakhani, MD, PhD

Melanie Hurst

Erika P Hamilton

Amanda Drews

Renata Ferrarotto

Isabel Jimenez

Amita Patnaik

Casey Larsen

Justin Call

Arif Awan

Antonia Busse

Giuseppe Curigliano

Elena Garralda Cabanas

Irene Moreno Candilejo

Elisa Fontana

Medical Monitor

This study will test the safety of a drug called SGN-B7H4V in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-B7H4V is and if it works to treat solid tumor cancers.

A Study of SGN-B7H4V in Advanced Solid Tumors

A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by investigator.

The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.

The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause.

The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.

The time from the start of any study treatment to the date of death due to any cause.

To be summarized using descriptive statistics.

Seagen Inc.

Anti-Infective Agents

Etoposide

Doxorubicin

Liposomal doxorubicin

Vincristine

Etoposide phosphate

polysaccharide-K

Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.

Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m\^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m\^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m\^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3.

XR9576 (Tariquidar)

Antonio Fojo, M.D.

This study will examine the safety and effectiveness of treating adrenocortical cancer with combination chemotherapy using doxorubicin, vincristine, and etoposide in addition to the drugs mitotane and tariquidar and, when possible, surgery. Adrenocortical cancer cells have a large amount of a protein called P-glycoprotein that "pumps" anti-cancer drugs out of the cells, decreasing their effectiveness. Continuous infusions of doxorubicin, vincristine, and etoposide may improve chemotherapy results by blocking the P-glycoprotein pump, as may use of tariquidar, an experimental drug that is known to block the P-glycoprotein pump.

Patients 18 years of age and older with adrenocortical cancer that has recurred, spread, or cannot be treated surgically may be eligible for this study. Candidates will be screened with a medical history and physical examination; review of pathology slides; blood tests; electrocardiogram (EKG); imaging tests, including computed tomography (CT) of the chest, abdomen and pelvis; chest x-ray; and possibly a bone scan or other imaging tests needed to evaluate the cancer, urine studies, and an echocardiogram. Also, a biopsy (removal of a small sample of tumor tissue) may be required if a specimen is not available to confirm the cancer.

Participants will undergo the following tests and procedures:

* Tumor biopsy. Before starting chemotherapy, a small piece of tumor is removed to study the P-glycoprotein pump and to determine the tumor genetics.
* Blood draw. Blood is drawn before treatment begins to establish baseline levels for future blood tests.
* Central venous catheter placement. A specially trained physician places a plastic tube into a major vein in the chest. The tube is used to give the study drugs and other medications and to withdraw blood samples. It can stay in the body for months or be removed after each treatment is completed. The tube placement is done under a local anesthetic in the radiology department or operating room.
* Chemotherapy. Treatment cycles are 21 days. Doxorubicin, vincristine, and etoposide are given through the central venous catheter by an infusion pump continuously over 96 hours starting day 1 of each cycle. The dose of these drugs may be increased or decreased from cycle to cycle, based on side effects. Mitotane is given in pill form starting day 1 of cycle 1 and is taken every day throughout the entire study. The mitotane dose is gradually increased as long as the side effects are tolerable. Tariquidar is given through the central venous catheter as a 30-minute infusion on days 1 and 3 of every cycle. The tariquidar dose remains the same throughout the study. Treatment will continue for two cycles after all the cancer is gone, or until surgery is done to remove some or all of the remaining cancer, or, if surgery is not an option, until the cancer has grown to where it is defined as progressive disease.
* Nuclear scans. A nuclear scan is done before treatment begins and again on day 1 or day 3 of the first treatment cycle after administration of tariquidar to evaluate the P glycoprotein response to treatment.
* Computed tomography (CT) scans. These scans are done every two treatment cycles to follow disease progress.
* Surgery. Surgery to remove areas of cancer may be considered at any point during the study (including before beginning treatment), if it is deemed beneficial. Treatment with the study drugs will begin or resume after surgery. The length of treatment will depend on the response to treatment before the surgery and on whether there is any cancer remaining after the surgery.

Adrenocortical cancer (ACC) is a rare tumor that is optimally treated with surgical resection. However, many patients present with unresectable disease and relapses are common after surgical resection creating a need for more effective systemic therapies. Several investigators have reported responses to a variety of chemotherapy agents, without a clear improvement in overall survival. A possible explanation for these disappointing results is the high levels of expression of P-glycoprotein (Pgp) seen in a majority of adrenocortical cancers. Pgp, a membrane protein that can function as a drug efflux pump lowering the intracellular concentrations of various drugs, has been implicated as a mechanism of drug resistance.

A prior National Cancer Institute (NCI) study (referred to as MAVE) tried to improve response rates by using a combined modality approach with chemotherapy and surgery. Prior in vitro studies had shown that mitotane inhibited Pgp and that continuous exposure to doxorubicin and vincristine was more effective at overcoming Pgp-mediated resistance than the same drugs given on an intermittent schedule. The MAVE study used daily oral mitotane with infusional doxorubicin, vincristine, and etoposide prior to tumor resection in patients with resectable or potentially resectable tumors. The results showed an overall response rate of 19% (including minor responses), and an overall median survival of 13.5 months. These results were similar to those reported with previous regimens in adrenocortical cancer (ACC). A possible explanation for the failure to achieve a higher response rate may be that mitotane was unable to inhibit Pgp. Although the serum levels of mitotane achieved in patients had been shown to block Pgp in vitro, inhibition of Pgp in patients was not accomplished, as documented by a validated surrogate assay using Pgp-expressing CD56+ cells and the Pgp substrate, rhodamine. Thus the question of whether Pgp inhibition would improve response rates remains unanswered.

This trial will attempt to answer the latter question by using an agent, tariquidar (XR9576), which has been proven to inhibit Pgp in humans with minimal toxicity alone or in combination with chemotherapy. Tariquidar will be used with the regimen from the prior MAVE study in an effort to improve response rates and overall survival in patients with ACC whose options at this time are limited.

Surgery Plus Chemotherapy (Doxorubicin, Vincristine and Etoposide), Mitotane, and Tariquidar to Treat Adrenocortical Cancer

A Study of Combination Chemotherapy & Surgical Resection in the Tx of Adrenocortical Cancer: Mitotane & Continuous Infusion Doxorubicin, Vincristine & Etoposide w/the P-glycoprotein Antagonist, Tariquidar (XR9576), Before & After Surgical Resection

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all signs and symptoms of tumor for a period of at least 4 weeks. Partial response is defined as at least a 30% decrease in the sum of the longest diameter of all measured lesions lasting for a period of 4 weeks.

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

National Cancer Institute (NCI)

Antonio Fojo, M.D./National Cancer Institute

Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.

Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m\^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m\^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3.

Surgery Plus Chemothrapy

Age, Categorical

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Complete Response

Partial Response

Surgery Plus Chemotherapy

Percentage of Participants With a Partial or Complete Response

Number of Participants With Adverse Events

Overall Study

Mouth and Tooth Diseases

Salivary Gland Neoplasms

25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost

Carbon ion irradiation

25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost

Bimodal irradiation

Klaus Herfarth, Prof. Dr.

Adenoid cystic tumors are rare tumors of the head and neck region. Despite their slow growth, re-irradiation is often necessary due to the high metastatic risk. Patients are usually irradiated with photons or, as here at the Heidelberg University Hospital, with a combination of carbon ions and photons. So far, there is no data from Europe available for the sole irradiation with carbon ions. The present ACCO (Adenoid Cystic Carcinoma and Carbon ion Only irradiation) study, a prospective, open-label, phase II, single-arm, investigator-initiated study, will therefore investigate the sole radiotherapy of carbon ions in this tumor entity. Irradiation is applied - significantly shorter than the combination therapy - in about 4 weeks (22 fractions); patients are followed up for further 5 years after the start of therapy. Carbon ions alone are expected to increase local tumor control rates from 60% to 70% after 5 years (primary objective criterion of this study). In order to reject the null hypothesis with a power of 80% and a significance level of 5%, 175 patients are included (including a drop-out rate of 15%). Secondary objective criteria are progression-free survival, overall survival, acute and late toxicity, and quality of life.

Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Freedom from loco-regional tumor progression according to MR imaging

Acute toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity \> 2 grade)

Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity \> 2 grade)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma	NCT00924989	Adrenocortical ...	OSI-906 Placebo	18 Years -	Astellas Pharma Inc
The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma	NCT05344027	Adrenocortical ...	Mitotane	19 Years - 85 Years	King's College Hospital NHS Trust
A Study of SGN-B7H4V in Advanced Solid Tumors	NCT05194072	Ovarian Neoplas... Peritoneal Neop... Fallopian Tube ... Triple Negative... HER2 Negative B... Hormone Recepto... Endometrial Neo... Carcinoma, Non-... Cholangiocarcin... Gallbladder Car... Adenoid Cystic ...	SGN-B7H4V	18 Years -	Seagen Inc.
Surgery Plus Chemotherapy (Doxorubicin, Vincristine and Etoposide), Mitotane, and Tariquidar to Treat Adrenocortical Cancer	NCT00071058	Adrenal Cortex ...	XR9576 (Tariqui...	18 Years -	National Institutes of Health Clinical Center (CC)
Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation	NCT04214366	Adenoid Cystic ...	Carbon ion irra... Bimodal irradia...	18 Years - 80 Years	Heidelberg University
A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma	NCT00924989	Adrenocortical ...	OSI-906 Placebo	18 Years -	Astellas Pharma Inc
CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC	NCT05774899	Adenoid Cystic ... Metastatic Aden... Recurrent Adeno...	CB-103 Abemaciclib Lenvatinib	18 Years -	Dana-Farber Cancer Institute
Surgery Plus Chemotherapy (Doxorubicin, Vincristine and Etoposide), Mitotane, and Tariquidar to Treat Adrenocortical Cancer	NCT00071058	Adrenal Cortex ...	XR9576 (Tariqui...	18 Years -	National Institutes of Health Clinical Center (CC)
A Phase II Study of Dovitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands	NCT01678105	Recurrent Adeno... Metastatic Aden... Salivary Gland ... ACC	Dovitinib	18 Years -	Ontario Clinical Oncology Group (OCOG)
Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma	NCT01898715	Adrenocortical ... Adrenal Cancer ACC	ATR-101	18 Years -	Millendo Therapeutics, Inc.
A Study of SGN-B7H4V in Advanced Solid Tumors	NCT05194072	Ovarian Neoplas... Peritoneal Neop... Fallopian Tube ... Triple Negative... HER2 Negative B... Hormone Recepto... Endometrial Neo... Carcinoma, Non-... Cholangiocarcin... Gallbladder Car... Adenoid Cystic ...	SGN-B7H4V	18 Years -	Seagen Inc.

Spots Global Cancer Trial Database for acc

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

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