Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily.

BBI503

This is an open label, multi-center, phase II study of BBI503 administered to adult patients with advanced gastrointestinal stromal tumor who have exhausted all currently approved standard anti-cancer treatment options. BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until patients are no longer clinically benefiting from therapy due to disease progression, adverse events, or another discontinuation criterion.

Safety, tolerability and efficacy of BBI503 will be assessed for the duration of study treatment.

A Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors

A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors

Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

Defined as the proportion of patients with a documented complete response and partial response (CR + PR) based on RECIST 1.1.

Defined as the time from enrollment to the first objective documentation of disease progression or death due to any cause.

Defined as the time from enrollment to death due to any cause.

All patients who have received at least one dose of BBI503 will be included in the safety analysis. The incidence of adverse events will be summarized by type of adverse event and severity.

Sumitomo Pharma America, Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

This is an open label, multi-center, Phase II study of BBI503 administered to adult patients with selected advanced urologic malignancies. The primary objective of this study is to evaluate the disease control rate of patients with renal cell cancer and urothelial carcinoma treated with BBI503.

A Study of BBI503 in Adult Patients With Advanced Urologic Malignancies

A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Urologic Malignancies

All patients who have received at least one dose of BBI608 will be included in the safety analysis. The incidence of adverse events will be summarized by type of adverse event and severity.

Gland and Hormone Related Diseases

Symptoms and General Pathology

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Recurrence

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

BBI503 will be administered orally, once daily. Dosing will begin at 200 mg once daily, preferably at bedtime and 2 hours after a meal. Dose modification in case of adverse events is allowed according to the schedule below; Full dose: 200 mg daily, Modification Level-1: 100 mg daily, Modification Level-2: 50 mg daily.

This was an open-label, single-arm, Phase II study in which amcasertib (BBI503) was administered to adult, asymptomatic patients with recurrent ovarian cancer who had elevated CA-125.

A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation

A Phase II Clinical Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation

Assessed by the Gynecologic Cancer Intergroup (GCIG) guidelines which incorporate both CA-125 response and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (the latter applies to patients who have measurable disease). DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).

The effect of amcasertib (BBI503) on PFS in asymptomatic recurrent ovarian cancer patients with CA-125 elevation

The effect of amcasertib (BBI503) on PFS at 6 months in asymptomatic recurrent ovarian cancer patients with CA-125 elevation

Assessed by the Gynecologic Cancer Intergroup (GCIG) guidelines which incorporate both CA-125 response and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (the latter applies to patients who have measurable disease).

Assessment of safety of amcasertib in participants by reporting of adverse events and serious adverse events

Participants who were enrolled into the study received amcasertib (BBI503), administered orally, once daily. Dosing began at 200 mg once daily, preferably at bedtime and 2 hours after a meal. Dose modification in case of adverse events was allowed according to following schedule: Full dose: 200 mg daily; Modification Level-1: 100 mg daily; Modification Level-2: 50 mg daily.

Arm A

Age, Continuous

Sex: Female, Male

Not Hispanic or Latino

Hispanic or Latino

Not Reported

Unknown

Missing

Race/Ethnicity, Customized

United States

Region of Enrollment

Tegan Nguyen

Due to a lack of efficacy in the solid tumor indications that were evaluated in early-stage trials of this compound, the entirety of the amcasertib development was discontinued by the sponsor. Analysis of the DCR was not performed since data were not collected.

Disease Control Rate (DCR)

Due to a lack of efficacy in the solid tumor indications that were evaluated in early-stage trials of this compound, the entirety of the amcasertib development was discontinued by the sponsor. Analysis of the PFS was not performed since data were not collected.

Progression Free Survival (PFS)

Due to a lack of efficacy in the solid tumor indications that were evaluated in early-stage trials of this compound, the entirety of the amcasertib development was discontinued by the sponsor. Analysis of the PFS-6 was not performed since data were not collected.

Progression Free Survival (PFS)-6

Due to a lack of efficacy in the solid tumor indications that were evaluated in early-stage trials of this compound, the entirety of the amcasertib development was discontinued by the sponsor. Analysis of the ORR was not performed since data were not collected.

Objective Response Rate (ORR)

Due to a lack of efficacy in the solid tumor indications that were evaluated in early-stage trials of this compound, the entirety of the amcasertib development was discontinued by the sponsor. Analysis of the OS at 6 months was not performed since data were not collected.

Overall Survival (OS) at 6 Months

Number of Patients With Adverse Events

Overall Study

Carcinoma, Hepatocellular

Liver Neoplasms

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Sorafenib 400mg twice daily (800mg total daily dose)

This is an open-label, multicenter, phase 1 dose escalation study of BBI503 monotherapy, or BBI503 in combination with Sorafenib. This study population is adult patients with advanced solid tumors in monotherapy, or adult patients with advanced hepatocellular carcinoma in combination therapy.

A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma

A Phase I Study of BBI503 Monotherapy in Patients With Advanced Solid Tumors, or BBI503 Plus Sorafenib Combination Therapy in Patients With Advanced Hepatocellular Carcinoma

The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

The time the participant stays on study until progression will be measured and recorded.

Participants follow-up for overall survival will occur. Maximum follow-up time is 1 year after the initial administration of the last subject.

Sumitomo Pharma Co., Ltd.

The BBI608 starting dose is 240 mg twice daily (480 mg total daily). Dose will be decreased to 160 mg twice daily (320 mg total daily) at modification level 2 and 80 mg twice daily (160 mg total daily) at modification level 3. For BBI608 once daily dosing, doses at starting level and modification level 1 are 240 mg once daily, and 480 mg once daily at escalated levels. Dose will be decreased to 160 mg once daily at modification level 2 and 80 mg once daily at modification level 3.

BBI608

The BBI503 starting dose is 200 mg once daily. Dose at modification level 1 to 3 will be 100 mg once daily.

This is an open label, multi-center, phase 1 study of BBI608 and BBI503 administered orally in combination to patients with advanced solid tumors. The primary goal is to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination regimen.

A Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors

A Phase Ib Clinical Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors

The overall tolerability assessment will include review of persistent grade 2 adverse events and review of adverse events occurring beyond the first cycle.

Tumor Biopsy to provide information on analysis of the effect of BBI608 and BBI503 on cancer stem cells through immunohistochemistry.

Dermatologic Agents

Anti-Infective Agents

Nivolumab

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Capecitabine

Doxorubicin

Liposomal doxorubicin

Sunitinib

Coal Tar

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antimetabolites

Angiogenesis Inhibitors

Growth Inhibitors

Patients in this trial will receive BBI503 orally, daily, and continuously. The dose-level of BBI503 will be assigned according to the dose-cohort open at the time the patient enrolls into a given arm. The study-arm and combination anti-cancer agent for a given patient will be determined by the investigator. BBI503 Dose Level 1: 200 mg once daily, Dose Level 2: 300 mg once daily.

Capecitabine 1000 mg/m\^2 body surface area is administered orally, twice daily, on days 1-14 of each 21 day cycle.

Doxorubicin 60 mg/m\^2 body surface area is administered intravenously once every three weeks (21-days).

Nivolumab 3 mg/kg is administered as an intravenous infusion over 60 minutes on day 1 and day 15 of each 28 day cycle.

Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes once every three weeks (21-days).

Paclitaxel 80 mg/m\^2 body surface area is administered intravenously once weekly on day 1, day 8, and day 15 of each 28 day cycle.

Sunitinib 37.5 mg is administered once daily.

This is an open label, multi-center, Phase 1/2 study of BBI503 administered in combination with selected anti-cancer therapeutics in adult patients with advanced cancer. The goal of the study is to determine the safety, tolerability, and RP2D of BBI503 in combination with each of the selected anti-cancer agents.

A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer

A Phase Ib/II Clinical Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer

Evaluation of anti-tumor activity will be performed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Histopathology and Cancer Stem Cell assays will be performed to provide information of the biomarkers on biopsied patient tumor tissue, and archival samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors	NCT02232620	Gastrointestina...	BBI503	18 Years -	Sumitomo Pharma America, Inc.
A Study of BBI503 in Adult Patients With Advanced Urologic Malignancies	NCT02232646	Urologic Malign... Renal Cell Carc... Urothelial Carc...	BBI503	18 Years -	Sumitomo Pharma America, Inc.
A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation	NCT02432690	Cancer Ovarian Cancer	BBI503	18 Years -	Sumitomo Pharma America, Inc.
A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma	NCT02354898	Advanced Solid ... Hepatocellular ...	BBI503 Sorafenib	20 Years -	Sumitomo Pharma Co., Ltd.
A Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors	NCT02432326	Cancer Advanced Solid ...	BBI608 BBI503	18 Years -	Sumitomo Pharma America, Inc.
A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer	NCT02483247	Cancer	BBI503 Capecitabine Doxorubicin Nivolumab Pembrolizumab Paclitaxel Sunitinib	18 Years -	Sumitomo Pharma America, Inc.

Spots Global Cancer Trial Database for bbi503

Every month we try and update this database with for bbi503 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 bbi503

Every month we try and update this database with for bbi503 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 bbi503 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.