Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

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

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Molgramostim

Sargramostim

Vaccines

Albumin-Bound Paclitaxel

Immunologic Factors

Tubulin Modulators

Antimitotic Agents

AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total)

Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)

\* Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles

Placebo with rhuGM-CSF (3-week interval, 3 cycles in total)

Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)

\*Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles

i.d. (3-week interval, 3 cycles in total)

AST-201

Placebo

rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)

Hyunwon Shin, MD, PhD

Eunkyo Joung, MD, CMO

John B. Liao, MD, PhD

The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel/Carboplatin).

The study will comprise a screening period of -28 Days prior to initiation of study treatment (Day 1); an enrollment period of 24 months; the treatment duration will be approximately of 5 months.

The study will evaluate whether the addition of AST-201/rhuGM-CSF to the standard adjuvant chemotherapy will extend the Progression Free Survival(PFS) rate. Survival follow-up will be performed every 3 months (±14 days) after the End of treatment (EOT) visit for 2 years after randomization and every 6 months (±28 days) thereafter until disease progression or death from any cause or withdrawal of consent whichever comes first. Survival follow-up visits will be conducted by telephone, in-person visit, or chart review. The end of study (EOS) is defined as 2 years after the date of last patient enrollment.

Single blind, randomized, placebo-controlled, multicenter, phase 2 clinical study

Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer

A Randomized Phase 2 Study to Evaluate the Efficacy and Safety for Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone-004)

the time from the date of randomization to disease progression, or death from any cause whichever occurs first

proportion of patients alive without disease progression or death at two years after the randomization

the time from the date of randomization to death from any cause

Adverse events (AEs) Treatment-emergent adverse events (TEAEs) Serious adverse events (SAEs) Vital signs Physical examination Eastern Cooperative Oncology Group (ECOG) performance status Electrocardiogram (ECG) test Laboratory tests

Aston Sci. Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Fluorouracil

Participants received 400 milligrams (mg) of TAS-114 tablets orally twice daily (BID) along with 30 milligrams per meter square (mg/m\^2) of S-1 capsule BID for 2 weeks (Day 1 to 14), followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 51 weeks).

Participants received 30 mg/m\^2 of S-1 capsules BID for 2 weeks (Day 1 to 14) followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 38 weeks).

TAS-114 was a modulator of 5-fluorouracil (5-FU).

TAS-114

S-1 was designed to provide oral delivery of 5-FU and to reduce the rate of degradation of 5-FU in vivo.

Taiho Central

This is a randomized, open-label, Phase 2 study of TAS-114 administered in combination with S-1, to investigate the efficacy, safety and tolerability of the TAS-114/S-1 regimen in patients with advanced or metastatic NSCLC.

The study will be conducted internationally in 2 regions: Asian \[Japan\] and Western \[Europe and US\]. Patients will be randomized into TAS-114/S-1 arm versus S-1 control arm in a 1:1 ratio.

Randomization will take place once the consented patient has completed all the necessary baseline procedures and is deemed eligible for study entry. Treatment assignment will be done centrally using a dynamic allocation method (biased coin) via an interactive voice/web response system (IXRS) stratified by:

* Geographical region (Region 1: Asian \[Japan\]; Region 2: Western \[Europe and US\])
* Histological subtypes (nonsquamous cell carcinoma \[including mixed\] and squamous cell carcinoma)

A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1

A Randomized, Open-Label, Multi-Center, International Phase 2 Study of TAS-114 in Combination With S-1 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Progression-free survival was defined as the time (in months) from the day of randomization to the start of radiologic disease progression or death (any cause), whichever occurred first. Response assessments were made based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). As per RECIST 1.1 criteria, progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). (Note: the appearance of one or more new lesions was also considered progressions). Participants who did not have disease progression or died were censored at the last known time that the participant was progression free.

OS was defined as the time from the first dose of the study treatment to death from any cause. Participants who were alive at the end of study were censored at the last date the participant was known to be alive. OS was estimated from Kaplan-Meier method.

ORR was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and non-target lesions and normalization of tumor marker level. Any pathological and non-pathological lymph nodes must have reduction in short axis to less than (\<) 10 mm. PR was defined as at least a 30 percent (%) decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters.

DCR was defined as the percentage of participants with objective evidence CR, PR, or stable disease (SD). Based on the central review of tumor assessments per RECIST, version 1.1. CR was defined as disappearance of all target lesions. Reduction in any pathological lymph nodes in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameters during study.

DR was derived for participants with objective evidence of PR or CR. DR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause. Participants who were alive and progression-free as of the analysis cut-off date were censored at their last evaluable tumor response assessment before initiation of any new anticancer treatment.

An adverse event (AE) was defined as any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study treatment. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened during the TEAE period which was defined as the period from the time of first dose of study treatment until 30 days after last dose of study treatment. AEs included both serious and non- serious adverse events.

Taiho Oncology, Inc.

Analysis was performed on As-Treated (AT) population which included all participants who received at least 1 dose of TAS-114 or S-1.

Participants received 400 mg of TAS-114 tablets orally BID along with 30 mg/m\^2 of S-1 capsule BID for 2 weeks (Day 1 to 14), followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 51 weeks).

TAS-114 + S-1

S-1 (Monotherapy)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Baseline population included all participants randomized in the study, regardless of whether they actually received any study treatment (TAS-114 or S-1) or not.

Intent-to-Treat (ITT) population included all participants randomized in the study, regardless of whether they actually received any study treatment (TAS-114 or S-1) or not.

Progression-free Survival (PFS) Based on Central Independent Review

Overall Survival (OS)

Tumor response (TR) population included all participants randomized in the study, regardless of whether they actually received any study treatment (TAS-114 or S-1) or not; with measurable disease (at least one target lesion) at baseline and with at least one tumor evaluation (participants who had disease progression or had a cancer related death prior to their 1st tumor evaluation were also considered evaluable).

Overall Response Rate (ORR) Based on Central Independent Review

Disease Control Rate (DCR) Based on Central Independent Review

Duration of Response (DR) Based on Central Independent Review

Participants with TEAEs

Participants with TESAEs

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Overall Study

Symptoms and General Pathology

Mouth and Tooth Diseases

Recurrence

Neoplasm Metastasis

Carcinoma, Adenoid Cystic

Salivary Gland Neoplasms

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Adenocarcinoma

Adenoid Cystic Carcinoma

Oral Cancer

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients with progressive, recurrent and/or metastatic ACC treated with sunitinib 37.5 mg daily in this single-arm, two-stage phase II trial.

37.5 mg taken orally, daily every 28-day cycles

Sebastien Hotte, MD

This is a phase II study to evaluate the effectiveness of study drug sunitinib malate in patients with recurrent and/or metastatic adenoid cystic carcinomas of the salivary gland. There currently is not standard of care for this type of cancer and it has hoped that sunitinib will have antitumor effects on patients with this type of cancer.

This is an open-label phase II study of sunitinib malate in patients with recurrent and/or metastatic adenoid cystic carcinomas (ACC) of major or minor salivary gland origin. Sunitinib is a novel, multi-targeted small molecule inhibitor of the receptor tyrosine kinases (RTKs), including vascular endothelial growth factor receptors (VEGFs), platelet derived growth factor receptors (PDGFRs) and stem cell factor receptor (KIT), that are involved in tumour proliferation and angiogenesis. VEGF expression has been associated clinically with disease prognosis in many different types of cancers and a number of studies have suggested that VEGF may play an important role in the pathogenicity of ACC. Sunitinib is expected to inhibit PDGF- and VEGF-driven angiogenesis and, as a consequence, limit solid tumour growth.This study will determine the anti-tumour activity of sunitinib in ACC of the salivary glands using objective response rates (partial and complete responses) as its primary objective.

A Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands

A Phase 2 Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands

University Health Network, Toronto

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.

Patrick Forde, MB, BCH

The purpose of this study is to determine whether Nivolumab is effective in the treatment of radiation-induced solid tumors.

Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure

Number of participants with response. Response will be assessed at baseline (within 4 weeks prior to starting nivolumab) and then every 8 weeks while on Nivolumab, up to 24 weeks. The best objective response will be assessed at 24 weeks. Response will be defined based on RECIST 1.1 criteria where complete response (CR)= disappearance of all target lesions, partial response (PR) is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Disease status at 24 weeks will be compared to disease status at the time of enrollment, and response coded based on RECIST 1.1 criteria.

Number of participants alive without progression.

The duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, accessed up to 3 years.

Number of participants with treatment-related adverse events as defined by CTCAE 4.0 criteria.

Overall survival was planned to be measured at 5 years post-intervention as the time from enrollment until death. Instead, due to early termination for low accrual, the number of participants alive at the time of study termination is reported.

Bristol-Myers Squibb

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.

Nivolumab

Radiation-Induced Metastatic Sarcoma

Radiation-Induced Non-Sarcoma Metastatic Solid Tumors

Age, Categorical

United States

Region of Enrollment

Patrick Forde, MBBCh

Data was not collected for 1/2 participants from the non-sarcoma arm since the participant was discontinued from therapy (due to adverse event) before disease re-evaluation for response could be performed.

Best Objective Response Rate

Data was not collected to assess this outcome measure since no participants remained on the study at 24 weeks.

Percentage of Patients Progression-free at 24 Weeks From the Time of Enrollment

Progression-free Survival

Data was not collected to assess this outcome measure since none of the participants experienced a response.

Duration of Response

Number of Participants With Treatment-related Adverse Events

Overall Survival

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Disease Attributes

Epithelial-myoepithelial Carcinoma

CYH33

Xiaohua Wu, MD

Xiaohua wu, Director

Kan Yonemori, MD

The purpose of this study is to determine the treatment efficacy of CYH33 monotherapy in patients with recurrent or persistent ovarian, fallopian tube or primary peritoneal clear cell carcinoma harboring PIK3CA hotspot mutation, who received prior systemic anti-tumor treatment.

The purpose of this study is to determine whether treatment with single agent CYH33 significantly improves ORR compared to historical efficacy data in patients with recurrent/persistent ovarian clear cell carcinoma (OCCC) harboring PIK3CA hotspot mutations who received prior systemic anti-tumor treatment.

A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma

A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of CYH33, a Selective PI3Kα Inhibitor in Patients With Recurrent/Persistent Ovary, Fallopian Tube or Primary Peritoneal Clear Cell Carcinoma

type, incidence, duration, severity and seriousness of adverse events (AEs)

Number and proportion of patients who experienced DLT during the first 28-day of treatment in Japanese patients in safety run-in study.

Tumor ORR per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in patients with PIK3CA hotspot mutations.

OS in each of the PIK3CA mutation status cohort

genetic and protein biomarker alterations that can impact PI3K signaling pathway

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer	NCT05794659	Advanced Ovaria...	AST-201 Paclitaxel Carboplatin Placebo rhuGM-CSF(Granu...	18 Years -	Aston Sci. Inc.
A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1	NCT02855125	Advanced or Met...	TAS-114 S-1	18 Years -	Taiho Oncology, Inc.
A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1	NCT02855125	Advanced or Met...	TAS-114 S-1	18 Years -	Taiho Oncology, Inc.
A Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands	NCT00886132	Adenoid Cystic ... Salivary Gland ...	Sunitinib	18 Years -	University Health Network, Toronto
Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure	NCT02864316	Solid Tumors In...	Nivolumab	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma	NCT05043922	Ovarian Cancer Recurrent Cance...	CYH33	18 Years -	Haihe Biopharma Co., Ltd.
Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer	NCT05794659	Advanced Ovaria...	AST-201 Paclitaxel Carboplatin Placebo rhuGM-CSF(Granu...	18 Years -	Aston Sci. Inc.
A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma	NCT05043922	Ovarian Cancer Recurrent Cance...	CYH33	18 Years -	Haihe Biopharma Co., Ltd.
A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma	NCT05043922	Ovarian Cancer Recurrent Cance...	CYH33	18 Years -	Haihe Biopharma Co., Ltd.
Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure	NCT02864316	Solid Tumors In...	Nivolumab	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for phase 2 study