Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Blood and Lymph Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Rare Diseases

Uterine Cervical Neoplasms

Recurrence

Breast Neoplasms

Head and Neck Neoplasms

Sarcoma

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Lymphadenopathy

Pelvic Neoplasms

Mouth Neoplasms

Anus Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Mouth Diseases

Stomatognathic Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Oral Cancer

Anal Cancer

Lip and Oral Cavity Cancer

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Dermatologic Agents

Liver Extracts

Talaporfin

Photosensitizing Agents

LS 11(Taporfin Sodium)

Lumaflex Light Delivery Catheter

Jay Winship, MD

This multi-center photodynamic therapy study plans to treat patients with large tumors in any superficial location, sarcoma, tumors of oral/oro-pharyngeal cavity, tumors with extensive pelvic involvement, or liver metastasis. The treatment is limited to patients that have failed to respond to currently approved methods of treatment. The study involves a single, intravenous administration of an investigational drug, LS11 (previously studied in approximately 80 cancer patients) and the placement of a novel, flexible light delivery catheter inside the tumor by a minor surgical procedure. The activation of LS11 by the light delivery catheter over a period of 1-24 hrs may result in destruction of tumor tissue.

In this Phase I photodynamic therapy study, patients will undergo a standard CT scan to determine the suitability of the treatment. In those patients that qualify the entry criteria, a light delivery catheter will be directly inserted in the tumor through a minor surgical procedure. The patients will then be injected with the photosensitive drug, LS11. One hour following the drug injection, light energy will be delivered from the light delivery catheter for a period of 1-24 hours. The duration of the light treatment for a given patient may be based on various factors including when a given patient enters the study. Following the delivery of light energy, the light delivery catheter will be removed from the tumor. The insertion and removal of the catheter will be carried out under the guidance of CT scan. The patients will be asked to take precautions from external light exposure for a period of time. The patients will undergo CT scan and other tests on days 7, 14 and 42 to evaluate safety of the treatment, tumor cell death and treatment response. Blood samples will be taken at different time points to examine the clearance of the drug from the body.

Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors

A Multicenter Phase I Safety and Tolerability Study of the Oncolux System for Intratumoral Delivery of Non-Coherent Light for the Photoactivation of LS 11 in Patients With Refractory Solid Tumors

Light Sciences LLC

Immunomodulating Agents

Camrelizumab: 200mg every 2 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.

Hypofractionated Radiotherapy(SABR): tumor center dose of 24-32Gy/8Gy/3-4f and surrounding important organs at risk ≤3.0Gy will be performed when one week following completion of the first immunotherapy. And the routine radiotherapy will be started with reaching a radical cure dose for the tumor margin. Generally, the radiotherapy will end before the fourth immunotherapy.

Immunotherapy combined with hyperfractionated radiotherapy

camrelizumab+hyperfractionated radiotherapy

Yun Bai, MD

Xianshu Gao, MD,PhD

This trial will explore effectiveness and safety using the combination therapy of camrelizumab and hyperfractionated radiotherapy in patients with massive tumor including non-small cell lung cancer, soft tissue sarcoma or urothelial carcinoma. Hypofractionation which represented by stereotactic body radiation therapy (SBRT) is a technique that delivers higher daily doses of radiation over a shorter period of time. This trial will also observe the index which can influencing the curative effect of hyperfractionated radiotherapy combined with immunotherapy.

This trial is a prospective, observational, single-center, single-arm clinical research. This trial will explore effectiveness and safety using the combination therapy of camrelizumab and hyperfractionated radiotherapy in patients with massive tumor including non-small cell lung cancer, soft tissue sarcoma or urothelial carcinoma. All enrolled patients will receive the following treatments: camrelizumab 200mg every 2 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. One week following completion of the first immunotherapy, hypofractionated radiotherapy(SABR) with tumor center dose of 24-32Gy/8Gy/3-4f and surrounding important organs at risk ≤3.0Gy will be performed. And the routine radiotherapy will be started with reaching a radical cure dose for the tumor margin. Generally, the radiotherapy will end before the fourth immunotherapy.

During treatment participants will be assessed for curative effects and the occurrence of adverse events. Following treatment, participants will be assessed at a clinic visit every 3 months to collect survival information and follow-up treatment information. The planned sample size is 60 study participants.

Combination of Hyperfractionated Radiotherapy With Immunotherapy in Massive Tumors

An Observational, Single-center Study of Radiotherapy Combined With Immunotherapy for Massive Tumors

The date of first treatment until the date of progression using the RECIST 1.1 criteria, or death due to any cause, whichever comes first.

Number of Adverse Events using NCI CTCAE 5.0

Overall survival, defined from the date of first treatment to the date of death due to any cause.

Objective response rate, which is defined as the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) using the RECIST 1.1 criteria.

Disease control rate, which is defined as the proportion of subjects who achieve a response of complete response，partial response and stable disease (PR+CR+SD) in the total number of evaluable subjects using the RECIST 1.1 criteria

Local Control Rate, which is defined as the proportion of subjects who achieve a response of remission and stable disease (PR+CR+SD) evaluated by RECIST 1.1 after radiotherapy

Distant metastasis-free survival(DMFS), defined from the date of first treatment to the date of the appearance of distant metastasis or death due to any cause.

Response rate of lesions that did not receive radiotherapy, which is defined as the percentage of the number of cases with tumors that have not received radiotherapy in remission and stable disease (PR+CR+SD) in the total number of evaluable cases using the RECIST 1.1 criteria.

Quality of life, which will be evaluated using the EORTC（The European Organization for Reasearch and Treatment of Cancer) QLQ-C30（Quality of Life Questionnare-Core 30） questionnaire. The questionnaire contains 30 items. Items 29 and 30 are divided into seven levels, which are counted from 1 to 7 points, 1 is very poor, and 7 is very good. Other items are divided into 4 levels: no at all, a little bit, a lot, and very, and they are directly rated from 1 to 4 points

Peking University First Hospital

Professor

Antibodies

Antibodies, Monoclonal

Immunoglobulins

For: Dose escalation phase/Phase II Expansion Phase. Cohorts of 3-6 patients were to be enrolled sequentially until an MTD or a recommended Phase II dose were defined. All patients were to receive the combination treatment. Sequential cohorts may receive different doses of the combination. In the Phase II expansion, all patients were to receive the same combination treatment.

BYL719 is a small molecule inhibiting PI3-Kinase.

BYL719

AMG 479 is a monoclonal antibody directed against IGF1-R.

AMG 479

Novartis Pharmaceuticals

This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. Patients were to be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. All patients were to be followed up. At a minimum, patients must have completed the safety follow-up assessments 30 days after the last dose of the study treatment.

This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study were to be guided by a Bayesian Logistic Regression Model (BLRM).

Once MTD/RP2D had been determined, patients were to be enrolled in two Phase II arms. Patients with PIK3CA mutated or amplified hormone receptor positive breast carcinoma were to be enrolled in Arm 1; patients with PIK3CA mutated or amplified ovarian carcinoma were to be enrolled in Arm 2. Patients were to be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. All patients were to be followed up. At a minimum, patients must have completed the safety follow-up assessments 30 days after the last dose of the study treatment.

A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

The antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer.

Overall response rate is defined as the proportion of patients who have a best overall response of complete response or partial response assessed per RECIST 1.1.

The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1

the antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer.

Phase II only, Cycle 1 Day 1 through Cycle 6 Day 28; assessed at baseline and every 8 weeks thereafter

Serum concentration for BYL719 (alpelisib)

1 cycle - 28 days of treatment

Area under curve for BYL719 (alpelisib)

1 cycle - 28 days of treatment

Tmax and half life of BYL719 (Alpelisib)

1 cycle - 28 days of treatment

Serum concentration for AMG 479 (ganitumab)

1 cycle - 28 days of treatment

Area under curve for AMG 479 (ganitumab)

1 cycle - 28 days of treatment

Tmax and half life of AMG 479 (ganitumab)

1 cycle - 28 days of treatment

NantCell, Inc.

One patients with a tumor type other than Breast and Ovarian treated in the phase II part not represented.

BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors

BYL 200mg + AMG 12 mg/kg

BYL 300mg + AMG 12 mg/kg

BYL 350mg + AMG 12 mg/kg

Patients with PIK3CA mutated or amplified hormone receptor (HR) positive breat carcinoma (BC) were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg

HR + BC - Phase II

Patients with other than Breast and Ovarian cancer treated in the phase II

Ovarian - Phase II

BYL 200mg + AMG 12mg/kg

BYL 300mg + AMG 12mg/kg

BYL 350mg + AMG 12mg/kg

Patients with PIK3CA mutated or amplified hormone receptor (HR) positive breast carcinoma (BC) were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg.

HR+BC - Phase II

Patients with PIK3CA mutated or amplified ovarian cancer were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg

Patients with other than Breast and Ovarian cancer treated in the phase II part

Non-HR+BC/Ovarian - Phase II

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Due to the competitive landscape for anticancer therapies in ovarian and breast cancer and given the limited clinical activity observed with the study combination treatment, Novartis decided in 2014 to halt the recruitment in the trial.

Study Director

Drug hypersensitivity

Hyperglycemia

Rash maculopapular

Urticaria

Dose determining set (DDS): DDS includes all patients from the safety set who either met the minimum treatment exposure and safety evaluation requirements without experiencing DLT within Cycle 1 or experienced a DLT at any time during Cycle 1.

Dose Limiting Toxicities (DLTs) - Phase Ib

The total column "All patients" includes a patient with non-HR+BC and non-Ovarian cancer treated in the Phase II part.

All Patients - Phase

Full analysis set (FAS). The full analysis set (FAS) includes all patients who received at least one full or partial dose of alpelisib or ganitumab. Patients were analyzed according to the planned treatment combination.

Percentage of Patients With Overall Response Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II

Complete response (CR)

Partial response (PR)

Stable disease (PD)

Progressive disease (PD)

Unknown

Number of Patients With Best Overall Response (RECIST) Based on Investigator Radiology Assessment - Phase Ib

Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment - Phase Ib

All Patients - Phase II

Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II

Cycle 1 Day 1

Cycle 1 day 15

Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors	NCT00028405	Liver Metastasi... Pelvic Cancer Head and Neck C... Sarcoma Rectal Cancer Breast Cancer Colorectal Canc... Mouth Cancer	LS 11(Taporfin ... Lumaflex Light ...	18 Years -	Light Sciences LLC
Combination of Hyperfractionated Radiotherapy With Immunotherapy in Massive Tumors	NCT04587817	Immunotherapy SBRT Bulky Tumor	camrelizumab+hy...	18 Years -	Peking University First Hospital
A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors	NCT01708161	PIK3CA Mutated ... PIK3CA Amplifie...	BYL719 AMG 479	18 Years -	Novartis
Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors	NCT00028405	Liver Metastasi... Pelvic Cancer Head and Neck C... Sarcoma Rectal Cancer Breast Cancer Colorectal Canc... Mouth Cancer	LS 11(Taporfin ... Lumaflex Light ...	18 Years -	Light Sciences LLC

Spots Global Cancer Trial Database for bulky tumor

Every month we try and update this database with for bulky tumor 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 bulky tumor

Every month we try and update this database with for bulky tumor 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 bulky tumor 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.