CLINICAL TRIALS PROFILE FOR PARAPLATIN

505(b)(2) Clinical Trials for Paraplatin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00186888 ↗	Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2005-04-07	Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the light sensitive layer of tissue that lines the back of the eyeball; sends visual messages through the optic nerve to the brain. When only one eye is affected, this is known as unilateral retinoblastoma and when both eyes are affected, it is called bilateral retinoblastoma. Treatment for retinoblastoma is individualized for each patient and is based on the form and the stage of the disease (inside the eye or has moved outside). The main goal is always to cure the cancer, and save the life of the child. Treatments are also designed with the hope of saving the vision, while completely destroying the tumor. Therapies may involve surgery, chemotherapy, radiation, and other treatments called focal treatments. Focal treatments may be laser therapy, freezing, or heat treatments meant to shrink and kill the tumor. In this study, researchers want to investigate how different participants respond to different therapies that are individualized specifically for them. Participants will be divided into three main groups, depending on whether the disease is unilateral or bilateral, and the stage of the disease. One of the main objectives of the study is to investigate how advanced tumors in children with bilateral disease respond to a new combination of chemotherapy with topotecan and vincristine, with G-CSF support. In order to improve results, some children with very advanced disease may receive carboplatin chemotherapy given around the eye at the same time that they receive topotecan by vein. Also, because children with retinoblastoma are diagnosed so early in life and the vision may be significantly impaired, this study will investigate how children develop and how the brain adjusts and compensates for the visual deficits. Finally, this study also investigates the biology of retinoblastoma, in order to understand better how this cancer develops.
New Combination	NCT00186888 ↗	Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma	Active, not recruiting	St. Jude Children's Research Hospital	Phase 3	2005-04-07	Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the light sensitive layer of tissue that lines the back of the eyeball; sends visual messages through the optic nerve to the brain. When only one eye is affected, this is known as unilateral retinoblastoma and when both eyes are affected, it is called bilateral retinoblastoma. Treatment for retinoblastoma is individualized for each patient and is based on the form and the stage of the disease (inside the eye or has moved outside). The main goal is always to cure the cancer, and save the life of the child. Treatments are also designed with the hope of saving the vision, while completely destroying the tumor. Therapies may involve surgery, chemotherapy, radiation, and other treatments called focal treatments. Focal treatments may be laser therapy, freezing, or heat treatments meant to shrink and kill the tumor. In this study, researchers want to investigate how different participants respond to different therapies that are individualized specifically for them. Participants will be divided into three main groups, depending on whether the disease is unilateral or bilateral, and the stage of the disease. One of the main objectives of the study is to investigate how advanced tumors in children with bilateral disease respond to a new combination of chemotherapy with topotecan and vincristine, with G-CSF support. In order to improve results, some children with very advanced disease may receive carboplatin chemotherapy given around the eye at the same time that they receive topotecan by vein. Also, because children with retinoblastoma are diagnosed so early in life and the vision may be significantly impaired, this study will investigate how children develop and how the brain adjusts and compensates for the visual deficits. Finally, this study also investigates the biology of retinoblastoma, in order to understand better how this cancer develops.
New Combination	NCT05156970 ↗	Camrelizumab in Combination With Chemotherapy or Apatinib Mesylate as First-Line Treatment for R/M HNSCC	Recruiting	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Phase 2	2021-06-24	This study is the first clinical study of first-line treatment of head and neck squamous cell carcinoma with drugs targeting VEGF signaling pathway combined with PD-1 inhibitors in China, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.

All Clinical Trials for Paraplatin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002852 ↗	Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1996-10-01	Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.
NCT00002944 ↗	Combination Chemotherapy in Treating Children With Progressive Brain Tumors	Completed	National Cancer Institute (NCI)	Phase 3	1997-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.
NCT00002944 ↗	Combination Chemotherapy in Treating Children With Progressive Brain Tumors	Completed	Children's Oncology Group	Phase 3	1997-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.

Clinical Trial Conditions for Paraplatin

Condition Name

Condition Name for Paraplatin
Intervention	Trials
Lung Cancer	36
Non-Small Cell Lung Cancer	31
Ovarian Cancer	30

Condition MeSH

Condition MeSH for Paraplatin
Intervention	Trials
Lung Neoplasms	171
Carcinoma	153
Carcinoma, Non-Small-Cell Lung	149

Clinical Trial Locations for Paraplatin

Trials by Country

Trials by Country for Paraplatin
Location	Trials
Australia	93
Japan	91
Spain	66
Argentina	9
Taiwan	9

Trials by US State

Trials by US State for Paraplatin
Location	Trials
Texas	206
California	199
Ohio	187
New York	171
Pennsylvania	168

Clinical Trial Progress for Paraplatin

Clinical Trial Phase

Clinical Trial Phase for Paraplatin
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	87
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for Paraplatin
Clinical Trial Phase	Trials
Completed	242
Recruiting	131
Active, not recruiting	104

Clinical Trial Sponsors for Paraplatin

Sponsor Name

Sponsor Name for Paraplatin
Sponsor	Trials
National Cancer Institute (NCI)	295
M.D. Anderson Cancer Center	62
Genentech, Inc.	31

Sponsor Type

Sponsor Type for Paraplatin
Sponsor	Trials
Other	627
Industry	308
NIH	300

Paraplatin (Carboplatin): Clinical Trials, Market Analysis, and Projections

Introduction to Paraplatin (Carboplatin)

Paraplatin, commonly known as carboplatin, is a chemotherapy drug used to treat various types of cancer, including ovarian, lung, head and neck, and testicular cancers. It belongs to the platinum-based class of drugs and works by interfering with the DNA of cancer cells, preventing them from reproducing.

Clinical Trials Update

Efficacy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

A recent phase IV clinical trial, KEYNOTE-B10, evaluated the efficacy and safety of pembrolizumab plus carboplatin and paclitaxel as a first-line treatment for R/M HNSCC. The study showed promising antitumor activity and a manageable safety profile. Out of 101 treated patients, 49% achieved an objective response, including 7% with a confirmed complete response. This combination is being considered as an alternative to the standard treatment of pembrolizumab plus platinum and fluorouracil, which is associated with several challenges such as continuous infusion, high administration costs, and significant toxicities[1].

Comparison with Other Chemotherapy Regimens

In another clinical trial, the efficacy and toxicity of paclitaxel and carboplatin (PC) were compared to bleomycin, etoposide, and cisplatin (BEP) for the treatment of newly diagnosed ovarian sex cord-stromal tumors (SCST). Although the trial was stopped early due to futility of the PC arm, it indicated that both regimens could be considered for patients with advanced or recurrent SCST, with PC showing fewer grade 3 or higher adverse events[4].

Market Analysis

Global Market Overview

The global carboplatin market is expected to witness robust expansion in the coming years. Market research reports indicate that the carboplatin market will register a significant Compound Annual Growth Rate (CAGR) in terms of revenue, with the global market size projected to reach a substantial figure by 2025[5].

Market Segmentation

The carboplatin market is segmented by types, including carboplatin crystal and carboplatin powder. In terms of applications, the market covers carboplatin injections and other uses. Geographically, the market is analyzed across key regions such as the USA, Europe, China, Japan, India, and South East Asia[2][5].

Key Drivers and Challenges

The growth of the carboplatin market is driven by several factors, including an increasing geriatric population, high acceptance of novel therapies, and government initiatives to propel research and development. However, the market also faces challenges such as the impact of the COVID-19 pandemic on the supply chain and market size growth rate. Companies in the carboplatin API market are undertaking various strategies to mitigate these challenges, including supply chain analysis and impact assessments[5].

Competitive Landscape

The global carboplatin market is competitive, with several key players such as Teva, Fresenius Kabi, Mylan, Qilu, and Taj Pharmaceuticals. These companies are engaged in various competitive developments, including expansions, agreements, new product launches, and acquisitions. The market research reports provide a comprehensive analysis of the growth strategies of these key players[2][5].

Market Projections

Revenue Growth

The carboplatin API market is expected to register a significant CAGR in terms of revenue over the next five years. The global market size is projected to reach a substantial figure by 2025, up from its value in 2019. This growth is attributed to the increasing demand for carboplatin in cancer treatment and the expanding product pipeline[5].

Regional Growth

Regionally, North America, particularly the USA, holds a significant share in the global carboplatin market due to the presence of a large number of clinical trials and high acceptance of novel therapies. China is also expected to emerge as a prominent market in the forthcoming years due to the presence of several domestic carboplatin manufacturers and a large population prone to cancer[3][5].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the carboplatin API market, affecting the supply chain and market size growth rate. Market research reports have analyzed the impact of the pandemic under various scenarios and outlined measures that companies can take to respond to these challenges. Despite these challenges, the market is expected to recover and continue its growth trajectory[5].

Key Takeaways

• Clinical Efficacy: Carboplatin, when combined with other drugs like pembrolizumab and paclitaxel, shows promising antitumor activity and a manageable safety profile in various cancers.
• Market Growth: The global carboplatin market is expected to grow significantly, driven by increasing demand and government initiatives.
• Regional Expansion: North America and China are key regions driving the market growth.
• Competitive Landscape: The market is competitive with several key players focusing on expansions, new product launches, and acquisitions.
• COVID-19 Impact: The pandemic has affected the supply chain, but the market is expected to recover and continue growing.

FAQs

What is the current status of carboplatin in clinical trials for R/M HNSCC?

Carboplatin, when combined with pembrolizumab and paclitaxel, has shown promising antitumor activity and a manageable safety profile in first-line treatment for R/M HNSCC in the KEYNOTE-B10 trial[1].

How does the carboplatin market segment by types and applications?

The carboplatin market is segmented by types (carboplatin crystal and carboplatin powder) and applications (carboplatin injections and other uses)[2][5].

What are the key drivers of the global carboplatin market?

The key drivers include an increasing geriatric population, high acceptance of novel therapies, and government initiatives to propel research and development[5].

How has the COVID-19 pandemic affected the carboplatin API market?

The pandemic has affected the supply chain and market size growth rate, but companies are taking measures to mitigate these challenges, and the market is expected to recover[5].

Which regions are expected to drive the growth of the carboplatin market?

North America, particularly the USA, and China are expected to be key regions driving the market growth due to various factors including clinical trials and domestic manufacturing[3][5].

Sources

1. Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: Results of the KEYNOTE-B10 Study. PubMed.
2. Carboplatin Market Projections, SWOT Analysis, Risk Analysis And Forecast By 2025. PharmiWeb.
3. Global PARP Inhibitors Drug Therapy Market Forecast 2028. BioSpace.
4. Results of a Randomized Phase II Trial of Paclitaxel and Carboplatin Compared to Bleomycin, Etoposide, and Cisplatin for Treatment of Newly Diagnosed Ovarian Sex Cord-Stromal Tumors. PubMed.
5. Carboplatin API Market to Witness Robust Expansion by 2025. OpenPR.