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Last Updated: February 15, 2025

CLINICAL TRIALS PROFILE FOR STIVARGA


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All Clinical Trials for Stivarga

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01068769 ↗ Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor Completed Bayer Phase 2 2010-02-01 The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
NCT01068769 ↗ Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor Completed Brigham and Women's Hospital Phase 2 2010-02-01 The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
NCT01068769 ↗ Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor Completed Fox Chase Cancer Center Phase 2 2010-02-01 The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
NCT01068769 ↗ Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor Completed Massachusetts General Hospital Phase 2 2010-02-01 The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
NCT01068769 ↗ Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor Completed Oregon Health and Science University Phase 2 2010-02-01 The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
NCT01068769 ↗ Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor Completed Suzanne George, MD Phase 2 2010-02-01 The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Stivarga

Condition Name

Condition Name for Stivarga
Intervention Trials
Colorectal Cancer 8
Colorectal Neoplasms 8
Metastatic Colorectal Cancer 6
Stage IVC Colorectal Cancer AJCC v8 4
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Condition MeSH

Condition MeSH for Stivarga
Intervention Trials
Colorectal Neoplasms 33
Adenocarcinoma 11
Neoplasms 9
Carcinoma 8
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Clinical Trial Locations for Stivarga

Trials by Country

Trials by Country for Stivarga
Location Trials
United States 279
Australia 22
Japan 17
Italy 16
Canada 12
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Trials by US State

Trials by US State for Stivarga
Location Trials
California 21
Florida 18
North Carolina 15
Ohio 14
Minnesota 14
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Clinical Trial Progress for Stivarga

Clinical Trial Phase

Clinical Trial Phase for Stivarga
Clinical Trial Phase Trials
Phase 3 6
Phase 2/Phase 3 1
Phase 2 49
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Clinical Trial Status

Clinical Trial Status for Stivarga
Clinical Trial Phase Trials
Recruiting 25
Completed 20
Active, not recruiting 15
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Clinical Trial Sponsors for Stivarga

Sponsor Name

Sponsor Name for Stivarga
Sponsor Trials
Bayer 31
National Cancer Institute (NCI) 14
Academic and Community Cancer Research United 7
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Sponsor Type

Sponsor Type for Stivarga
Sponsor Trials
Other 101
Industry 75
NIH 14
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STIVARGA (Regorafenib): Clinical Trials, Market Analysis, and Projections

Introduction to STIVARGA

STIVARGA, also known as regorafenib, is a multitargeted kinase inhibitor developed by Bayer. It is used in the treatment of various cancers, including metastatic colorectal cancer (mCRC), unresectable hepatocellular carcinoma (HCC), and gastrointestinal stromal tumors (GIST).

Clinical Trials: CORRECT and Other Studies

CORRECT Trial

The CORRECT (COloRectal cancer treated with REgorafenib or plaCebo after failure of standard Therapy) trial was a pivotal phase 3 study that evaluated the efficacy and safety of STIVARGA in patients with mCRC who had progressed after all approved standard therapies. Here are the key findings:

  • Overall Survival (OS): STIVARGA demonstrated a median OS of 6.4 months compared to 5.0 months with placebo, showing a significant improvement in survival for previously treated patients with mCRC[1][3][4].
  • Progression-Free Survival (PFS): The trial showed a 51% reduction in the risk of disease progression or death with STIVARGA[1].
  • Disease Control Rate (DCR): STIVARGA achieved a DCR of 41% (including stable disease and partial response rates) versus 15% for the placebo group[1].
  • Treatment Sequencing: Patients in the CORRECT trial could receive cytotoxic therapy following STIVARGA, with 26% of patients receiving such treatment after STIVARGA[1].

Other Clinical Studies

  • GRID Study: In the GRID study, STIVARGA showed significant improvement in PFS compared to placebo in GIST patients with two or more prior lines of therapy[4].
  • RESORCE Trial: For HCC, STIVARGA has been approved as a second-line treatment option after progression with NEXAVAR (sorafenib), demonstrating improved OS and PFS in this patient population[4].

Safety and Tolerability

  • Adverse Reactions: Common adverse reactions in the CORRECT trial included hand-foot skin reaction, fatigue, diarrhea, hypertension, and rash. Dose interruptions and reductions were necessary in 61% and 38% of patients, respectively, due to adverse reactions[3].
  • Tolerance and Clinical Benefit: Patients who had difficulty tolerating NEXAVAR did not necessarily experience the same issues with STIVARGA, indicating that tolerance to one drug does not predict tolerance to the other[4].

Market Analysis

Current Market Size and Forecast

  • Global Market Size: As of 2024, the global regorafenib market size is estimated at USD 1558.5 million. It is projected to grow at a compound annual growth rate (CAGR) of 11.00% from 2024 to 2031[5].
  • Regional Breakdown: The market is segmented into North America, Europe, Asia Pacific, and Latin America. North America and Europe are significant contributors, with estimated sales revenues of USD 623.4 million and USD 467.55 million in 2024, respectively. The Asia Pacific region is expected to grow at a CAGR of 13% during the forecast period[5].

Sales Projections

  • Revenue Growth: The regorafenib market is expected to expand significantly, driven by increasing cancer incidence rates, particularly in colorectal cancer and HCC. Latin America, for instance, is expected to grow at a CAGR of 10.4% from 2024 to 2031, with countries like Brazil, Mexico, Argentina, and Chile being key contributors[5].

Competitive Landscape

  • Key Competitors: STIVARGA competes with other cancer therapies, including trifluridine/tipiracil and immunotherapies like Keytruda. However, STIVARGA's unique mechanism of action and its approval in multiple indications make it a significant player in the market[2][4].

Market Drivers and Challenges

Drivers

  • Increasing Cancer Incidence: Rising incidence rates of colorectal cancer and HCC are driving the demand for effective treatment options like STIVARGA[5].
  • Regulatory Approvals: Continuous regulatory approvals and expansions into new indications have supported the growth of the regorafenib market[4].
  • Strategic Collaborations: Collaborations between pharmaceutical companies and research institutions are fostering innovation and market expansion[2].

Challenges

  • Adverse Reactions: The side effect profile of STIVARGA, although manageable, can be a challenge for patient compliance and quality of life[3].
  • Competition from Immunotherapies: The emergence of immunotherapies, such as Keytruda, poses a competitive threat to traditional kinase inhibitors like STIVARGA[2].

Future Outlook

Clinical Trials and Research

  • Ongoing Trials: There are ongoing clinical trials, such as the Phase Ib trial combining STIVARGA with Keytruda, which aim to explore new treatment combinations and improve patient outcomes[2].

Market Expansion

  • Emerging Markets: The regorafenib market is expected to see significant growth in emerging markets, driven by increasing access to innovative treatments and regulatory approvals[5].

Key Takeaways

  • Clinical Efficacy: STIVARGA has demonstrated significant clinical efficacy in various cancer types, including mCRC, HCC, and GIST.
  • Market Growth: The global regorafenib market is projected to grow at a CAGR of 11.00% from 2024 to 2031.
  • Regional Opportunities: Emerging markets, particularly in Latin America, offer promising growth prospects.
  • Competitive Landscape: STIVARGA faces competition from other cancer therapies but remains a key player due to its unique mechanism and multiple approvals.

FAQs

What is STIVARGA used for?

STIVARGA (regorafenib) is used for the treatment of metastatic colorectal cancer (mCRC), unresectable hepatocellular carcinoma (HCC), and gastrointestinal stromal tumors (GIST).

What were the key findings of the CORRECT trial?

The CORRECT trial showed that STIVARGA improved overall survival (OS) and progression-free survival (PFS) in patients with mCRC who had progressed after all approved standard therapies.

How does STIVARGA compare to other cancer treatments?

STIVARGA competes with other cancer therapies, including trifluridine/tipiracil and immunotherapies like Keytruda, but its unique mechanism and multiple approvals make it a significant player in the market.

What is the projected market size of regorafenib by 2031?

The global regorafenib market is projected to grow at a CAGR of 11.00% from 2024 to 2031, with an estimated market size significantly higher than the current USD 1558.5 million.

What are the common adverse reactions associated with STIVARGA?

Common adverse reactions include hand-foot skin reaction, fatigue, diarrhea, hypertension, and rash, which may require dose interruptions or reductions.

How does the tolerance of NEXAVAR impact the use of STIVARGA in HCC patients?

Patients who had difficulty tolerating NEXAVAR did not necessarily experience the same issues with STIVARGA, indicating that tolerance to one drug does not predict tolerance to the other.

Sources

  1. STIVARGA® (regorafenib) Efficacy Data in CORRECT Trial. STIVARGA® (regorafenib) | HCP.
  2. Bayer's Phase Ib Stivarga with Merck's Keytruda efficacy/safety data. Clinical Trials Arena.
  3. Approval Package - STIVARGA (regorafenib). FDA.
  4. CORRECT and CONCUR Trials | Stivarga Global Website. STIVARGA.
  5. Regorafenib Market Will Grow at a CAGR of 11.00% from 2024 to 2031. Cognitive Market Research.

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