CLINICAL TRIALS PROFILE FOR OXALIPLATIN

505(b)(2) Clinical Trials for OXALIPLATIN

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	NCT00215982 ↗	Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer	Completed	Roche Pharma AG	Phase 2	2004-12-01	The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination	NCT00215982 ↗	Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer	Completed	H. Lee Moffitt Cancer Center and Research Institute	Phase 2	2004-12-01	The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination	NCT00356122 ↗	Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)	Completed	Genentech, Inc.	Phase 2	2006-07-01	The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.
New Combination	NCT00356122 ↗	Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)	Completed	Sanofi	Phase 2	2006-07-01	The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.
New Combination	NCT00531245 ↗	A Phase I/II Trial of TS-1 and Oxaliplatin in Patients With Advanced Colorectal Cancer	Completed	Samsung Medical Center	Phase 1/Phase 2	2006-08-01	Capecitabine and oxaliplatin(XELOX) is active first-line therapy for patients with metastatic colorectal cancer. Phase II study of TS-1, a novel oral fluoropyrimidine derivative, showed activity in patients with metastatic colorectal carcinoma. Preclinical data of TS-1 with oxaliplatin showed synergistic activity in vivo human colorectal cancer xenograft. There is no data about the optimal dose of TS-1 with 2 weeks schedule combined with oxaliplatin. Therefore in a phase I study, we would like to determine the maximum tolerated dose(MTD) of TS-1 and oxaliplatin and define the recommended dose for subsequent phase II study. And then, in a phase II study we would like to evaluate the efficacy(response rates) and toxicities of the new combination regimen in advanced colorectal cancer.
New Combination	NCT01196260 ↗	Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III	Unknown status	Beihua University	Phase 2/Phase 3	2004-01-01	This study will examine a new combination of drugs: Capecitabine and Oxaliplatin for the treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination has a positive effect on metastatic colorectal cancer.

All Clinical Trials for OXALIPLATIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001835 ↗	Oxaliplatin in Cancer Patients With Impaired Kidney Function	Completed	National Cancer Institute (NCI)	Phase 1	1999-09-01	Oxaliplatin is an experimental anti-cancer drug that can shrink tumors such as colon cancer. However, because this drug can damage the kidneys, it is necessary to determine what doses of the drug can safely be given to patients with poor kidney function. Patients with advanced cancer, poorly functioning kidneys, and no good standard treatment options are eligible for this study. Candidates will be screened with imaging tests, such as CT and MRI scans, to determine the size and location of the cancer and with blood and urine tests to evaluate kidney and liver function. Study participants will receive oxaliplatin intravenously (through a vein) every 3 weeks for as long as the cancer is under control and there are no serious side effects from the drug. If significant side effects develop, the dosage will be reduced, or the drug will be stopped. Blood tests to measure blood cell counts will be done at least once a week, and CT scans, chest X-rays, and MRIs will be done about once every 6 weeks to assess the tumor's response to the treatment. Additional blood tests will be done at the beginning of the first two treatment cycles to measure the amount of oxaliplatin in the blood, and urine will be collected during the first 24 hours of drug treatment to determine how much drug is eliminated by the body in urine.
NCT00003260 ↗	Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer	Unknown status	GERCOR - Multidisciplinary Oncology Cooperative Group	Phase 3	1998-01-01	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 and giving the drugs in different combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil and leucovorin in treating recurrent metastatic colorectal cancer PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent metastatic colorectal cancer.
NCT00003260 ↗	Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer	Unknown status	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)	Phase 3	1998-01-01	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 and giving the drugs in different combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil and leucovorin in treating recurrent metastatic colorectal cancer PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent metastatic colorectal cancer.
NCT00003287 ↗	Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1998-03-01	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. It is not yet known which regimen of combination chemotherapy is more effective in treating patients with recurrent or metastatic colorectal cancer. PURPOSE: Randomized phase III trial to study the effectiveness of combining fluorouracil, leucovorin, and oxaliplatin in different ways in treating patients with recurrent or metastatic colorectal cancer.
NCT00003427 ↗	Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer	Completed	National Cancer Institute (NCI)	Phase 1	1998-04-01	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: Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating patients with previously treated metastatic gastrointestinal cancer that has not responded to previous treatment.
NCT00003427 ↗	Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer	Completed	Memorial Sloan Kettering Cancer Center	Phase 1	1998-04-01	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: Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating patients with previously treated metastatic gastrointestinal cancer that has not responded to previous treatment.

Clinical Trial Conditions for OXALIPLATIN

Condition Name

Condition Name for OXALIPLATIN
Intervention	Trials
Colorectal Cancer	361
Gastric Cancer	208
Metastatic Colorectal Cancer	145
Pancreatic Cancer	105

Condition MeSH

Condition MeSH for OXALIPLATIN
Intervention	Trials
Colorectal Neoplasms	763
Adenocarcinoma	373
Stomach Neoplasms	355
Rectal Neoplasms	231

Clinical Trial Locations for OXALIPLATIN

Trials by Country

Trials by Country for OXALIPLATIN
Location	Trials
Japan	435
Taiwan	94
Poland	81
Brazil	80
Netherlands	76

Trials by US State

Trials by US State for OXALIPLATIN
Location	Trials
California	261
New York	219
Texas	205
Ohio	173
Florida	171

Clinical Trial Progress for OXALIPLATIN

Clinical Trial Phase

Clinical Trial Phase for OXALIPLATIN
Clinical Trial Phase	Trials
PHASE4	7
PHASE3	52
PHASE2	200

Clinical Trial Status

Clinical Trial Status for OXALIPLATIN
Clinical Trial Phase	Trials
Completed	762
Recruiting	608
Unknown status	268

Clinical Trial Sponsors for OXALIPLATIN

Sponsor Name

Sponsor Name for OXALIPLATIN
Sponsor	Trials
National Cancer Institute (NCI)	267
Sanofi	132
Sun Yat-sen University	94

Sponsor Type

Sponsor Type for OXALIPLATIN
Sponsor	Trials
Other	2748
Industry	1035
NIH	269

Oxaliplatin clinical trials update, market analysis, and sales projection (global and major markets)

Last updated: May 20, 2026

Executive summary: Oxaliplatin is an established, off-patent platinum chemotherapy with broad global uptake in colorectal and other solid tumors. Most incremental value today comes from (1) expansion in combination regimens, (2) biomarker-enriched use, (3) delivery and administration refinements, and (4) competitive share shifts among generic entrants and original-brand channel dynamics. The near-term market is driven by colorectal cancer incidence and regimen selection in first-line (FOLFOX/related) and adjuvant settings, offset by generic penetration and price compression. Current clinical trial activity is concentrated in regimen optimization, sequencing, and novel combinations rather than new oxaliplatin molecules. Public trial enrollment signals point to continued use in solid-tumor strategies through at least the next 3 to 5 years, with growth more dependent on trial-driven indications and protocol standardization than on new patents.

What is the current clinical trials landscape for oxaliplatin?

Answer: Clinical activity centers on oxaliplatin-based chemotherapy combinations in gastrointestinal and other solid tumors, including trials testing new targeted agents, immunotherapy combinations, and biomarker-stratified arms. Most studies are late-stage or randomized comparisons designed to define regimen positioning, duration, and sequencing rather than replace oxaliplatin.

Which trial phases dominate oxaliplatin updates?

• Phase 3: Comparative regimen studies and combinations intended to change standards of care, typically in metastatic colorectal cancer (mCRC) and perioperative/adjuvant settings.
• Phase 2: Signal-seeking combination trials in specific molecular subgroups, prior therapy lines, and enriched populations.
• Phase 1/1b: Combination safety and dose optimization where oxaliplatin is layered with novel agents (targeted therapies and immuno-oncology).
• Phase 4 / comparative effectiveness: Real-world regimen, dose intensity, safety/tolerability, and administration optimization, often with older backbone chemotherapies.

What are the main clinical trial themes using oxaliplatin?

1. Combination intensification and de-escalation
   • Comparing standard FOLFOX-like regimens with shortened duration, reduced-intensity strategies, or alternative schedules to maintain efficacy while reducing toxicity.
2. Immuno-oncology and targeted combinations
   • Trials evaluating oxaliplatin backbones with immune checkpoint inhibitors and targeted agents across biomarker-defined cohorts.
3. Biomarker stratification
   • Enrollment enrichment or stratified analyses based on molecular markers relevant to colorectal tumor biology and platinum sensitivity.
4. Sequence and line-of-therapy positioning
   • Studies designed to define the best order of oxaliplatin exposure relative to targeted therapy and immunotherapy.

What market does oxaliplatin serve and what are the key demand drivers?

Answer: Oxaliplatin demand is primarily tied to colorectal cancer treatment pathways, with additional use in selected other solid tumors where platinum-based chemotherapy remains standard or used in defined combinations.

Primary tumor indications driving demand

• Colorectal cancer
  • Adjuvant and metastatic settings are the largest drivers because FOLFOX and related regimens are standard-of-care across many geographies and practice patterns.
• Other solid tumors
  • Use exists in select non-colorectal oncology settings, generally as combination chemotherapy, but at a smaller scale than colorectal.

Regimen selection and treatment pathway mechanics

• Oxaliplatin is a backbone in FOLFOX (oxaliplatin + leucovorin + 5-FU) and related permutations.
• Treatment duration and dosing schedules influence total drug demand and patient-level utilization.
• Standardization of first-line pathways and adjuvant protocols shapes annual consumption.

How strong is the patent and exclusivity position for oxaliplatin?

Answer: Oxaliplatin is a widely available, off-patent oncology drug. The current market impact is driven far more by generic competition, pricing, and supply than by remaining brand exclusivity.

What does the patent estate look like today?

• For oxaliplatin, the patent regime largely completed decades ago for the active ingredient and basic composition use.
• Residual IP value today is typically concentrated in:
  • Formulation or manufacturing-process improvements (where applicable)
  • Device/administration logistics for specific presentations (where applicable)
  • Method-of-use in particular combinations or biomarker-defined settings

What does that mean commercially?

• The “IP moat” is not a primary driver of market size for oxaliplatin today.
• Pricing and availability dominate, and competitive advantage typically comes from:
  • Ability to supply at scale
  • Tender competitiveness and hospital formulary positioning
  • Batch consistency and regulatory acceptance

What is the Orange Book status of oxaliplatin?

Answer: Oxaliplatin is not characterized by an active, dominant single product exclusivity landscape that blocks generic entry in the U.S. The practical market reality is that oxaliplatin is broadly marketed, and buyers source based on price, supply reliability, and distribution networks.

How is oxaliplatin priced and where does cost pressure come from?

Answer: Pricing is structurally exposed to generics and tender-based hospital purchasing in most major markets. Cost pressure is strongest where multiple manufacturers can qualify and where reimbursement is flat or diagnosis-related.

Key commercial price drivers

• Generic penetration and multiple supply sources
• Tender and contracting cycles
• Exchange-rate volatility for procurement and active ingredient inputs
• Oncology drug budget constraints and budget caps
• Clinical guideline adherence that standardizes backbone chemotherapy selection

Oxaliplatin sales projection: what does the next 3 to 5 years look like?

Answer: Base-case growth is modest and largely volume-led, not price-led, with annual market evolution dominated by:

• Stabilization or incremental expansion of colorectal chemotherapy participation
• Uptake of oxaliplatin-containing regimens in combinations and perioperative pathways
• Ongoing price compression in competitive tenders and replenishment cycles
• Manufacturing and supply continuity

Market projection framework (what drives the numbers)

Use patient numbers and regimen intensity as the mechanical backbone:

• Incidence and treatment eligibility in colorectal cancer
• Line-of-therapy persistence where oxaliplatin remains part of standardized protocols
• Dose intensity and duration based on protocol standard-of-care
• Share of chemotherapy vs targeted/immunotherapy regimens (oxaliplatin remains a backbone where used)
• Generic mix and realized price per unit

Base-case outlook (directional)

• Volume: Gradual increase or stable demand where colorectal screening and diagnosis cycles sustain treatment volumes.
• Value: Flat to low growth globally due to continued price compression.
• Competitive risk: Supply constraints or manufacturing quality issues can produce short-term pricing and availability spikes, but the baseline remains competitive.

Which companies dominate oxaliplatin supply in key markets?

Answer: Oxaliplatin supply in most markets is provided by the original brand and a broad generic ecosystem. Dominance depends on hospital tender structures, distribution strength, regulatory approvals, and local manufacturing or packaging.

What determines “share” beyond brand vs generic?

• Contracting and inclusion in oncology formularies
• Competitive pricing in regional tenders
• Distribution reach into oncology centers
• Lead-time reliability and lot-to-lot quality acceptance
• Substitution rules and procurement policies

How do oxaliplatin clinical outcomes influence market positioning?

Answer: Oxaliplatin’s clinical role is defined by proven efficacy in standard colorectal chemotherapy backbones and its survivorship impact when integrated into multimodality care.

What outcomes matter for purchasing decisions?

• Protocol guideline adherence (FOLFOX-like regimens remain common)
• Tolerability and safety management (particularly neuropathy risk)
• Practical administration and schedule fit in oncology clinics
• Comparative performance when combined with newer agents in late-stage studies

What are the biggest risks to oxaliplatin market growth?

Answer: Market upside is constrained by competitive pricing, shifting treatment paradigms, and substitution of chemotherapy backbones in certain biomarker-driven pathways.

Primary downside risks

1. Rapid substitution toward targeted and immuno-oncology regimens in biomarker-defined subgroups
2. Price compression from increased generic entrants and tender-driven contracting
3. Guideline changes that reduce oxaliplatin duration or replace FOLFOX backbones in specific settings
4. Safety-driven regimen changes that lower dose intensity or shift protocols

What generic entry risks exist for oxaliplatin?

Answer: Oxaliplatin has already experienced extensive generic entry in major markets. Ongoing “entry risk” is less about blocking barriers and more about:

• new packaging/presentation approvals,
• manufacturing qualification cycles,
• and periodic re-tendering that reselects suppliers.

How does oxaliplatin compare with cisplatin and carboplatin in competitive positioning?

Answer: Oxaliplatin has a differentiated backbone role in colorectal cancer compared with cisplatin or carboplatin, which have different toxicity profiles and evidence bases in different cancers. Market position is evidence-and-guideline driven rather than broad-spectrum substitution.

Commercial comparison logic

• Colorectal chemotherapy guidelines tend to favor oxaliplatin backbones in established regimens.
• Platinum selection is protocol- and tumor-specific, limiting direct substitution.

Key takeaways

• Oxaliplatin’s clinical trial activity is dominated by combination and sequencing optimization, not by new proprietary oxaliplatin molecules.
• Demand is anchored by colorectal cancer regimens (adjuvant and metastatic pathways), where oxaliplatin-containing backbones remain common.
• The market outlook is volume-supported but value-limited by ongoing generic competition and price compression.
• Near-term growth depends more on protocol positioning and patient-share than on IP-driven exclusivity.

FAQs

1. What types of late-stage trials are most likely to change oxaliplatin’s role in colorectal cancer?
2. How do hospital tender dynamics typically impact realized prices for oxaliplatin across EU and the U.S.?
3. Which biomarkers are most frequently used in oxaliplatin combination trial stratification in solid tumors?
4. What safety endpoints (neuropathy, hematologic toxicity) most influence dose intensity decisions for oxaliplatin regimens?
5. How do supply disruptions or manufacturing quality issues affect short-term oxaliplatin procurement and pricing?

References

1. [No sources cited because no bibliographic inputs or market/clinical datasets were provided in the prompt.]