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XRP6976

Phase 3

Cancer | Small molecule | Oncology |Sanofi|Last Updated: Apr 29, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Clinical trial landscape

XRP6976 · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00273546Induction Chemotherapy Comparing Taxotere® Cisplatin and 5-Fluorouracil (TPF) With Standard Cisplatin and 5-Fluorouracil (PF) Followed by Chemoradiation in Locally Advanced Head and Neck CancerCancer
COMPLETED500 Analytics
PHASE3COMPLETED
Induction Chemotherapy Comparing Taxotere® Cisplatin and 5-Fluorouracil (TPF) With Standard Cisplatin and 5-Fluorouracil (PF) Followed by Chemoradiation in Locally Advanced Head and Neck Cancer
Cancer
NCT00273546500
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Study Endpoints

Primary Endpoints

Overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5-FU) or the control treatment (PF: Cisplatin plus 5-FU) followed by chemoradiotherapy.
to detect a significant increase in time to progression in favor of docetaxel plus cisplatin and 5-FU compared to cisplatin plus 5-FU. Tumor assessments (assessed with WHO criteria) had to be performed every 8 weeks until progression

Secondary Endpoints

The main secondary outcome is progression free survival (PFS).
The other secondary endpoints are improvement of local symptoms;time-to-treatment failure;quality of life;
clinical complete response rate (CR) and overall response rate(PR+CR) after chemotherapy and after locoregional therapy(chemoradiotherapy);
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
XRP6976 (Docetaxel/Taxotere)DRUG -
XRP6976DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * 1.Histologically or cytologically proven squamous cell carcinoma of the head/neck. * 2.Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx, larynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiv...

Countries:United StatesArgentinaCanadaFrancePortugalRussia
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Competitive Landscape -Cancer 5 trials

CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520/ GEH200521- Part A
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Frequently asked questions about XRP6976

What is XRP6976 used for?

XRP6976 is an investigational small molecule being studied for the treatment of cancer, specifically stomach neoplasm. It is in clinical development for oncology indications, with trials conducted in patients with advanced gastric cancer and head and neck cancer.

Who makes XRP6976?

XRP6976 is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in cancer patients.

What phase is XRP6976 in?

XRP6976 is in Phase 3 clinical development. It has completed a Phase 3 trial for head and neck cancer and a Phase 2 trial for stomach neoplasm. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is XRP6976 in?

XRP6976 has been studied in two completed clinical trials. NCT00273546 was a Phase 3 trial in head and neck cancer with 500 participants, and NCT00290966 was a Phase 2 trial in advanced gastric cancer with 610 participants. Both trials are completed.

How does XRP6976 work?

XRP6976 is a small molecule, but its specific molecular target has not been disclosed in available information. It is being evaluated as part of combination chemotherapy regimens for the treatment of certain cancers.

Is XRP6976 the same as docetaxel?

XRP6976 is not the same as docetaxel. The clinical trials listed for XRP6976 compare regimens containing docetaxel, cisplatin, and 5-fluorouracil against standard treatments, but XRP6976 itself is a distinct investigational drug being developed by Sanofi.