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Doxycline

Phase 2

Non-Small Cell Lung Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Feb 25, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment147

FDA Designations

No designations recorded

Clinical trial landscape

Doxycline · 1 trial · 1 indication

Phase 2 1
NCT00531934A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.Non-Small Cell Lung Cancer
COMPLETED147 Analytics
PHASE2COMPLETED
A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment
Days 0, 14, 28 and Months 2, 3, and 4

Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation.

Secondary Endpoints

Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment
Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type
Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity
Days 0, 14, 28 and Months 2, 3, and 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
DoxyclineDRUG100mg po daily
erlotinib [Tarceva]DRUG150mg po daily
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * adult patients, 18-75 years of age; * confirmed non-small cell lung cancer; * failure after first line chemotherapy for advanced disease, and scheduled for second line therapy with Tarceva. Exclusion Criteria: * rash of any etiology at study entry; * history of significant h...

Countries:France
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about Doxycline

What is Doxycline used for in Non-Small Cell Lung Cancer?

Doxycline is an investigational small molecule being studied for use in Non-Small Cell Lung Cancer (NSCLC). It is currently in Phase 2 clinical development, with one completed trial that enrolled 147 patients in France. The drug is being developed by Roche Holding AG.

How does Doxycline work?

The molecular target and target class for Doxycline have not been disclosed in the available information. As a small molecule, it is being investigated for its potential role in managing Non-Small Cell Lung Cancer, but its specific mechanism of action is not publicly detailed.

Who makes Doxycline?

Doxycline is being developed by Roche Holding AG, a biopharmaceutical company. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Non-Small Cell Lung Cancer.

What phase is Doxycline in?

Doxycline is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 2 trial has been completed, and the drug remains under evaluation for Non-Small Cell Lung Cancer.

What clinical trials is Doxycline in?

Doxycline has one completed clinical trial, NCT00531934, titled 'A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.' This Phase 2 study enrolled 147 patients in France and was active-controlled, though it is no longer ongoing.

Is Doxycline the same as Tarceva?

No, Doxycline is not the same as Tarceva. The completed trial NCT00531934 studied the management of Tarceva-induced rash in Non-Small Cell Lung Cancer patients, indicating Doxycline was evaluated as an adjunct therapy to manage side effects, not as a substitute for Tarceva.