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HYCAMTIN

Phase 3

Lung Cancer, Non-Small Cell | Small molecule | Oncology |GSK plc|Last Updated: Jan 20, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment472

FDA Designations

No designations recorded

Clinical trial landscape

HYCAMTIN · 1 trial · 1 indication

Phase 3 1
NCT00390806Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung CancerLung Cancer, Non-Small Cell
COMPLETED472 Analytics
PHASE3COMPLETED
Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer
Lung Cancer, Non-Small CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival
From the time of Randomization until the date of death due to any cause (up to 195 weeks)

Overall survival is defined as the time from randomization until the date of death due to any cause. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.

Secondary Endpoints

Six-month Survival
Month 6
Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic)
From the time of Randomization until the time of CR or PR (up to 75 weeks)
Time to Response (TTR) (CNS-radiologic)
From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
topotecan plus radiationEXPERIMENTALtopotecan 1.1 mg/m2 followed by whole brain radiation 3 Gy/day for 10 days, followed by optional continuation therapy with topotecan 2.3 mg/m2 for 5 days Q21 days as monotherapy.
Whole brain radiationACTIVE_COMPARATORWhole brain radiation 3 Gy/day for 10 days

Interventions

NameTypeDescription
HYCAMTIN, oral capsulesDRUGtopotecan oral capsules 1.1 mg/m2
RadiationRADIATIONWhole brain radiation
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites88

Inclusion criteria: * At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC) * Must have received previous chemotherapy * Must be 18 years of age of greater * Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2 * At least 2 week...

Countries:United StatesCanadaHungaryPolandRussiaSlovakia
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Frequently asked questions about HYCAMTIN

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

HYCAMTIN is a small molecule being studied for the treatment of Non-Small Cell Lung Cancer, specifically for brain metastases resulting from this cancer. It is an investigational drug in Phase 3 clinical development, and it is not yet approved for this use.

What does HYCAMTIN target?

HYCAMTIN is a small molecule, but its specific molecular target is not disclosed in the available information. It is being investigated for its potential role in treating brain metastases from Non-Small Cell Lung Cancer.

Who makes HYCAMTIN?

HYCAMTIN is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is HYCAMTIN in?

HYCAMTIN is in Phase 3 clinical development for Non-Small Cell Lung Cancer. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to determine its safety and effectiveness.

What clinical trials is HYCAMTIN in?

HYCAMTIN has one completed Phase 3 clinical trial, identified as NCT00390806. This trial studied oral HYCAMTIN plus whole brain radiation therapy in the treatment of brain metastases resulting from Non-Small Cell Lung Cancer, enrolling 472 participants.

Is HYCAMTIN the same as topotecan?

HYCAMTIN is a brand name for the drug topotecan, which is a chemotherapy agent. In the context of the available information, HYCAMTIN refers to this drug, and it is being investigated for use in Non-Small Cell Lung Cancer with brain metastases.