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PTC299

Phase 2

Metastatic Breast Cancer | Small molecule | Oncology |PTC Therapeutics, Inc.|Trials Updated: Mar 3, 2016

PTC299 development status

Highest phase Phase 2 (NCT00911248)
Phase scored for PTCTPhase 1
Registered trials 5 across 1 sponsor since Jul 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

PTC299 clinical trials

PTC299 · 1 trial · 1 indication

Phase 1 1
NCT00508586PTC299 and Hormonal Agent for Treatment of Metastatic Breast CancerMetastatic Breast Cancer
COMPLETED33 Analytics
PHASE1COMPLETED
PTC299 and Hormonal Agent for Treatment of Metastatic Breast Cancer
Metastatic Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose (MTD) within the tested dose range.
6 Weeks

Secondary Endpoints

Overall safety profile
6 Weeks
Study drug compliance
6 Weeks
Pharmacokinetics
6 Weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPTC299 with an aromatase inhibitor

Interventions

NameTypeDescription
PTC299DRUGPTC299 orally administered twice per day given in combination with anastrozole (Arimidex®), letrazole (Femara®), or exemestane (Aromasin®)
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites3

Major Eligibility Criteria: 1. Female sex. 2. Age ≥18 years. 3. Body weight 40-100 kg. 4. ECOG performance status of 0 or 1. 5. Histologically or cytologically confirmed adenocarcinoma of the breast. 6. Presence of metastatic disease not amenable to surgery, radiation therapy, or chemoradiotherapy ...

Countries:United States
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Competitive Landscape -Breast Cancer 609 trials (matched to "Metastatic Breast Cancer")

Frequently asked questions about PTC299

What is PTC299 used for in metastatic breast cancer?

PTC299 is an investigational small molecule being studied for the treatment of metastatic breast cancer. It was evaluated in a Phase 1 clinical trial in combination with a hormonal agent. The study enrolled 33 female patients aged 18 years and older in the United States.

Who makes PTC299?

PTC299 is being developed by PTC Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol PTCT. The company conducted a Phase 1 clinical trial of PTC299 for metastatic breast cancer.

What phase is PTC299 in?

PTC299 is in Phase 1 clinical development. It has completed one Phase 1 trial for metastatic breast cancer. PTC299 is investigational and has not been approved by the FDA, as it remains in early-stage clinical development.

What clinical trials is PTC299 in?

PTC299 has been studied in one completed clinical trial, NCT00508586, titled "PTC299 and Hormonal Agent for Treatment of Metastatic Breast Cancer." This Phase 1 study enrolled 33 female participants with metastatic breast cancer in the United States.

Is PTC299 FDA approved?

PTC299 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial for metastatic breast cancer. The drug remains in clinical development and has not received regulatory approval for any indication.