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A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.

NCT02711345TerminatedPHASE1INTERVENTIONAL

Summary

A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.

Key Facts

Lead Sponsor

Novartis Pharmaceuticals

Enrollment

Start Date

2016-04-15

Completion Date

2018-11-21

Study Type

INTERVENTIONAL

Official Title

A Phase I Dose Finding Study of Oral LTT462 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations.

Interventions

LTT462

Conditions

Ovarian NeoplasmsNon-Small-Cell Lung CarcinomaMelanomaOther Solid Tumors

Eligibility

Age Range

12 Years+

Sex

ALL

Inclusion Criteria:

* Patient (male or female) ≥12 years of age
* ECOG (Eastern Cooperative Oncology Group) performance status ≤1
* Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.
* Patients must be willing and able to undergo study required biopsies.
* Presence of at least one measurable lesion according to RECIST v1.1.
* Documented MAPK pathway alteration

Exclusion Criteria:

* Prior treatment with ERK inhibitors.
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
* Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
* Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
* Patients with malignant disease other than that being treated in the study.
* Clinically significant cardiac disease.

Other protocol-defined exclusion criteria may apply.

Outcome Measures

Primary Outcomes

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An adverse events is defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occur after participant's signed informed consent has been obtained. A SAE is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.

Time frame: Up to 2.8 years

Percentage of Participants With Dose Limiting Toxicities (DLTs)

Percentage of participants with dose limiting toxicity were reported.

Time frame: Up to 2.8 years

Percentage of Participants With at Least One Dose Reduction

Percentage of participants with at least one dose reduction were reported.

Time frame: Up to 2.8 years

Percentage of Participants With at Least One Dose Interruptions

Percentage of participants with at least dose interruptions were reported.

Time frame: Up to 2.8 years

Dose Intensity Received by Participants

Dose intensity of LTT462 received by treatment group was reported.

Time frame: Up to 2.8 years