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Anti-microtubule agent

ORIC-101 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Oric Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, ORIC-101, to see what the best dose is and how well it works with other cancer drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part I: Recommended Phase 2 Dose (RP2D)
Part II: Objective Response Rate (ORR)
Secondary outcome measures
Part I: Area under the curve (AUC(0-t))
Part I: Maximum plasma concentration (Cmax)
Part I: Number of Participants with Antitumor Activity
+9 more
Other outcome measures
Parts I and II: Number of Participants with GR Expression by IHC

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Expansion (Part II)Experimental Treatment2 Interventions
RP2D dose
Group II: Dose Escalation (Part I)Experimental Treatment2 Interventions
ORIC-101 dosed orally, once per day, for 5 or 7 days/week in combination with nab-paclitaxel (75 or 100 mg/m2 on Days 1, 8, and 15) of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ORIC-101
2018
Completed Phase 1
~60
Nab-paclitaxel
2014
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

Oric PharmaceuticalsLead Sponsor
3 Previous Clinical Trials
146 Total Patients Enrolled
ORIC PharmaceuticalsLead Sponsor
7 Previous Clinical Trials
556 Total Patients Enrolled
Pratik S. Multani, MDStudy DirectorORIC Pharmaceuticals
3 Previous Clinical Trials
188 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What condition has ORIC-101 been shown to most effectively address?

"ORIC-101 is a medication commonly employed to combat ill effects from neoplasm metastasis, as well as advanced directives, Kaposi sarcoma, and fallopian tubes cancer."

Answered by AI

Has there been precedent research related to the utilization of ORIC-101?

"Presently, 832 studies exploring ORIC-101 are in progress--227 of which have achieved Phase 3. Melbourne is the primary location for research concerning this medication; however, there are 45681 other sites across the globe studying its efficacy as well."

Answered by AI

Has ORIC-101 obtained regulatory approval from the FDA?

"There is minimal evidence of the safety and efficiency ORIC-101, so it has been given a 1 on our team's rating scale."

Answered by AI

What are the anticipated outcomes of this research endeavor?

"ORIC Pharmaceuticals, the sponsor of this clinical trial, has stated that the primary goal measured over an 18-month period is determining Recommended Phase 2 Dose (RP2D). Additionally, researchers will be evaluating Abnormal Vital Signs in relation to safety and tolerability of ORIC-101 in combination with nab-pacitaxel as well as examining Area under the Curve (AUC(0-t)) regarding pharmacokinetics. Finally, they are assessing Adverse Events associated with ORIC-101 combined with nab-paclitaxel."

Answered by AI

Are any volunteers being accepted for this trial at the present time?

"According to clinicaltrials.gov, this trial is not currently recruiting participants, having been initially posted on May 2nd 2019 and last edited on September 22th 2022. That said, there are many other trials available that are actively seeking patients at the present time - 1282 in total!"

Answered by AI

How many participants are accepted into this research project?

"This trial has already closed, as it was last updated on September 22nd 2022. If you are searching for alternative trials, there are 450 studies recruiting patients with tumors and 832 accepting participants for ORIC-101."

Answered by AI

How many facilities are involved in conducting this experiment?

"Texas MD Anderson Cancer Centre, Virginia Cancer Specialists, and NEXT Oncology in San Antonio are among the 12 clinical trial sites for this medical experiment."

Answered by AI
~14 spots leftby Apr 2025