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Tyrosine Kinase Inhibitor

Lucitanib for Solid Tumors

Phase 1 & 2
Waitlist Available
Led By Nicole Concin, MD
Research Sponsored by Clovis Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years of age
Adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug until disease progression (up to approximately 2 years)
Awards & highlights

Study Summary

This trial is testing a new cancer drug, lucitanib, to see if it is safe and effective when used with nivolumab to treat advanced solid tumors. The trial will also look at whether it matters if patients take the drug with or without food.

Eligible Conditions
  • Solid Tumors
  • Gynecologic Cancers

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug until disease progression (up to approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug until disease progression (up to approximately 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Overall Response Rate (Phase 2)
Determine the recommended Phase 2 dose of the combination of lucitanib and nivolumab (Phase 1b)
Secondary outcome measures
Acute and long-term safety and tolerability of the combination (Phase 2)
Further evaluation of preliminary efficacy of combination (Phase 2)
Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect, Phase 2]
+3 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase 2: Expansion Cohort - Ovarian CancerExperimental Treatment2 Interventions
Recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma At least 2 prior chemotherapy regimens which at least 1 must have been platinum-doublet chemotherapy Up to 10 subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma who have progressed within 6 months after completing first-line platinum-based chemotherapy will be allowed to enroll
Group II: Phase 2: Expansion Cohort - Endometrial CancerExperimental Treatment2 Interventions
Recurrent endometrial carcinoma at least 1 prior platinum-based chemotherapy regimen Up to 10 patients who have progressed on treatment with 1 prior PD-(L)1 inhibitor administered as monotherapy will be allowed to enroll
Group III: Phase 2: Expansion Cohort - Clear Cell CancerExperimental Treatment2 Interventions
Recurrent, metastatic clear cell carcinoma of ovarian, fallopian tube, primary peritoneal or endometrial origin At least 1 prior platinum- and taxane-based chemotherapy regimen
Group IV: Phase 2: Expansion Cohort - Cervical CancerExperimental Treatment2 Interventions
Persistent or recurrent cervix cancer of squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma histology At least 1 prior regimen of platinum-based chemotherapy, with or without bevacizumab, for metastatic disease
Group V: Phase 1b: Food Effect CohortExperimental Treatment2 Interventions
- Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled
Group VI: Phase 1b: Dose EscalationExperimental Treatment2 Interventions
- Up to 50 patients with advanced solid tumor
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Lucitanib
2014
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,309 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
16,412 Total Patients Enrolled
Clovis Oncology, Inc.Lead Sponsor
63 Previous Clinical Trials
9,944 Total Patients Enrolled

Frequently Asked Questions

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

Is this a recent clinical trial?

"Lucitanib has been under investigation for a little over a decade. In 2010, the first clinical trial evaluating Lucitanib's safety and efficacy was conducted. This study, sponsored by Medarex, enrolled 127 patients. After the initial study in 2010, Lucitanib was approved for Phase 1 clinical trials. Presently, there are 753 live studies involving Lucitanib being conducted in 2357 cities across 50 different countries."

Answered by AI

Are there any ongoing or previous studies that have used Lucitanib?

"As of now, 753 different active clinical trials are researching Lucitanib. Out of these, 84 have reached Phase 3. Additionally, while there are many trials based out of Ciudad de Mexico and Maryland, 40516 different locations are running clinical trials for Lucitanib."

Answered by AI

What is the total number of volunteers for this clinical trial?

"This trial is not seeking new participants at the moment. The listing was created on 29th July 2019 and was last updated on 21st July 2020. There are 2630 other cancer trials and 753 Lucitanib trials currently looking for patients."

Answered by AI

What are the common diseases that Lucitanib is used to target?

"Lucitanib can be used as an effective treatment against malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI
~40 spots leftby Mar 2025