NCT02635672CompletedPhase 1
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer
An Open-label, Multicenter Phase I Dose Escalation Study to Characterize Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of VIP152 (BAY 1251152) as Monotherapy or Combination Therapy in Subjects With Advanced Cancer.
Source: ClinicalTrials.gov · Last updated 15 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 17 Dec 2015
- Start date
- 10 Feb 2016
- Primary completion date
- 11 Nov 2024
- Lead sponsor
- Vincerx Pharma, Inc.
- Diseases
- Prostate cancer, Triple-negative breast cancer, Follicular lymphoma, Mantle cell lymphoma, Kidney cancer, Bladder cancer, Melanoma, Endometrial cancer, Cervical cancer, Lung cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT02635672
- EudraCT number
- 2014-004808-30
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 110
- From 10 Feb 2016 to the primary completion date, 11 Nov 2024
- 16 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticancer chemotherapy or immunotherapy during the study or within 1 weeks prior to the first dose of study drug
- Major surgery or significant trauma within 4 weeks before the first dose of study drug
- Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment.
Other illness
- Active clinically serious infections of events \> Grade 2
Other
- Subjects who have new or progressive brain or meningeal or spinal metastases.
Who the study is looking for
- Male or female patients aged \>/=18 years
- Patients with a histologically or cytologically confirmed solid tumor or aggressive NHL who are refractory to or have exhausted all available therapies with MYC expression or known C-MYC amplification/alterations
- Adequate bone marrow, liver, and renal functions
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- In the addition to the above Part 3 (US Only) and Part 4 (US Only)
- Must be eligible to use pembrolizumab per USPI
Criteria the registry did not label
- Part 2 (Global), Part 3 (US Only), and Part 4 (US Only)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Investigaciones Clinicas Vina Del Mar Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Oncocentro Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| START Madrid Fundacion Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| NEXT Oncology Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Willamette Valley Cancer Institute Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| John Theurer Cancer Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Maryland Oncology Hematology Coordinator of this site? Confirm its status | Silver Spring | United States | Unknown status |
| Avera Health Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Highlands Oncology Group Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.