Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    VIP152

Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02635672
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Vincerx Pharma, Inc.

Brief Summary:
Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).

Condition or disease Intervention/treatment Phase
Neoplasms Drug: VIP152 (BAY 1251152) Drug: VIP152 (BAY 1251152) 30 mg Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 107 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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) in Patients With Advanced Cancer.
Actual Study Start Date : February 10, 2016
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose escalation of VIP152 (BAY 1251152) / PART 1 (Completed)
Investigating VIP152 (BAY 1251152) in a dose escalation cohort in patients with solid tumors and aggressive NHL
Drug: VIP152 (BAY 1251152)
The starting dose of Cohort 1 will be 5 mg IV (30 minute infusion) fixed dose once weekly (5 mg/week) for 21 day cycles.

Experimental: Dose expansion of VIP152 (BAY 1251152) / PART 2
Investigating VIP152 (BAY 1251152) in a dose expansion cohort in patients with solid tumors and aggressive NHL
Drug: VIP152 (BAY 1251152) 30 mg
30 mg IV (30 minute infusion) fixed dose once weekly of a 21 day cycle.




Primary Outcome Measures :
  1. Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152) [ Time Frame: End of Cycle 1 / Day 21 ]
  2. Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1251152 [ Time Frame: Cycle1 / Day 1 (C1D1), C1D2,C1D3, C1D4, C1D8C1D15, C1D16,C1D17,C1D18,C2D1 ]
  3. Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP152 (BAY1251152) [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  4. AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of VIP152 (BAY1251152) [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  5. Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of BAY1251152 [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  6. AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of VIP152 (BAY1251152) [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  7. Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  8. Number of participants with adverse events as a measure safety and tolarability [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Tumor response evaluation based on the response criteria as applicable (RECIST v1.1 criteria for solid tumors and revised Lugano Classification for aggressive NHL) [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Active clinically serious infections of events > Grade 2
  • Subjects who have new or progressive brain or meningeal or spinal metastases.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635672


Contacts
Layout table for location contacts
Contact: Vincerx Clinical Trials Contact (+) 1-650-800-6676 clinicaltrials@vincerx.com

Locations
Layout table for location information
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Research Site         
United States, New Jersey
John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Research site         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Research site         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Research Site         
United States, Texas
NEXT Oncology Recruiting
Austin, Texas, United States, 78758
Contact: Research Site         
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Research Site         
Sponsors and Collaborators
Vincerx Pharma, Inc.
Investigators
Layout table for investigator information
Study Director: Vincerx Study Director Vincerx Pharma, Inc.
Additional Information:
Layout table for additonal information
Responsible Party: Vincerx Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02635672    
Other Study ID Numbers: VNC-152-101
2014-004808-30 ( EudraCT Number )
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vincerx Pharma, Inc.:
Solid tumors
Aggressive non-hodgkin's lymphoma (NHL)
Advanced Ovarian
Triple Negative Breast
DHL
Double-Hit Lymphoma
Follicular Lymphoma
Blastoid Mantle Cell
Prostate Cancer
MYC overexpression
MYC amplification
MYC translocation