Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01392521 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Study of PI3(Phosphoinositol 3)-Kinase Inhibitor Copanlisib With MEK (Mitogen-activated Protein Kinase) Inhibitor Refametinib (BAY86-9766) in Patients With Advanced Cancer
A Phase 1 study of Neoplasms, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 8
- Study locations
NCT01392521: Completed Phase 1 study of Neoplasms, sponsored by Bayer.
NCT01392521 is a Phase 1 study of Neoplasms that has completed, run by Bayer. The registered enrollment target is 64 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01392521, a Phase 1 study of Neoplasms, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 8
- Study locations
Study Summary
The PI3K (phosphoinositol 3-Kinase) inhibitor Copanlisib and the MEK (mitogen-activated protein kinase) inhibitor Refametinib (BAY86-9766)have both been tested as single agent treatments in other phase I studies. This study will test the combination of these two drugs to try and answer the following questions: 1. What are the side effects of the combination of Copanlisib and Refametinib (BAY86-9766)when given together at different/increasing dose levels? 2. What dose level of Copanlisib and Refametinib (BAY86-9766) should be tested in future clinical research studies? 3. How much Copanlisib is in the blood at specific times after administration and does adding Refametinib (BAY86-9766) have an affect? 4. How much Refametinib (BAY86-9766) is in the blood at specific times after administration and does adding Copanlisib have an affect? 5. Does the combination of Refametinib (BAY86-9766) and Copanlisib have an effect on tumors?
Conditions Studied
Interventions
- DRUG Copanlisib + Refametinib (BAY86-9766)
Study Locations (8)
Texas
- - Houston
- - Tyler
Arizona
- - Scottsdale
Nevada
- - Las Vegas
South Carolina
- - Greenville
Washington
- - Vancouver
Baden-Wurttemberg
- - Freiburg im Breisgau
Other
- - Rotterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT01392521 record still lists
NCT01392521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Copanlisib + Refametinib (BAY86-9766) is the first listed.
NCT01392521 lists 8 locations in 7 states (Texas, Arizona, Nevada).
Frequently Asked Questions
What is clinical trial NCT01392521 about?
NCT01392521 is a clinical study titled "Phase Ib Study of PI3(Phosphoinositol 3)-Kinase Inhibitor Copanlisib With MEK (Mitogen-activated Protein Kinase) Inhibitor Refametinib (BAY86-9766) in Patients With Advanced Cancer". The PI3K (phosphoinositol 3-Kinase) inhibitor Copanlisib and the MEK (mitogen-activated protein kinase) inhibitor Refametinib (BAY86-9766)have both been tested as single agent treatments in other phase I studies. This study will test the combination of these two drugs to try and answer the following...
What is the current status of trial NCT01392521?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2011-07. Estimated completion is 2014-04.
What conditions does trial NCT01392521 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT01392521?
The interventions under investigation include: Copanlisib + Refametinib (BAY86-9766) (DRUG).
Who is sponsoring clinical trial NCT01392521?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01392521 being conducted?
This trial has 8 study locations across Arizona, Nevada, South Carolina, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01392521's enrollment target sits among peer trials
64 92nd of 158 higher than 66 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)
RECRUITING · Phase 1
-
A Study of GSK5764227 in Participants With. Advanced Solid Tumors (EMBOLD PanTumor-101)
RECRUITING · Phase 1
-
Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
RECRUITING · Phase 1
-
Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
RECRUITING · Phase 1
-
Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01853631 · 64 participants · Phase 1
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
- NCT03739502 · 64 participants · Phase 2
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
- NCT03739814 · 64 participants · Phase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- NCT03866408 · 64 participants · Early Phase 1
Insulin Regulation of Lipolysis and Lipolysis Proteins
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia