Ovarian Cancer Clinical Trial
Official title:
A Phase II, 2-stage Trial of CRLX101 in Combination With Bevacizumab in Recurrent Platinum-Resistant Ovarian, Tubal and Peritoneal Cancer
This research study is a Phase II clinical trial. In addition to studying safety, Phase II
clinical trials test if the investigational drug is effective and whether the drug works in
treating a specific cancer. "Investigational" means that the drug is still being studied and
that research doctors are trying to find out more about it-such as the safest dose to use,
the side effects it may cause, and if the drug is effective for treating different types of
cancer. It also means that the FDA (the U.S. Food and Drug Administration) has not yet
approved CRLX101 for your type of cancer.
Camptothecin is a chemical extracted from plants that is the basis for the standard
FDA-approved chemotherapy drugs irinotecan and topotecan. Camptothecin works by interfering
with the way cells divide and multiply. The investigational drug CRLX101 is a formulation of
camptothecin and a large molecule (nanoparticle)that appears to allow more of the
camptothecin to get into tumors and stay in tumors. The persistence of the CRLX101 in the
tumor may increase the probability that the tumor cells will be damaged.
CRLX101 has been well tolerated in the laboratory and in participants with different kinds of
cancer.
Bevacizumab (Avastin) is a VEGF inhibitor which has activity in many kinds of cancer.
Bevacizumab has been successfully combined with many chemotherapy partners.
It has been hypothesized that the combination of bevacizumab with CRLX101 might have unique
clinical activity in combination in the treatment of this disease due to the simultaneous
inhibition of distinct steps along the HIF → (CAIX) → VEGF → VEGFR2 pathway. Specifically, it
is hypothesized that CRLX101-mediated inhibition of HIF-1α carries with it the potential to
interrupt hypoxia and HIF-1α-associated resistance to VEGFR inhibitors. It is hoped that this
combination will work to treat your type of cancer.
You will receive CRLX101 and bevacizumab through an intravenous (IV) infusion once every 14
days. Each cycle is 28 days. You will continue to receive both drugs until you and/or the
research doctor decides it may not be in your best interest to continue.
You will receive premedication including decadron, zantac and benadryl to help prevent an
allergic reaction and nausea prior to your CRLX101 infusion.You will also receive IV fluid
before and after the study drug administration to keep you hydrated. It will be important for
you to drink water regularly in between study visits.You will be treated as an outpatient. At
every clinic visit, you will undergo the following assessments: Medical history, physical
examination, vital signs, performance status, routine blood tests, urine tests, assessment
for any new side effects, CT evaluation (every 8 weeks).
You will have an end of study visit within 30 days of your last dose.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Withdrawn |
NCT05201001 -
APX005M in Patients With Recurrent Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
| Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05156892 -
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
|
Phase 1 | |
| Suspended |
NCT02432378 -
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04533763 -
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
|
N/A | |
| Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
| Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
| Completed |
NCT01936363 -
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT02019524 -
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
|
Phase 1 | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Terminated |
NCT03146663 -
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
|
Phase 2 |