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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04633239
Other study ID # NCI-2020-10084
Secondary ID NCI-2020-1008410
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 2, 2021
Est. completion date December 1, 2024

Study information

Verified date June 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I/Ib trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer.


Description:

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Study Design


Related Conditions & MeSH terms

  • Recurrence
  • Recurrent Platinum-Resistant Ovarian Carcinoma

Intervention

Drug:
Abemaciclib
Given PO
Procedure:
Biopsy
Undergo tumor biopsy
Biospecimen Collection
Undergo collection of blood
Drug:
Olaparib
Given PO

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Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Biomarker analysis Will measure proof of mechanism (RB, phosphoRB, cleaved caspase 3, Ki67, geminin, gamma-H2AX, RAD51 nuclear foci, pNBS multiplex, Myc transcriptional targets ODC1 and LDHA, homologous recombination genes BRCA1, BRCA2, RAD51, serum thymidine kinase), plasma and tumor pharmacokinetics, and subgroups of response (immunohistochemistry [IHC] for Myc, cyclin E; next generation sequencing [NGS]/whole exome sequencing [WES] for DCAF, hormone receptor [HR] repair gene alterations, Myc, and CCNE1; ribonucleic acid sequencing [RNAseq] for Myc and CCNE1). 30 days after completion of study treatment
Primary Recommended phase 2 dose (RP2D) Safety and tolerability will be measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5. The number of patients experiencing a dose limiting toxicity will be tabulated. The recommended phase 2 dose will be determined by the dose escalation phase using 3+3 design. 28 days (end of cycle 1)
Secondary Overall response rate (ORR) ORR will be calculated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 30 days after completion of study treatment
Secondary Duration of response (DoR) DoR will be calculated using RECIST version 1.1. The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). 30 days after completion of study treatment
See also
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Active, not recruiting NCT05026606 - Etigilimab and Nivolumab for the Treatment of Platinum-Resistant Recurrent Clear Cell Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Phase 2
Recruiting NCT05231122 - Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer Phase 2
Withdrawn NCT05295589 - Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy Phase 2
Active, not recruiting NCT02839707 - Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Phase 2/Phase 3
Not yet recruiting NCT06393751 - Testing the Addition of ASTX660 (Tolinapant) to the Usual Chemotherapy Treatment (Paclitaxel With or Without Bevacizumab) in Patients With Recurrent Ovarian Cancer Phase 1/Phase 2
Active, not recruiting NCT04739800 - Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents Phase 2
Recruiting NCT04840589 - Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors Phase 1
Active, not recruiting NCT03113487 - P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Phase 2