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REGorafenib vsTamoxifen in Patients With Platinum-sensitive OVARian Carcinoma and Isolated Biological Progression (REGOVAR)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02584465
Recruitment Status : Active, not recruiting
First Posted : October 22, 2015
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

Brief Summary:
The objective of this randomized phase II is to evaluate the benefit of regorafenib for ovarian patients who reported a confirmed elevated CA-125 level under surveillance or bevacizumab, compared with tamoxifen.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Drug: Tamoxifen Drug: Regorafenib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Comparative, Multicenter, Phase II Study of the Efficacy and Safety of REGorafenib Versus Tamoxifen in Patients With Platinum-sensitive OVARian Carcinoma and Isolated Biological Progression
Actual Study Start Date : August 28, 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Active Comparator: A-Tamoxifen
Tamoxifen 40mg/day 2 film-coated tablet containing 20 mg of Tamoxifen/day until progression
Drug: Tamoxifen
Tamoxifen: 40 mg/day

Experimental: B-Regorafenib
Regorafenib 120mg/day 3 film-coated tablet containing 40 mg of Regorafenib/day, 3 weeks/4 until progression
Drug: Regorafenib
Stivarga; 120mg/day




Primary Outcome Measures :
  1. Progression Free survival (PFS) [ Time Frame: 4 months ]
    PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 4 months ]
  2. Time to start of first subsequent chemotherapy (TFST) [ Time Frame: 5 months ]
  3. Second progression-Free Survival (PFS2) [ Time Frame: 6 months ]
    PFS2 based on the investigator's assessment.

  4. Overall Survival (OS) [ Time Frame: 7 months ]
  5. Adverse events [ Time Frame: 7 months ]
    frequency of adverse events according to MedDRA terms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

I2 Histological confirmation of epithelial ovarian, fallopian tube, or primary peritoneal cancer, I3 Rising CA-125 (according to the Rustin/GCIG criteria, see appendix 10)) occurring more than 6 months after the last platinum-based chemotherapy cycle (platinum sensitive), I4 No symptom related to ovarian cancer progression, I6 1 or 2 prior lines of platinum-based chemotherapy followed either by surveillance or bevacizumab or olaparib (outside therapeutic trial) maintenance, I7 Before randomization, patients must be in CR, PR or SD (RECIST version 1.1) under surveillance or maintenance with bevacizumab or olaparib,

I8 Adequate bone marrow, liver and renal functions as assessed by the following laboratory tests conducted within 7 days before randomization:

  • Absolute Neutrophil Count ≥ 1.5 G/L, platelets count ≥ 100 G/L, and hemoglobin ≥ 9g/dL,
  • AST/ALT ≤ 3 x upper limit of normal (ULN) (or ≤ 5.0 x ULN if liver metastasis) and total bilirubin ≤ 1.5 x ULN, Alkaline phosphatase ≤ 2.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN,
  • Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m² according to the Modification of Diet Renal Disease (MDRD) abbreviated formula
  • Lipase ≤ 1.5 x ULN
  • Prothrombine time-international normalized ratio (PT-INR) < 1.5 x ULN. Patients who are therapeutically anticoagulated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in this parameter exists, I9 Women of childbearing potential and partners must agree to use adequate contraceptive method (if no previous bilateral annexectomies) during the whole study period and for up to 6 months after the last dose of study treatment; a negative pregnancy test must be obtained prior to randomization,

Main Exclusion Criteria:

E4 Past or concurrent history of neoplasm other than ovarian cancer, except for in situ carcinoma of the cervix uteri, in situ breast cancer and/or basal cell epithelioma. All treats and cures cancer more than 3 years before the study entry is allowed E5 Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system (CNS) disease if the patient has symptoms suggestive or consistent with progressive CNS disease), E6 Any prior radiotherapy to the pelvis or abdomen; surgery (including open biopsy) within 4 weeks before starting study drugs (24 hours for minor surgical procedures), or planned major surgery during the study treatment period, E7 Any prior treatment with anti angiogenic agent such as pazopanib, nintedanib or cediranib.

E8 Endocrine therapy administered within 3 years prior to randomization,

E13 History of any of the following :

  • abdominal fistula,
  • gastrointestinal perforation,
  • intra-abdominal abscess,
  • any malabsorption condition, E14 Clinically significant bleeding NCI-CTCAE version 4.3 Grade 3 or higher within 30 days before randomization, E15 Congestive heart failure New York Heart Association (NYHA) ≥ class 2, E17 Uncontrolled hypertension (systolic blood pressure (BP) > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management), E21 Ongoing infection > Grade 2 according to NCI-CTCAE version 4.3. Hepatitis B is allowed if no active replication is present. Hepatitis C is allowed if no antiviral treatment is required, E23 Interstitial lung disease with ongoing signs and symptoms at the time of screening,

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): NCT02584465


Locations
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Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Bayer
Investigators
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Principal Investigator: Olivier Olivier, MD olivier.tredan@lyon.unicancer.fr

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Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT02584465    
Other Study ID Numbers: GINECO-OV235
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents