Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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|ClinicalTrials.gov Identifier: NCT03579316|
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Drug: Adavosertib Drug: Olaparib||Phase 2|
I. To determine the objective response rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) of adavosertib (AZD1775) alone or in combination with olaparib in women with recurrent ovarian cancer in whom progression has been documented following poly ADP-ribose polymerase (PARP) inhibitor therapy.
I. To evaluate the overall safety and tolerability of AZD1775 alone or in combination with olaparib in this population.
II. To evaluate the disease control rate (DCR) = overall response rate (ORR) plus stable disease rate for 16 weeks.
III. To evaluate the progression free survival (PFS) and overall survival (OS) of this population following AZD1775 alone or in combination with olaparib.
IV. To evaluate the duration of response by RECIST version (v)1.1.
I. To evaluate the efficacy of each arm by BRCA-mutation status (BRCA-mt) and homologous recombination deoxyribonucleic acid (DNA) repair deficiencies (HRD).
II. To describe endogenous and dynamic markers of DNA damage response in tumor tissue and circulating surrogates, such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA), exosomes (cellular/nuclear), cell cycle kinetics (CDKs), and immunophenotype.
III. To examine genomic alterations associated with response and mechanisms of resistance to olaparib and/or AZD1775.
OUTLINE: Patients are randomized to 1 of 2 arms. If enrollment pauses for 1 arm, patients will be assigned to the enrolling arm.
ARM I: Patients receive adavosertib orally (PO) once daily (QD) on days 1-5 and 8-12. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive olaparib PO twice daily (BID) on days 1-21 and adavosertib PO QD on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized 2-Arm, Non-Comparative Phase 2 Study of AZD1775 Alone or AZD1775 and Olaparib in Ovarian Cancer Patients Who Have Progressed During PARP Inhibition|
|Actual Study Start Date :||December 7, 2018|
|Estimated Primary Completion Date :||October 30, 2022|
|Estimated Study Completion Date :||October 30, 2023|
Active Comparator: Arm I (adavosertib)
Patients receive adavosertib PO QD on days 1-5 and 8-12. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (olaparib, adavosertib)
Patients receive olaparib PO BID on days 1-21 and adavosertib PO QD on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Objective response rate defined as complete response (CR) or partial response (PR), assessed by Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: Up to 6 months ]Will be computed and presented along with an exact 90% confidence interval using the method of Clopper and Pearson.
- Disease control rate defined as the percentage of patients with a confirmed best overall response of complete response or partial response, or a best overall response of stable disease [ Time Frame: Up to 6 months ]The point estimate per treatment arm and the 95% Pearson-Clopper confidence interval for the objective response rates will be provided. Logistic regression analyses will be performed to assess the influence of baseline covariates in an exploratory manner.
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): NCT03579316
|Contact: Robert Colemanemail@example.com|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Joyce F. Liu firstname.lastname@example.org|
|Principal Investigator: Joyce F. Liu|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Robert L. Coleman 713-745-3357|
|Principal Investigator: Robert L. Coleman|
|Principal Investigator:||Robert L Coleman||M.D. Anderson Cancer Center|