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BRIEF TITLE: A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Cisplatin-Ineligible Patients With Unresectable Stage IV Urothelial Cancer

A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer


  • Org Study ID: D933IC00003
  • Secondary ID:
  • NCT ID: NCT03459846
  • NCT Alias:
  • Sponsor: AstraZeneca - Industry
  • Source: AstraZeneca

Brief Summary

A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer

Detailed Description


This is a Phase II, randomized, double-blind, placebo controlled, multi-center, comparative
global study to determine the efficacy and safety of durvalumab + olaparib combination
therapy versus durvalumab + placebo (durvalumab monotherapy) as first-line treatment in
patients ineligible for platinum-based chemotherapy with unresectable Stage IV urothelial
cancer (UC).

Overal Status Start Date Phase Study Type
Recruiting March 16, 2018 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: The efficacy of Durvalumab+Olaparib combination therapy compared to Durvalumab + Placebo in terms of Progression-Free Survival (PFS) in patients with Platinum ineligible bladder cancer

Primary Outcome 1 - Time Frame: 2 years

Condition:

  • Urinary Bladder Neoplasms

Eligibility

Criteria:
Inclusion criteria:

1. Provision of signed and dated, written ICF

2. Histologically or cytologically documented TCC/UC of the urothelium (including renal
pelvis, ureters, urinary bladder, and urethra) also meeting the following:
> Unresectable, Stage IV disease; No prior systemic therapy for unresectable, Stage IV
disease.

3. Ineligible for platinum-based chemotherapy defined as (i) in the opinion of the
Investigator, unfit for carboplatin-based chemotherapy and (ii) meeting one of the
following criteria: CrCl <60 mL/min calculated by Cockcroft-Gault equation; Common
Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing loss (25
dB in 2 consecutive wave ranges); CTCAE Grade ≥2 peripheral neuropathy; New York Heart
Association Class III heart failure; ECOG 2.

4. Known tumor HRR mutation status prior to randomization.

5. World Health Organization (WHO)/ECOG performance status of 0, 1, or 2.

6. Patients with at least 1 RECIST 1.1 target lesion at baseline.

7. Ability to swallow oral medications.

8. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for
female pre-menopausal patients.

Exclusion criteria

1. Active or prior documented autoimmune or inflammatory disorders.

2. Other invasive malignancy within 5 years before the first dose of the IP.

3. Major surgical procedure within 28 days prior to the first dose

4. Brain metastases or spinal cord compression unless the patient's condition is stable
and off steroid for at least 14 days

5. History of active primary immunodeficiency.

6. Active infection including tuberculosis (TB)

7. History of allogenic organ transplantation.

8. Uncontrolled intercurrent illness

9. Prior exposure to a PARP inhibitor or immune-mediated therapy.

10. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.

11. Current or prior use of immunosuppressive medication within 14 days before the first
dose of the IP.

12. No radiation therapy is allowed, unless it is (1) definitive radiation that had been
administered at least 12 months prior; (2) palliative radiation to the brain, with
associated criteria for stability or lack of symptoms; or (3) palliative radiation to
painful bony lesions (this must comprise less than 30% of the bone marrow) or
symptomatic pelvic soft tissue mass(es).

13. Receipt of live attenuated vaccine within 30 days prior to the first dose of the IP.

14. Patients with a known hypersensitivity to durvalumab, olaparib, or any of the
excipients of the products.

15. Female patients who are pregnant or breastfeeding or male or female patients of
reproductive potential who are not willing to employ effective birth control from
screening to 90 days after the last dose of durvalumab.
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Gender: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Healthy Volunteers: No

Official Information

Name: Jonathan Rosenberg, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Locations

Facility Status Contact
Research Site
Birmingham, Alabama 35294
United States
Recruiting
Research Site
Goodyear, Arizona 85338
United States
Not yet recruiting
Research Site
Stanford, California 94305
United States
Withdrawn
Research Site
Fort Myers, Florida 33901
United States
Recruiting
Research Site
Saint Petersburg, Florida 33705
United States
Recruiting
Research Site
Tampa, Florida 33612
United States
Recruiting
Research Site
Newnan, Georgia 30265
United States
Recruiting
Research Site
Zion, Illinois 60030
United States
Withdrawn
Research Site
Louisville, Kentucky 40202
United States
Recruiting
Research Site
Baltimore, Maryland 21204
United States
Recruiting
Research Site
Detroit, Michigan 48201
United States
Withdrawn
Research Site
Bronx, New York 10461
United States
Not yet recruiting
Research Site
Buffalo, New York 14263
United States
Withdrawn
Research Site
Lake Success, New York 11042
United States
Not yet recruiting
Research Site
New York, New York 10065
United States
Not yet recruiting
Research Site
Chapel Hill, North Carolina 27599
United States
Withdrawn
Research Site
Durham, North Carolina 27710
United States
Withdrawn
Research Site
Philadelphia, Pennsylvania 19124
United States
Not yet recruiting
Research Site
Nashville, Tennessee 37232
United States
Recruiting
Research Site
Dallas, Texas 75216
United States
Withdrawn
Research Site
Fort Worth, Texas 76104
United States
Recruiting
Research Site
Seattle, Washington 98101
United States
Withdrawn
Research Site
Seattle, Washington 98104
United States
Not yet recruiting
Research Site
Tacoma, Washington 98405
United States
Recruiting
Research Site
Halifax, Nova Scotia B3H 1V7
Canada
Withdrawn
Research Site
Hamilton, Ontario L8V 5C2
Canada
Recruiting
Research Site
Newmarket, Ontario L3Y 2P9
Canada
Recruiting
Research Site
Sudbury, Ontario P3E 5J1
Canada
Recruiting
Research Site
Toronto, Ontario M5G 1X6
Canada
Not yet recruiting
Research Site
Montreal, Quebec H2X 3E4
Canada
Not yet recruiting
Research Site
Montreal, Quebec H3T 1E2
Canada
Recruiting
Research Site
Montreal, Quebec H4A 3J1
Canada
Withdrawn
Research Site
Incheon, 21565
Korea, Republic of
Recruiting
Research Site
Seoul, 02841
Korea, Republic of
Recruiting
Research Site
Seoul, 03722
Korea, Republic of
Recruiting
Research Site
Seoul, 05505
Korea, Republic of
Recruiting
Research Site
Seoul, 135-710
Korea, Republic of
Recruiting
Research Site
San Juan, 00907
Puerto Rico
Withdrawn
Research Site
San Juan, 00927
Puerto Rico
Withdrawn
Research Site
Krasnoyarsk, 660133
Russian Federation
Suspended
Research Site
Moscow, 105077
Russian Federation
Recruiting
Research Site
Moscow, 125367
Russian Federation
Recruiting
Research Site
Novosibirsk, 630108
Russian Federation
Recruiting
Research Site
Omsk, 644013
Russian Federation
Recruiting
Research Site
Saint Petersburg, 195271
Russian Federation
Recruiting
Research Site
St. Petersburg, 194354
Russian Federation
Recruiting
Research Site
St. Petersburg, 199178
Russian Federation
Suspended
Research Site
Barcelona, 08035
Spain
Recruiting
Research Site
Barcelona, 08036
Spain
Recruiting
Research Site
Málaga, 29010
Spain
Recruiting
Research Site
Santiago De Compostela(A Coru, 15706
Spain
Recruiting
Research Site
Kaohsiung, 807
Taiwan
Recruiting
Research Site
Kaohsiung,
Taiwan
Recruiting
Research Site
Taichung, 404
Taiwan
Not yet recruiting
Research Site
Taichung, 40705
Taiwan
Recruiting
Research Site
Taipei, 100
Taiwan
Recruiting
Research Site
Taipei, 104
Taiwan
Recruiting
Research Site
Taipei,
Taiwan
Recruiting
Research Site
Taoyuan City, 333
Taiwan
Recruiting
Research Site
Hanoi,
Vietnam
Recruiting
Research Site
Ho Chi Minh city,
Vietnam
Not yet recruiting
Research Site
Ho Chi Minh, 700000
Vietnam
Not yet recruiting