Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02898207
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic High Grade Fallopian Tube Serous Adenocarcinoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Primary Peritoneal Serous Adenocarcinoma
  • Metastatic Triple-Negative Breast Carcinoma
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Recurrent Breast Carcinoma
  • Recurrent High Grade Fallopian Tube Serous Adenocarcinoma
  • Recurrent High Grade Ovarian Serous Adenocarcinoma
  • Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma
  • Recurrent Triple-Negative Breast Carcinoma
  • Refractory Fallopian Tube Serous Adenocarcinoma
  • Refractory Ovarian Serous Adenocarcinoma
  • Refractory Primary Peritoneal Serous Adenocarcinoma
  • Refractory Triple-Negative Breast Carcinoma
  • Unresectable High Grade Fallopian Tube Serous Adenocarcinoma
  • Unresectable Malignant Solid Neoplasm
  • Unresectable Primary Peritoneal Serous Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Given PO
  • Onalespib — DRUG
    Given IV

Study Details

This phase I trial studies the side effects and best dose of olaparib and onalespib when given together in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) or ovarian, fallopian tube, primary peritoneal, or triple-negative breast cancer that has come back (recurrent). Olaparib and onalespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
May 19, 2017
Status verified
Apr 2023
Primary completion
Jul 29, 2020
Completion
Jan 14, 2022

Study Design

Enrollment
28 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 0: Olaparib 200 mg and Onalespib 20 mg/m^2
    Dose Level 0 (DL0): Patients received olaparib 200 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 200mg PO BID on days 1-28 and onalespib 20 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Dose Level 1: Olaparib 200 mg and Onalespib 40 mg/m^2
    Dose Level 1 (DL1): Patients received olaparib 200 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 200mg PO BID on days 1-28 and onalespib 40 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Dose Level 2: Olaparib 300 mg and Onalespib 40 mg/m^2
    Dose Level 2 (DL2): Patients received olaparib 300 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 300 mg PO BID on days 1-28 and onalespib 40 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Dose Level 3: Olaparib 300 mg and Onalespib 80 mg/m^2
    Dose Level 3 (DL3): Patients received olaparib 300 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 300 mg PO BID on days 1-28 and onalespib 80 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Dose Level 2a: Olaparib 200 mg and Onalespib 80 mg/m^2
    Dose Level 2a (DL2a): Patients received olaparib 200 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 200 mg PO BID on days 1-28 and onalespib 80 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Dose Level 3a: Olaparib 200 mg and Onalespib 120 mg/m^2
    Dose Level 3a (DL3a): Patients received olaparib 200 mg PO BID on days 1-7 (cycle 0). Beginning in cycle 1, patients received olaparib 200 mg PO BID on days 1-28 and onalespib 120 mg/m\^2 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeated every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Olaparib Administered in Combination With Onalespib [ Time Frame: Up to 35 days for each dose level cohort ]

Locations (8)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054-
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital in Arizona· Phoenix, AZMayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLBeth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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