← Back to Search

PARP Inhibitor

Olaparib for Fallopian Tube Serous Adenocarcinoma

Phase 1
Waitlist Available
Led By Panagiotis A Konstantinopoulos
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ovarian, fallopian tube, or primary peritoneal cancer of high grade serous histology which has recurred despite standard therapy; up to 3 prior lines in the platinum resistant setting (i.e. up to 3 lines after patients have become platinum resistant); patients may have received unlimited lines while platinum sensitive
Triple-negative breast cancer (TNBC) which has recurred despite standard therapy; recurrent TNBC needs to have metastatic disease and patients with an in breast recurrence are not eligible; up to 4 prior lines in the recurrent setting for patients with triple-negative breast cancer are allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 2 years
Awards & highlights

Study Summary

This trial studies the side effects and best dose of two drugs, olaparib and onalespib, when given together to treat patients with metastatic or unresectable solid tumors, or ovarian, fallopian tube, primary peritoneal, or triple-negative breast cancer that has come back.

Eligible Conditions
  • Fallopian Tube Serous Adenocarcinoma
  • Cancer
  • Peritoneal Serous Adenocarcinoma
  • Breast Cancer
  • Fallopian Tube Carcinoma
  • Ovarian Cancer
  • Peritoneal Carcinoma
  • Ovarian Serous Adenocarcinoma
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of Olaparib Administered in Combination With Onalespib
Maximum Tolerated Dose (MTD) of Onalespib Administered in Combination With Olaparib
Secondary outcome measures
Number of Participants Progression-Free for At Least 24 Weeks by RECIST 1.1
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Number of Participants Who Experienced Treatment-Related Toxicities
+1 more
Other outcome measures
Change in BRCA1 foci in tumor tissue
Change in PARP activities
Change in RAD51 foci in tumor tissue
+2 more

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Dizziness
9%
Thrombocytopenia
9%
Aspartate aminotransferase increased
9%
Hyperglycaemia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Dysgeusia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
General physical health deterioration
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

Trial Design

6Treatment groups
Experimental Treatment
Group I: Dose Level 3a: Olaparib 200 mg and Onalespib 120 mg/m^2Experimental Treatment2 Interventions
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.
Group II: Dose Level 3: Olaparib 300 mg and Onalespib 80 mg/m^2Experimental Treatment2 Interventions
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.
Group III: Dose Level 2a: Olaparib 200 mg and Onalespib 80 mg/m^2Experimental Treatment2 Interventions
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.
Group IV: Dose Level 2: Olaparib 300 mg and Onalespib 40 mg/m^2Experimental Treatment2 Interventions
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.
Group V: Dose Level 1: Olaparib 200 mg and Onalespib 40 mg/m^2Experimental Treatment2 Interventions
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.
Group VI: Dose Level 0: Olaparib 200 mg and Onalespib 20 mg/m^2Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Onalespib
2017
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,618 Total Patients Enrolled
19 Trials studying Fallopian Tube Serous Adenocarcinoma
10,313 Patients Enrolled for Fallopian Tube Serous Adenocarcinoma
Panagiotis A KonstantinopoulosPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
2 Previous Clinical Trials
70 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what maladies is Olaparib commonly prescribed?

"Olaparib has been clinically proven to treat advance directives, malignant neoplasms of the ovary, and primary peritoneal cancer."

Answered by AI

Is this innovative clinical trial the first of its kind?

"Since 2005, the pharmaceutical company AstraZeneca has been researching Olaparib. After a successful Phase 1 trial involving 98 patients in that same year, there are 191 studies active across 60 different nations and 1469 cities."

Answered by AI

Could you please detail the geographical distribution of this medical study in North America?

"This medical trial is conducted at 8 sites across the United States. These locations are based in Jacksonville, Scottsdale and Phoenix as well as additional cities. To reduce travel burdens, it's recommended to select the nearest clinic if you intend to participate."

Answered by AI

What is the size of the sample population for this research project?

"Unfortunately, this trial is not accepting applications at the moment. The listing was first published on May 19th 2017 and its details were most recently revised on December 9 2021. Should you be interested in other opportunities, there are 803 clinical trials enrolling patients with unresectable high grade fallopian tube serous adenocarcinoma as well as 191 studies that have Olaparib treatments available for participants."

Answered by AI

What adverse effects can arise from the use of Olaparib?

"Olaparib's safety is still largely unknown, engendering a score of 1. This drug is currently in its first phase of clinical trials, and data on both efficacy and safety are limited."

Answered by AI

Has Olaparib been subject to any prior investigations?

"Presently, 191 clinical trials are evaluating Olaparib's efficacy with 27 of those in the late-stage Phase 3. Despite many studies occurring within Houston, Texas; there is a total of 9265 research sites disseminated throughout the world studying Olaparib."

Answered by AI

Is this experiment currently accepting participants?

"This trial has ceased to recruit any further participants. It was published on May 19th 2017 and had its last edit made December 9th 2021. Presently, there are 8003 studies open for people with unresectable high grade fallopian tube serous adenocarcinoma and 191 clinical trials utilising Olaparib actively searching for enrollees."

Answered by AI
~4 spots leftby Mar 2025