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PARP Inhibitor
Selumetinib + Olaparib for Cancer
Phase 1
Waitlist Available
Led By Shannon Westin, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.03) </= Grade 1 at the time of screening (except alopecia)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment initiation
Concomitant use of specified medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Summary
This trial has two phases: in the first, they'll find the highest dose of the drugs that patients can tolerate; in the second, they'll see if that dose can help control patients' advanced or recurrent solid tumors. Safety will also be monitored in both phases.
Who is the study for?
Adults with advanced or recurrent solid tumors, including various cancers like breast, thyroid, and cervical cancer. Participants must have a life expectancy of at least 16 weeks and be able to follow the study protocol. Women should not be pregnant or breastfeeding and must use effective contraception; men also need to use condoms. Patients should have adequate organ function and may have had any number of prior chemotherapy treatments but must be recovered from major surgeries or previous treatment side effects.
What is being tested?
The trial is testing Selumetinib in combination with Olaparib for treating advanced solid tumors over two phases: finding the highest tolerable dose (Phase 1) and then seeing if that dose can control the cancer (Phase 2). Selumetinib isn't FDA approved yet; it's being researched. Olaparib is approved for ovarian cancer with specific genetic mutations but its combination with Selumetinib is investigational.
What are the potential side effects?
Potential side effects include typical reactions such as fatigue, digestive issues, blood disorders, allergic reactions to medication components, possible lung inflammation (pneumonitis), risk of infection due to immunosuppression, myelodysplastic syndrome/acute myeloid leukemia development risks, among others based on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My side effects from previous treatments are mild, except for hair loss.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am postmenopausal or cannot become pregnant.
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I am using two effective birth control methods.
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I will use a condom during and for 3 months after treatment if my partner could get pregnant.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.
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I am currently taking certain medications.
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I have had cancer before, but it fits the exceptions listed.
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I am currently experiencing symptoms of lung inflammation.
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I cannot swallow pills or have a stomach condition that affects medication absorption.
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I have not taken MEK inhibitors for my condition.
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I have been diagnosed with or show signs of myelodysplastic syndrome or acute myeloid leukemia.
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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using birth control.
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My heart condition fits the specified criteria.
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I have had a bone marrow or double cord blood transplant.
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I am not using other cancer treatments or live vaccines while on the study medication.
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I do not have any severe or uncontrolled illnesses.
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I don't have lasting side effects from cancer treatment, except for hair loss.
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I am not allergic to selumetinib, olaparib, or similar medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose (MTD) for Combination of Selumetinib and Olaparib in Participants with Advanced or Recurrent Solid Tumors
Secondary study objectives
Anti-Tumor Activity Evaluation by RECIST v1.1
Comparison of Baseline Expression Values with Differing Treatment Responses of Selumetinib and Olaparib
Determination of Drug Concentration in Selumetinib and Olaparib
Side effects data
From 2012 Phase 2 trial • 37 Patients • NCT0108521475%
Diarrhea
50%
Fatigue
47%
Anemia
47%
Rash acneiform
44%
Hypoalbuminemia
44%
Edema, limbs
39%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
33%
White blood cell decreased
31%
Nausea
31%
Vomiting
28%
Platelet count decreased
25%
CPK increased
25%
Hypomagnesemia
22%
Hypertension
19%
Hyponatremia
19%
Hypophosphatemia
19%
Hypocalcemia
19%
Edema, face
17%
Dry skin
17%
Alanine aminotransferase increased
14%
Skin and subcutaneous tissue disorders - Other
14%
Hypokalemia
14%
Creatinine increased
14%
Back pain
14%
Dyspnea
14%
Lymphocyte count decreased
11%
Pain
11%
Fever
11%
Localized edema
11%
Peripheral sensory neuropathy
11%
Hyperkalemia
11%
Dizziness
11%
Abdominal pain
8%
Anorexia
8%
Hypoglycemia
8%
Acute kidney injury
8%
Death, NOS
8%
Periorbital edema
8%
Skin hypopigmentation
8%
Pain in extremity
8%
Cough
8%
Insomnia
8%
Alkaline phosphatase increased
8%
Dry mouth
8%
Sepsis
6%
Hypercalcemia
6%
Hypernatremia
6%
Metabolism and nutrition disorders - Other
6%
Blood and lymphatic system disorders - Other
6%
Renal and urinary disorders - Other
6%
Dehydration
6%
Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis
6%
Chills
6%
Hypotension
6%
Myalgia
6%
Arthralgia
6%
Upper respiratory infection
6%
Headache
6%
Sinusitis
6%
Generalized muscle weakness
6%
Gastrointestinal disorders - Other
6%
Gastroesophageal reflux disease
3%
Pruritus
3%
Confusion
3%
Vaginal inflammation
3%
Febrile neutropenia
3%
Flu like symptoms
3%
Hepatic failure
3%
Skin infection
3%
Fall
3%
Fracture
3%
Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral
3%
Adult respiratory distress syndrome
3%
Renal and urinary disorders - Other, Acute renal failure
3%
INR increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD6244 (Selumetinib) Treatment
Trial Design
5Treatment groups
Experimental Treatment
Group I: Solid Tumors that Harbor Somatic RPAExperimental Treatment2 Interventions
Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase.
Group II: Selumetinib + OlaparibExperimental Treatment2 Interventions
Dose Escalation Phase: Participants take both Selumetinib and Olaparib by mouth 2 times each day, about 12 hours apart at the Starting Dose Level. Treatment cycle is 28 days.
When maximum tolerated dose reached, Dose Expansion Phase begins.
Group III: Ovarian Cancer-Progression-prior PARP TreatmentExperimental Treatment2 Interventions
Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase.
Group IV: Ovarian Cancer with RPAExperimental Treatment2 Interventions
Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase.
Group V: Endometrial Cancer with RPAExperimental Treatment2 Interventions
Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selumetinib
2010
Completed Phase 2
~2080
Olaparib
2007
Completed Phase 4
~2190
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,611 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,719 Total Patients Enrolled
176 Trials studying Breast Cancer
1,245,578 Patients Enrolled for Breast Cancer
Shannon Westin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
383 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a lot of lung disease in both sides of your lungs as shown on a special type of X-ray called HRCT scan.My side effects from previous treatments are mild, except for hair loss.I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.I am currently taking certain medications.I have had cancer before, but it fits the exceptions listed.My brain or spinal metastases have been stable for 4 weeks without steroids or seizure meds.I am currently experiencing symptoms of lung inflammation.I am using two effective birth control methods.I will use a condom during and for 3 months after treatment if my partner could get pregnant.I cannot swallow pills or have a stomach condition that affects medication absorption.I have not taken MEK inhibitors for my condition.I have had multiple chemotherapy treatments.I am fully active or restricted in physically strenuous activity but can do light work.I have not had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.A) You have advanced or recurrent ovarian or endometrial cancer, or another type of solid tumor, and have not responded well to previous treatment.
B) Your disease can be measured and biopsied.
C) You are willing to have a biopsy.
D) You have received treatment with PARP inhibitors before.I have been diagnosed with or show signs of myelodysplastic syndrome or acute myeloid leukemia.I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using birth control.My heart condition fits the specified criteria.I have had a bone marrow or double cord blood transplant.My advanced cancer has not responded to standard treatments or has come back after such treatments.I have at least one tumor that can be measured.My organs and bone marrow are functioning well.I am willing and able to follow the study's requirements, including treatments and visits.I am postmenopausal or cannot become pregnant.I am not using other cancer treatments or live vaccines while on the study medication.I do not have any severe or uncontrolled illnesses.I have specific gene changes and may have been treated with MEK or PARP inhibitors.I am 18 years old or older.I don't have lasting side effects from cancer treatment, except for hair loss.I have ovarian cancer with symptoms like fluid buildup, even if tumors can't be measured.You are expected to live for at least 16 weeks.You have certain eye conditions as listed in the study requirements.I have not received a whole blood transfusion in the last 4 months.I am not allergic to selumetinib, olaparib, or similar medications.People with weakened immune systems, such as those who are HIV-positive, cannot participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Endometrial Cancer with RPA
- Group 2: Selumetinib + Olaparib
- Group 3: Solid Tumors that Harbor Somatic RPA
- Group 4: Ovarian Cancer with RPA
- Group 5: Ovarian Cancer-Progression-prior PARP Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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