A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors (NCT02498613) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors
United States, Canada122 participantsStarted 2016-08-31
Plain-language summary
This phase II trial studies cediranib maleate in combination with olaparib in treating patients with solid tumors that have spread to other parts of the body (advanced/metastatic) or cannot be removed by surgery (unresectable), including breast cancer, non-small cell lung cancer, small cell lung cancer, and pancreatic cancer. Cediranib maleate and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also block the flow of oxygen to the tumor, and may help make the tumor more sensitive to olaparib.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically confirmed, metastatic or unresectable malignancy of the following types: (a) non-small cell lung cancer (NSCLC), (b) triple-negative breast cancer (TNBC; defined by estrogen receptor \[ER\] \< 1%, progesterone receptor \[PR\] \< 1% and HER2 1+ or less by immunohistochemistry \[IHC\]; if HER-2 expression is 2+, a negative fluorescence in situ hybridization \[FISH\] testing is required) (c) pancreatic adenocarcinoma (PDAC), or (d) small cell lung cancer (SCLC)
* Must have received at least one line of standard systemic treatment for locally advanced or metastatic disease setting of the respective tumor type; for NSCLC, it is either PD-1/PD-L1 inhibitor, or platinum-containing chemotherapy, or an EGFR tyrosine kinase inhibitor or an ALK inhibitor if sensitizing mutation present; TNBC: platinum-containing chemotherapy; PDAC: fluorouracil (5-FU-), gemcitabine-, or taxane-containing chemotherapy either with or without radiation therapy; SCLC: platinum-containing chemotherapy for limited or extensive stage disease
* Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
* Toxicities of prior therapy (except alopecia) should be resolved to =\< grade 1 as per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0; patients with long-standing stable grade 2 neuropathy or prior grade 2 treatment-related hypothyroidism requiring tr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial combining two drugs — cediranib and olaparib — and it's measuring objective response rate, meaning how many patients' tumors actually shrink; given that Phase 2 is still an intermediate stage of testing, what do we know so far about how well this combination actually works for my specific cancer type like triple-negative breast cancer or small cell lung cancer?
2The trial is listed as 'active but no longer recruiting,' which means new patients can't join — but could you look into whether there are related or follow-up trials testing cediranib or olaparib combinations that I might still be eligible for?
3Cediranib targets blood vessel growth and olaparib targets DNA repair, so combining them can affect multiple body systems at once; what kinds of side effects or safety risks should I be especially aware of with this two-drug combination, particularly for someone with my health history?
4Since this trial covers several very different cancer types — from pancreatic adenocarcinoma to non-small cell lung cancer to triple-negative breast cancer — does the data suggest the combination works better for some cancer types than others, and how does that compare to the standard treatments available for my specific diagnosis?
5Before considering an experimental combination like this, would you recommend I try the current standard-of-care options first, or is there a reason based on my tumor's biology — like BRCA mutations or other markers — that might make this kind of trial worth prioritizing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate
Timeframe: Up to 4 weeks after completion of study treatment (Up to 43 months)