Solid TumorsPhase 1NCT02439489
Study of the Combination of BKM120 and Cisplatin or Carboplatin in Patients With Advanced Solid Tumors
A Phase 1 study testing BKM120-CIS and BKM120-CARBO in people with Solid Tumors, run by Fondazione Michelangelo at 1 site in Italy.
Trial summary
PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of PI3K (e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive towards PI3K-pathway inhibition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- BKM120-CIS and BKM120-CARBO
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to 31 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has provided a signed Informed Consent Form (ICF) obtained prior to any screening procedure;
- Patient is ≥ 18 years at the day of consenting to the study
- Patient has an ECOG performance status ≤ 1
- Pathologically confirmed recurrent or metastatic advanced solid tumor, for which treatment with a platinum agent is indicated
- Life expectancy ≥ 6 months
- Patient has adequate bone marrow and organ function
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- Patient must be able to swallow and retain oral medication
- Patient may have received more than 1 prior cytotoxic chemotherapy regimens for recurrent or metastatic disease
- Negative serum pregnancy test within 48 hours before starting study treatment in women with childbearing potential
- Patients may receive concurrent radiation therapy to painful bone metastases or areas of impending bone fracture
- Patients must be disease-free of other prior invasive cancers for > 5 year
- Patients must complete all screening assessments as outlined in the protocol
Who cannot join
- Patient has received previous treatment with PI3K and/or mTOR inhibitors
- Patient has received chemotherapy or targeted anticancer therapy ≤ 4 weeks prior to starting study drug or has not recovered from side effects of such therapy
- Patient has symptomatic CNS metastases (Patients with controlled and asymptomatic CNS metastases may participate in this trial)
- Patient has any of the below mood disorders as judged by the Investigator or a Psychiatrist, or meets the cut-off score of ≥ 10 in the PHQ-9 or a cut-off of ≥ 15 in the GAD-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of the PHQ-9)
- Patient is concurrently using other approved or investigational antineoplastic agent
- Patient has received wide field radiotherapy ≤ 4 weeks prior to starting study drug
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- Patient has had major surgery within 2 weeks days prior to starting study drug;
- Patients with diabetes mellitus or steroid-induced diabetes mellitus or known intolerance to glucides or fasting glucose > 120 mg/dL or HbA1c > 8 %
- Patient has important cardiac disease
- LVEF < 50%; NYHA Class III or IV
- QTc > 480 msec; Congenital long QT syndrome
- Clinically significant resting bradycardia
- Complete left bundle branch block; Right bundle branch block + left anterior hemiblock
- Patient has impairment of GI function or GI disease
- Patient receiving chronic treatment with steroids or another immunosuppressive agent.
- Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate his/her participation in the clinical study (e.g.,chronic pancreatitis, active or chronic liver disease, renal disease etc.)
- Patient has diarrhea ≥ 2 CTCAE grade 2
- Preexisting peripheral neuropathy > grade 1
- Patient has been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug
- Prior hypersensitivity reaction to carboplatin or cisplatin
- Patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or patient has a history of non-compliance to medical regimen
- Patient is currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
- Patient has a known history of HIV (infection; 21. Patient is a pregnant or nursing (lactating) woman
- Patient is a man or woman of childbearing potential unwilling to use a double barrier method for birth control throughout the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib Study of the Combination of BKM120 and Cisplatin or Carboplatin in Patients With Advanced Solid Tumors
PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of PI3K (e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive towards PI3K-pathway inhibition. BKM120 is a potent and highly specific oral pan-class I PI3K-inhibitor.
The study FM-11-F01b is a phase Ib single institution study using the combination of BKM120 and cisplatin or carboplatin in patient with pathologically confirmed recurrent or metastatic advanced solid tumor, for which treatment with a platinum agent is indicated (preferentially head and neck, NSCLC, ovary, endometrial).
The primary objective of the study is to define the phase II recommended dose of daily oral BKM120 and cisplatin (Group 1) or carboplatin (Group 2), given intravenously (IV) on day 1 every 3 weeks.
Read the detailed description
Despite recent progresses in antineoplastic therapy durable cancer remission is still infrequent in many solid tumors and new treatment options are needed for patients whose cancer has progressed following standard therapies. There is an increasing interest of evaluating new combinations of cytotoxics with new molecule targeted agents which could increase antitumor activity.
PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of PI3K (e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive towards PI3K-pathway inhibition. BKM120 is a potent and highly specific oral pan-class I PI3K-inhibThe study FM-11-F01b is a phase Ib single institution study using the combination of BKM120 and cisplatin or carboplatin in patient with pathologically confirmed recurrent or metastatic advanced solid tumor, for which treatment with a platinum agent is indicated (preferentially head and neck, NSCLC, ovary, endometrial).
itor. The study treatment foreseen BKM120 administered on a continuous once daily dosing schedule at a dose of 60, 80 or 100 mg (p.o.) plus Carboplatin or Cisplatin. Cisplatin 75 mg/mq will be administered as a 2 hours intravenous infusion every 3 weeks. Carboplatin AUC 5 (or AUC 6 if dose level 3 has been completed) will be administered as a 30 minutes intravenous infusion diluted in 250 mL of normal saline every 3 weeks.
This is a single institution phase I study. Up to 3 dose levels of daily BMK120 will be studied. A standard 3 + 3 phase I dose escalation design will be used for both Group 1 and Group 2. Dose escalation in Group 1 and Group 2 will be mutually independent.
The primary objective of the study is to define the phase II recommended dose of daily oral BKM120 and cisplatin (Group 1) or carboplatin (Group 2), given intravenously (IV) on day 1 every 3 weeks. BKM120 and carboplatin or cisplatin.
- Conditions
- Solid Tumors
- Being tested
- BKM120-CIS, BKM120-CARBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKM120-CISDrug
Also called Buparlisib (BKM120), CISPLATINO TEVA
BKM120 will be delivered orally once daily on continuous at the dose of 60 mg (dose level 1), 80 mg (dose level 2) and 100 (dose level 3). Cisplatin will be delivered intravenously at the dose of 75 mg/m2 on day 1 every 3 weeks at each dose level of BKM120.
In the absence of BKM120 DLT, each level will be administered to 3 patients A minimum of 2 cycles per each dose level will be administered in the absence of disease progression or toxicity
BKM120-CARBODrug
Also called Buparlisib (BKM120), CARBOPLATIN TEVA
BKM120 will be delivered orally once daily on continuous at the dose of 60 mg (dose level 1), 80 mg (dose level 2) and 100 (dose level 3). Carboplatin will be delivered intravenously at AUC 5 on day 1 every 3 weeks at each dose level of BKM120. Should dose level 3 be completed, carboplatin will be given at AUC 6 and BKM120 at 100 mg.
In the absence of BKM120 DLT, each level will be administered to 3 patients A minimum of 2 cycles per each dose level will be administered in the absence of disease progression or toxicity
| Study group | Role | What they receive |
|---|---|---|
| BKM120-CIS | Experimental | BKM120 (60, 80 100 mg po continuously) and Cisplatin (iv 75 mg/m2) Receives: Drug: BKM120-CIS |
| BKM120-CARBO | Experimental | BKM120 and (60, 80 100 mg po continuously) and Carboplatin (iv AUC 5) Receives: Drug: BKM120-CARBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities in each of the study dose levels
Determination of phase II recommended dose of daily oral BKM120 and cisplatin (Group 1) or carboplatin (Group 2), based upon drug related Dose Limiting Toxicities as described in the protocol at the end of Cycle 1 (each cycle is 22 days)
Measured: 36 months
Secondary outcomes (1)
Response rate
Defined as the percentage of complete or partial responders assessed by RECIST criteria (v1.1)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startDec 2012
- Primary completion9 Jun 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Michelangelo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Gianni, MD, Study chair, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439489
- Sponsor's protocol ID
- FM-11-F01b
- Status last verified
- Feb 2018
- First submitted
- 21 Apr 2015
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of the Combination of BKM120 and Cisplatin or Carboplatin in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02439489
- Acronym / sponsor ID
- FM-11-F01b
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fondazione MichelangeloUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- 9 Jun 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of PI3K (e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive towards PI3K-pathway inhibition. BKM120 is a potent and highly specific oral pan-class I PI3K-inhibitor.
The study FM-11-F01b is a phase Ib single institution study using the combination of BKM120 and cisplatin or carboplatin in patient with pathologically confirmed recurrent or metastatic advanced solid tumor, for which treatment with a platinum agent is indicated (preferentially head and neck, NSCLC, ovary, endometrial).
The primary objective of the study is to define the phase II recommended dose of daily oral BKM120 and cisplatin (Group 1) or carboplatin (Group 2), given intravenously (IV) on day 1 every 3 weeks.
Detailed description
Despite recent progresses in antineoplastic therapy durable cancer remission is still infrequent in many solid tumors and new treatment options are needed for patients whose cancer has progressed following standard therapies. There is an increasing interest of evaluating new combinations of cytotoxics with new molecule targeted agents which could increase antitumor activity.
PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of PI3K (e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive towards PI3K-pathway inhibition. BKM120 is a potent and highly specific oral pan-class I PI3K-inhibThe study FM-11-F01b is a phase Ib single institution study using the combination of BKM120 and cisplatin or carboplatin in patient with pathologically confirmed recurrent or metastatic advanced solid tumor, for which treatment with a platinum agent is indicated (preferentially head and neck, NSCLC, ovary, endometrial).
itor. The study treatment foreseen BKM120 administered on a continuous once daily dosing schedule at a dose of 60, 80 or 100 mg (p.o.) plus Carboplatin or Cisplatin. Cisplatin 75 mg/mq will be administered as a 2 hours intravenous infusion every 3 weeks. Carboplatin AUC 5 (or AUC 6 if dose level 3 has been completed) will be administered as a 30 minutes intravenous infusion diluted in 250 mL of normal saline every 3 weeks.
This is a single institution phase I study. Up to 3 dose levels of daily BMK120 will be studied. A standard 3 + 3 phase I dose escalation design will be used for both Group 1 and Group 2. Dose escalation in Group 1 and Group 2 will be mutually independent.
The primary objective of the study is to define the phase II recommended dose of daily oral BKM120 and cisplatin (Group 1) or carboplatin (Group 2), given intravenously (IV) on day 1 every 3 weeks. BKM120 and carboplatin or cisplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BKM120-CIS | Experimental | Drug: BKM120-CISBKM120 (60, 80 100 mg po continuously) and Cisplatin (iv 75 mg/m2) |
| BKM120-CARBO | Experimental | Drug: BKM120-CARBOBKM120 and (60, 80 100 mg po continuously) and Carboplatin (iv AUC 5) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient has provided a signed Informed Consent Form (ICF) obtained prior to any screening procedure;
- Patient is ≥ 18 years at the day of consenting to the study
- Patient has an ECOG performance status ≤ 1
- Pathologically confirmed recurrent or metastatic advanced solid tumor, for which treatment with a platinum agent is indicated
- Life expectancy ≥ 6 months
Key exclusion criteria (24 listed)
- Patient has received previous treatment with PI3K and/or mTOR inhibitors
- Patient has received chemotherapy or targeted anticancer therapy ≤ 4 weeks prior to starting study drug or has not recovered from side effects of such therapy
- Patient has symptomatic CNS metastases (Patients with controlled and asymptomatic CNS metastases may participate in this trial)
- Patient has any of the below mood disorders as judged by the Investigator or a Psychiatrist, or meets the cut-off score of ≥ 10 in the PHQ-9 or a cut-off of ≥ 15 in the GAD-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of the PHQ-9)
- Patient is concurrently using other approved or investigational antineoplastic agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BKM120-CISAlso: Buparlisib (BKM120), CISPLATINO TEVABKM120 will be delivered orally once daily on continuous at the dose of 60 mg (dose level 1), 80 mg (dose level 2) and 100 (dose level 3). Cisplatin will be delivered intravenously at the dose of 75 mg/m2 on day 1 every 3 weeks at each dose level of BKM120. In the absence of BKM120 DLT, each level will be administered to 3 patients A minimum of 2 cycles per each dose level will be administered in the absence of disease progression or toxicity | Drug | BKM120-CIS |
| BKM120-CARBOAlso: Buparlisib (BKM120), CARBOPLATIN TEVABKM120 will be delivered orally once daily on continuous at the dose of 60 mg (dose level 1), 80 mg (dose level 2) and 100 (dose level 3). Carboplatin will be delivered intravenously at AUC 5 on day 1 every 3 weeks at each dose level of BKM120. Should dose level 3 be completed, carboplatin will be given at AUC 6 and BKM120 at 100 mg. In the absence of BKM120 DLT, each level will be administered to 3 patients A minimum of 2 cycles per each dose level will be administered in the absence of disease progression or toxicity | Drug | BKM120-CARBO |
Primary outcome
Number of participants with dose limiting toxicities in each of the study dose levels
Time frame: 36 months
Determination of phase II recommended dose of daily oral BKM120 and cisplatin (Group 1) or carboplatin (Group 2), based upon drug related Dose Limiting Toxicities as described in the protocol at the end of Cycle 1 (each cycle is 22 days)
1 secondary outcome
Response rate
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Gianni, MD study chair
Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BKM120-CIS and BKM120-CARBO in people with Solid Tumors, run by Fondazione Michelangelo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities in each of the study dose levels (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.